Daily Arm Research Articles

Clinician and patient experiences with shared decision-making to promote daily arm use for individuals with chronic stroke: an exploratory qualitative study.

To explore the attitudes and experiences of clinicians and individuals with chronic stroke on the use of shared decision-making (SDM) during upper extremity rehabilitation to improve daily arm use in the home environment. Specifically, we aimed to describe clinician and client perspectives regarding the facilitators and barriers to using SDM within the context of a self-directed upper extremity intervention for individuals living in the community with chronic stroke. Data were collected within the context of an interventional study examining the feasibility of the Use My Arm-Remote intervention. Focus group interviews were conducted with the clinicians (n = 3) providing the intervention and individual semi-structured interviews with the participants (n = 15) of the study. All interview data were collected after the end of the intervention period. Data were analyzed using thematic analysis. The following themes were identified: (1) Equal partnership; (2) Enhancing clinician confidence; and (3) This is different. Facilitators and barriers were identified within each theme. Key facilitators for clinicians were competence with SDM and patient characteristics; while facilitators for patients were open and trusting relationships with clinicians and personalized experience. Key barriers to SDM for clinicians were lack of expertise in SDM and participant buy in; while patients identified a lack of foundational knowledge of stroke rehabilitation as a potential barrier. Key barriers were analyzed using the consolidated framework for advancing implementation science to interpret results and identify strategies for enhancing the implementation of SDM in a virtual setting. The CFIR-ERIC tool highlighted the need for targeted educational meetings and materials to address the training and educational needs of both clinicians and patients for future iterations of this intervention.

The impact of different doses of oral iron supplementation during pregnancy: a pilot randomized trial

AbstractOral iron is first-line medication for iron deficiency anemia in pregnancy. We conducted a pilot randomized trial to investigate the impact of different doses of oral iron supplementation started early in pregnancy on women without anemia for 4 main outcomes: recruitment and protocol compliance, adherence, maintenance of maternal hemoglobin, and side effects. At antenatal clinic visits, participants were allocated to 1 of 3 trial arms in a 1:1:1 ratio: 200 mg ferrous sulfate daily, alternate days, or 3 times per week. The participants were followed to delivery. Baseline characteristics of 300 recruited participants were well matched between trial arms. The mean proportion of tablets taken as expected per participant was 82.5% overall (72.3%, 89.6%, and 84.5% for the daily, alternate days, and 3 times a week arm, respectively). There was a lower overall adherence rate in the daily arm (47%) than in the alternate days (62%) and the 3 times per week (61%) arms. A reduction in hemoglobin between randomization and 28 weeks’ gestation seemed smaller for the daily arm. A range of side effects were commonly reported at baseline before starting interventions and at later antenatal visits. Many side effects of iron overlapped with normal pregnancy symptoms. A daily iron dosing schedule might give the best opportunity for delivering an adequate iron load during pregnancy in women without anemia. Further randomized trials powered on clinical outcomes are needed to establish the clinical effectiveness of oral iron supplementation to prevent iron deficiency anemia. This study was registered (#ISRCTN12911644).

Influence of grandchildren on COVID-19 vaccination uptake among older adults in China: a parallel-group, cluster-randomized controlled trial.

The uptake of COVID-19 booster vaccination among older adults in China is suboptimal. Here, we report the results of a parallel-group cluster-randomized controlled trial evaluating the efficacy of promoting COVID-19 booster vaccination among grandparents (≥60 years) through a health education intervention delivered to their grandchildren (aged ≥16 years) in a Chinese cohort (Chinese Clinical Trial Registry: ChiCTR2200063240 ). The primary outcome was the uptake rate of COVID-19 booster dose among grandparents. Secondary outcomes include grandparents' attitude and intention to get a COVID-19 booster dose. A total of 202 college students were randomized 1:1 to either the intervention arm of web-based health education and 14 daily reminders (n = 188 grandparents) or control arm (n = 187 grandparents) and reported their grandparents' COVID-19 booster vaccination status at baseline and 21 days. Grandparents in the intervention arm were more likely to receive COVID-19 booster vaccination compared to control cohort (intervention, 30.6%; control, 16.9%; risk ratio = 2.00 (95% CI, 1.09 to 3.66)). Grandparents in the intervention arm also had greater attitude change (β = 0.28 (95% CI, 0.04 to 0.52)) and intention change (β = 0.32 (95% CI, 0.12 to 0.52)) to receive a COVID-19 booster dose. Our results show that an educational intervention targeting college students increased COVID-19 booster vaccination uptake among grandparents in China.

Movement Diversity and Complexity Increase as Arm Impairment Decreases After Stroke: Quality of Movement Experience as a Possible Target for Wearable Feedback.

Upper extremity (UE) impairment is common after stroke resulting in reduced arm use in daily life. A few studies have examined the use of wearable feedback of the quantity of arm movement to promote recovery, but with limited success. We posit that it may be more effective to encourage an increase in beneficial patterns of movement practice - i.e. the overall quality of the movement experience - rather than simply the overall amount of movement. As a first step toward testing this idea, here we sought to identify statistical features of the distributions of daily arm movements that become more prominent as arm impairment decreases, based on data obtained from a wrist IMU worn by 22 chronic stroke participants during their day. We identified several measures that increased as UE Fugl-Meyer (UEFM) score increased: the fraction of movements achieved at a higher speed, forearm postural diversity (quantified by kurtosis of the tilt-angle), and forearm postural complexity (quantified by sample entropy of tilt angle). Dividing participants into severe, moderate, and mild impairment groups, we found that forearm postural diversity and complexity were best able to distinguish the groups (Cohen's D =1.1, and 0.99, respectively) and were also the best subset of predictors for UEFM score. Based on these findings coupled with theories of motor learning that emphasize the importance of variety and challenge in practice, we suggest that using these measures of diversity and complexity in wearable rehabilitation could provide a basis to test whether the quality of the daily movement experience is therapeutic.

The feasibility, acceptability, and preliminary impact of real-time monitors and SMS on tuberculosis medication adherence in southwestern Uganda: Findings from a mixed methods pilot randomized controlled trial.

We conducted a pilot randomized controlled trial among patients initiating treatment for drug-sensitive tuberculosis (TB). Participants received real-time electronic adherence monitors and were randomized (1:1:1) to: (i) daily SMS (reminders to TB patients and notifications to social supporters sent daily for 3 months, then triggered by late or missed dosing for 3 months); (ii) weekly SMS (reminders to TB patients and notifications to social supporters sent weekly for 3 months, then triggered by late or missed dosing for 3 months); or (iii) control (no SMS). Feasibility was mainly verified by the technical function of the intervention at Month 6. The primary outcome was percent adherence as ascertained by the real time monitor. Quantitative feasibility/acceptability data were summarized descriptively. Percentage adherence and adherence patterns were assessed and compared by linear regression models. Qualitative acceptability data was collected through interviews and analyzed using content analysis. Among 63 participants, the median age was 35 years, 75% had no regular income, and 84% were living with HIV. Feasibility was demonstrated as most of the daily [1913/2395 (80%)] and weekly [631/872 (72%)] SMS reminders to TB patients were sent successfully. Also, most of the daily [1577/2395 (66%)] and weekly [740/872 (85%)] SMS notifications to social supporters and adherence data (96%) were sent successfully. Challenges included TB status disclosure, and financial constraints. All patients perceived the intervention to be useful in reminding and motivating them to take medication. Median adherence (IQR) in the daily SMS, weekly SMS, and control arms was 96.1% (84.8, 98.0), 92.5% (80.6, 96.3), and 92.2% (56.3, 97.8), respectively; however, differences between the intervention and control arms were not statistically significant. Real-time monitoring linked to SMS was feasible and acceptable and may have improved TB medication adherence. Larger studies are needed to further assess impact on adherence and clinical outcomes. Trial registration. ClinicalTrials.gov registration number: NCT03800888. https://ichgcp.net/clinical-trials-registry/NCT03800888.

P-007 A Four Arm Prospective Randomized Control Trial to Investigate the Role of Advance Sperm Selection Techniques for Raised Sperm DNA Fragmentation Index

Abstract Study question Role of Testicular Sperm Aspiration (TESA), Magnetic Activated Cell Sorting (MACS), Microfluidics & Daily ejaculation, to reduce raised Sperm DNA Fragmentation Index (SDF) & evaluate impact on outcomes? Summary answer Amongst the advance sperm selection methods, Microfluidic sperm sorting seems to significantly reduce the SDF and offer the best reproductive outcomes What is known already Raised SDF is known to affect the reproductive outcomes of a couple. There are various sperm processing methods/interventions shown to reduce the sperm DNA fragmentation, but their effectiveness to optimize reproductive outcomes is still debatabl. Study design, size, duration RCT approved by the Institutional Ethical Committee. IEC No.:1312/Inst/TG/2019. Couples undergoing IVF with raised SDF were randomized into four arms by computer generated randomized numbers from October 2019 to May 2022 (n = 466). Of those 373 patients recruited to, TESA (n = 129), MACS (n = 92), Microfluidics (n = 116) Daily ejaculation (n = 36) . Males with SDF > 25% & Age 25-40 yrs were included. Women>37 yrs, BMI >30 and men with Smoking, Binge alcohol, varicocele excluded. Couples with one failed IVF were offered SDF. SDF>25%was considered raised and were included in study. Participants/materials, setting, methods After Oocyte Pick Up (OPU), sample processed for ICSI and was sent for post intervention SDF. TESA done as per SOP of clinic. MACS & Microfluidics done as per instruction from manufacturer. Daily ejaculate group, patient ejaculated daily for 1week prior to OPU and at OPU, fresh ejaculate processed through density gradient. Men with high SDF, after randomization were subjected to OPU, ICSI, Blastocyst Culture, Freeze all policy and Frozen Embryo Transfer with 2blastocysts Main results and the role of chance Primary outcome-magnitude of reduction in SDF post intervention Secondary outcomes – Blastocyst Rate (BR), Implantation rates (IR), Live birth (LBR)Mean of SDF on Raw Semen Sample Vs Post Intervention Sample: TESA – 44% Vs 25.75% Microfluidics - 34.4% Vs 9.8% (p < 0.05; Significant) MACS – 32.2% Vs 27.95% Daily Ejaculation 39.37% Vs 19.66% Microfluidics seem to be beneficial intervention in significantly reducing the SDF. MACS seemed to have offered the least reduction of SDF. BR: This was comparable between all groups with no statistical significance Reproductive Outcomes for TESA, Microfluidics, MACS & Daily ejaculation: IR – 39.3% Vs 57.27% Vs 46.4% Vs 61% (p = 0.1) LBR – 60% VS 65% Vs 64% Vs 61% (p = 0.41) Miscarriage Rates and Multiple Pregnancy rates were comparable between the groups and statistically not significant. We observe that microfluidics was the best sperm processing method as it significantly reduced the DFI and had the best reproductive outcomes. It is noninvasive and can be done easily. Even though there was no statistical significance, Daily ejaculation yielded equivocal outcomes than the other 3 groups. Considering the ease, cost effectiveness and optimal reproductive outcomes Daily Ejaculation can also be offered to patients with raised SDF. Though TESA had acceptable outcomes, considering its invasiveness adequate counselling is warranted. Outcomes for MACS were guarded and be suggested with caution. Limitations, reasons for caution The sample size is small in the daily ejaculate arm as there were many dropouts. The unequal size of the arms would affect the results. So, we are continuing the randomization and intend to look into the results with equal size of the arms in the future Wider implications of the findings Published literature has shown raised SDF to be detrimental to reproductive outcomes. There is an urgent need for an efficient intervention which is safe, economical, easy to use and offers the best reproductive outcomes. Daily ejaculation, a traditional concept which is cost effective needs due consideration over other techniques. Trial registration number CTRI. Trial No.: REF/2021/05/043439

Indirect causal path from motor function to quality of life through daily use of the affected arm poststroke after task-specific training: a longitudinal mediation analysis

Purpose Task-specific training generally targets motor function, with the ultimate goal of improving quality of life (QoL). This study aimed to determine whether motor function indirectly affects QoL through daily use of the affected arm and activities of daily living (ADL) in patients with chronic stroke. Methods This was a retrospective cohort study of 155 patients who received training for 90–120 min/session, 3–5 sessions/week, for 4–6 weeks. The training involved specific mirror or robot-assisted therapy, followed by functional task practice for 15–30 min in each session. Patients were assessed before and after the intervention. Results At both pre-test and post-test, significant indirect effects of motor function on QoL through daily use of the affect arm and ADL were observed (β = 0.087–0.124). When the change scores of the measures between the pre-test and post-test were used, significant mediating effects of daily arm use on the relationship between motor function and QoL were identified (β = 0.094–0.103). Conclusions Enhanced motor function after intervention may lead to an increase in arm use for daily activities and subsequently result in an improvement in QoL. These results highlight the critical role of daily arm use in task-specific training aimed at improving QoL. IMPLICATIONS FOR REHABILITATION Task-specific training may improve motor function, daily arm use, activities of daily living, and quality of life in patients with mild-to-moderate arm hemiparesis. To improve quality of life in task-specific training, clinicians may work in sequence from motor function to daily arm use and then to activities of daily living. Emphasizing the use of the affected arm in daily life is critical to improve quality of life in task-specific training.

Validity of the short musculoskeletal function assessment questionnaire in patients with a spine fracture

PurposeThe aim of this study was to validate the use of the Short Musculoskeletal Function Assessment (SMFA) questionnaire in patients with a spine fracture.MethodsCross-sectional cohort of individuals that had sustained a spine fracture (C1-L5) one year earlier. Patients were asked to fill out SMFA, Oswestry Disability Index (ODI), EQ-5D-3L and EQ-VAS. Spearman’s rank correlation coefficient (rho) was used to assess convergent validity for each patient-reported outcome measure (PROM). Bland–Altman plots were used to assess PROM agreement.Results82 patients completed all questionnaires. The correlations between SMFA Dysfunction and Bother indices and ODI were 0.89 and 0.86, with EQ-5D-3L index 0.89 and 0.80, and with EQ-VAS 0.80 and 0.73, respectively. The correlation for separate categories of the SMFA dysfunction index (daily activities, emotional status, arm and hand function, mobility) ranged between 0.71–0.87 for ODI, 0.72–0.84 for EQ-5D-3L index, and 0.67–0.77 for EQ-VAS. A selection of the ten items of SMFA that had the highest correlations with ODI resulted in a correlation of 0.91. The agreements between SMFA indices and ODI in Bland–Altman plots were good with small differential biases and minimal proportional biases, but worse for SMFA and EQ-5D-3L index and EQ-VAS.ConclusionThe SMFA indices are highly correlated with ODI in patients with a spine fracture. The Dysfunction index and Bother index, or selected SMFA items, may be used to assess outcome in patients with spine fractures as an alternative to ODI.

Alternate day versus daily oral iron for treatment of iron deficiency anemia: a randomized controlled trial

Oral iron is the mainstay of treating iron deficiency anemia. Recent studies indicate better fractional iron absorption with alternate day supplementation. However, the optimal supplementation strategy is unclear. We compared effectiveness of daily versus alternate day supplementation of oral iron for treatment of iron deficiency anemia. This double blind, active control, randomized controlled trial was conducted on two hundred adults having hemoglobin 10 g/dL or less with microcytic hypochromic anemia and/or serum ferritin below 50 ng/mL. They were randomized to receive either two Ferrous sulfate tablets containing 60 mg elemental iron (120 mg total) on alternate days or single tablet of 60 mg elemental iron daily for 8 weeks. Primary outcome was mean change in hemoglobin at week 8 from baseline. Mean hemoglobin was 6.53 (± 1.89) and 6.68 (± 1.89) g/dL in the alternate day and daily arms respectively. Mean change in hemoglobin was + 1.05 ± 1.34 g/dL in alternate day arm and + 1.36 ± 1.51 g/dL in daily arm (p = 0.47) at week 8. There were no statistically significant differences between the arms with respect to any secondary outcome. There is no significant difference between alternate day and daily iron administration in improving hemoglobin. Randomized controlled trials enrolling more participants for longer periods of supplementation and evaluating clinically relevant outcomes like change in hemoglobin may be useful in identifying the ideal dosing strategy.Trial Registration: Clinical Trial Registry of India (CTRI/2019/01/017169).

Comparison Between Weekly vs Daily Dosing L-thyroxine for the Treatment of Hypothyroidism in Ramadan – A Pilot Randomized Controlled Trial

Introduction: Muslims find it difficult to take L-thyroxine on empty stomach during Sahur. Furthermore, physiological changes during Ramadan alter thyroid hormones level. Objective: To compare the efficacy, safety and patient’s preference of weekly vs daily dosing of L-thyroxine in Ramadan. Method: This is a pilot randomized open-label controlled trial among hypothyroid patients during Ramadan 2017-2018. Patients were randomized into weekly and daily arm. Weekly arm took 7x their usual L-thyroxine dose at least 30 minutes pre-sahur once a week while daily arm took their usual daily dose at least 2 hours after the last meal before bed. Thyroid hormones, lipid profile, cardiac parameters, cognitive and psychological function were assessed at baseline and at week 4. Cardiac reassessment was done within 24hrs after weekly dosing at week 2. Results: Eighteen patients were randomized into weekly and daily arm. Majority (66.7%) were hypothyroid secondary to radioiodine therapy. At the end of study, there were no significant changes of thyroid hormones level for weekly arm. However there was significant increment of TSH observed in daily arm [TSH w0 1.8(0.23,5.57) vs w4 3.65(0.45,16.1);p =0.011]. In terms of toxicities, there were no hyperthyroid or cardiac toxicities observed despite the significant increment of fT4 within 24hours of weekly dosing [fT4 w0 13.21(8.19,14.63) vs w2 17.43(12.38,22.55);p=0.011]. All patients were euthyroid and had no side effects. Majority (83.3%) of patients preferred weekly dosing during Ramadan. Conclusion: Weekly levothyroxine dosing during Ramadan appeared to be safe, efficient and the most preferred dosing method.

Characterizing HIV-Preventive, Plasma Tenofovir Concentrations-A Pooled Participant-level Data Analysis From Human Immunodeficiency Virus Preexposure Prophylaxis Clinical Trials.

Daily dosing of tenofovir disoproxil fumarate, with or without emtricitabine, has high efficacy in preventing human immunodeficiency virus (HIV) infection when individuals are adherent. The target protective plasma concentration of tenofovir (TFV), however, is not fully understood. The aim of this study is to estimate the protective TFV plasma concentration. Participant data from TFV-based daily oral and topical active arms of phase 3 trials (iPrEx, VOICE, and Partners PrEP) were pooled (n = 2950). Individual specific risk scores (low and high risk) of acquiring HIV, based on an earlier placebo analysis, were created. Longitudinal TFV pharmacokinetics (PK), HIV outcome, individual risk scores and the effect of sex at birth data were integrated and analyzed using non-linear mixed effects models. Around 50% of the individuals were estimated to be adherent, which differed from self-reported adherence (∼90%) and large variation between longitudinal adherence patterns were identified. Following oral administration, the estimated protective TFV trough concentration was substantially higher in high-risk females (45.8 ng/mL) compared with high-risk males (16.1 ng/mL) and to low-risk individuals (∼7.5 ng/mL). Dosing simulations indicated that high-risk women require full adherence to maintain protective levels. Using the largest PK-HIV outcome database to date, we developed a population adherence-PK-risk-outcome model. Our results indicate that high-risk females need higher levels of plasma TFV to achieve HIV protection compared with males. HIV protection exceeds 90% in all populations if daily adherence is achieved.

Moderation of buprenorphine therapy for cocaine dependence efficacy by variation of the Prodynorphin gene.

The aim of this secondary analysis was to identify prodynorphin (PDYN) genetic markers moderating the therapeutic response to treatment of cocaine dependence with buprenorphine/naloxone (Suboxone®; BUP). Cocaine-dependent participants (N = 302) were randomly assigned to a platform of injectable, extended-release naltrexone (XR-NTX) and one of three daily medication arms: 4mg BUP (BUP4), 16mg BUP (BUP16), or placebo (PLB) for 8weeks (Parent Trial Registration: Protocol ID: NIDA-CTN-0048, Clinical Trials.gov ID: NCT01402492). DNA was obtained from 277 participants. Treatment response was determined from weeks 3 to 7 over each 1-week period by the number of cocaine-positive urines per total possible urines. In the cross-ancestry group, the PLB group had more cocaine-positive urines than the BUP16 group (P = 0.0021). The interactions of genetic variant × treatment were observed in the rs1022563 A-allele carrier group where the BUP16 group (N = 35) had fewer cocaine-positive urines (P = 0.0006) than did the PLB group (N = 26) and in the rs1997794 A-allele carrier group where the BUP16 group (N = 49) had fewer cocaine-positive urines (P = 0.0003) than did the PLB group (N = 58). No difference was observed in the rs1022563 GG or rs1997794 GG genotype groups between the BUP16 and PLB groups. In the African American-ancestry subgroup, only the rs1022563 A-allele carrier group was associated with treatment response. These results suggest that PDYN variants may identify patients who are best suited to treatment with XR-NTX plus buprenorphine for cocaine use disorder pharmacotherapy.

HIV-1 Nucleic Acids Identify Rectal HIV Exposures in Self-Collected Rectal Swabs, Whereas Y-Chromosome Single Tandem Repeat Mixtures Are Not Reliable Biomarkers of Condomless Receptive Anal Intercourse.

To focus interventions, biomarkers of HIV-1 exposure could help in identifying subpopulations at highest risk of acquisition. We assessed whether Y-chromosome single tandem repeat (YSTR) mixtures obtained from rectal swabs could serve as a biomarker of condomless receptive anal intercourse (CRAI) among men who have sex with men and transgender women and evaluated the feasibility of detecting HIV-1 virions to assess exposures. Twenty-nine sexually active HIV-seronegative men who have sex with men and one transgender woman from New York City answered on-site and mobile app sexual behavior questionnaires. They were randomized to collecting self-administered rectal swabs every morning or after receptive anal intercourse (RAI). YSTR profiles were assessed from blood sample and swabs; HIV-1 exposure was measured by conducting quantitative polymerase chain reaction in swabs. After 2 months, the daily mobile survey had 135%-201% more instances of anal sex acts and 170%-193% more RAI than on-site surveys. Daily mobile reporting had 11%-35% less CRAI events than those reported on-site (Pdaily = 0.001; Pper-sex = 0.047). The daily swabbing arm reported less RAI (P < 0.001) and CRAI (P < 0.038) and had 2.95 lower odds of detecting YSTR mixtures (P = 0.021) than the per-sex-event arm. Surprisingly, YSTR detection was not significantly modified by report of bowel movements and lubricant, enema, or condom use. No participant became HIV-1 infected, yet HIV-1 total nucleic acids were detected in 6 independent episodes of CRAI in 2 participants taking pre-exposure prophylaxis. YSTR mixtures demonstrated 80% specificity but only 30% sensitivity as a biomarker of CRAI in self-collected rectal swabs. However, detection of HIV-1 exposures in self-collected swabs may help in identifying those needing further HIV risk reduction strategies.

Whole-Body Movements Increase Arm Use Outcomes of Wrist-Worn Accelerometers in Stroke Patients

Wrist-worn accelerometers are often applied to measure arm use after stroke. They measure arm movements during all activities, including whole-body movements, such as walking. Whole-body movements may influence clinimetric properties of arm use measurements—however, this has not yet been examined. This study investigates to what extent arm use measurements with wrist-worn accelerometers are affected by whole-body movements. Assuming that arm movements during whole-body movements are non-functional, we quantify the effect of whole-body movements by comparing two methods: Arm use measured with wrist-worn accelerometers during all whole-body postures and movements (P&M method), and during sitting/standing only (sit/stand method). We have performed a longitudinal observational cohort study with measurements in 33 stroke patients during weeks 3, 12, and 26 poststroke. The P&M method shows higher daily paretic arm use outcomes than the sit/stand method (p < 0.001), the mean difference increased from 31% at week three to 41% at week 26 (p < 0.001). Differences in daily paretic arm use between methods are strongly related to daily walking time (r = 0.83–0.92). Changes in the difference between methods are strongly related to changes in daily walking time (r = 0.89). We show that not correcting arm use measurements for whole-body movements substantially increases arm use outcomes, thereby threatening the validity of arm use outcomes and measured arm use changes.

Application and Reliability of Accelerometer-Based Arm Use Intensities in the Free-Living Environment for Manual Wheelchair Users and Able-Bodied Individuals.

Arm use in manual wheelchair (MWC) users is characterized by a combination of overuse and a sedentary lifestyle. This study aimed to describe the percentage of daily time MWC users and able-bodied individuals spend in each arm use intensity level utilizing accelerometers. Arm use intensity levels of the upper arms were defined as stationary, low, mid, and high from the signal magnitude area (SMA) of the segment accelerations based on in-lab MWC activities performed by eight MWC users. Accelerometry data were collected in the free-living environments from forty MWC users and 40 sex- and age-matched able-bodied individuals. The SMA intensity levels were applied to the free-living data and the percentage of time spent in each level was calculated. The SMA intensity levels were defined as, stationary: ≤0.67 g, low: 0.671–3.27 g, mid: 3.27–5.87 g, and high: >5.871 g. The dominant arm of both MWC users and able-bodied individuals was stationary for most of the day and less than one percent of the day was spent in high intensity arm activities. Increased MWC user age correlated with increased stationary arm time (R = 0.368, p = 0.019). Five and eight days of data are needed from MWC users and able-bodied individuals, respectively, to achieve reliable representation of their daily arm use intensities.

Vitamin C supplementation improves blood pressure and oxidative stress after acute exercise in patients with poorly controlled type 2 diabetes mellitus: A randomized, placebo-controlled, cross-over study.

This study aimed to assess the effect of Vitamin C on blood pressure (BP), and subsequently on oxidative stress and nitric oxide (NO) release, following the low-intensity exercise in the patients. This study included 24 patients with type 2 diabetes mellitus (T2D) (age, 53 ± 7 years; hemoglobin A1c, 10.1% ± 0.9%) randomized into two 6-week daily arms based on the consumption of either placebo or 1000 mg Vitamin C. The crossover trial occurred after a 6-week washout. Before and after both supplementation arms, all patients performed cycling exercise at 33% of peak oxygen consumption for 20 min. BP was measured before, immediately, and 60 min after the exercise. Blood samples were drawn immediately before and after the exercise to determine plasma ascorbate, malondialdehyde (MDA), F2-isoprostanes (F2-IsoPs), and NO concentrations. Data showed significant lower BP in the Vitamin C arm when compared with the placebo arm (systolic BP [SBP] P < 0.001 at every time point, diastolic BP [DBP] P < 0.001 except at immediately after exercise, P < 0.05). Plasma ascorbate concentration (P < 0.05 at every time point) and plasma NO (at resting P < 0.001, immediately after exercise P < 0.05) were significantly increased in the Vitamin C arm than in the placebo arm. Plasma MDA (P < 0.05 at every time point) and F2-IsoPs (P < 0.05 at every time point) concentrations were significantly lower in the Vitamin C arm than in the placebo arm. In addition, data showed significantly lower SBP (P < 0.001 at every time point), DBP (P < 0.001 except at immediately after exercise P < 0.05), plasma MDA (P < 0.001 at every time point), and F2-IsoPs (P < 0.05 at every time point) at post-supplementation than at pre-supplementation. Besides, there were significantly higher plasma ascorbate (P < 0.05 at every time point) and NO (at rest P < 0.01, immediately after exercise P < 0.05) concentrations at post-supplementation than at pre-supplementation. This is in contrast to the placebo treatment arm which demonstrated no statistical difference in all outcomes throughout the experiment. This study suggests that 6-week Vitamin C supplementation decreased preexercise and postexercise BPs, possibly due to improved oxidative stress and NO release. However, exercise had no effect on any outcome measures.

632. A Randomized, Placebo-Controlled, Double-Blind, Clinical Trial Evaluating Two Dose Regimens of Rifaximin (550mg daily or twice-daily) for Chemoprophylaxis Against Travelers’ Diarrhea Among Deployed U.S. and U.K. Military Personnel (PREVENT TD)

BackgroundTravelers’ diarrhea (TD) is a leading threat to military readiness. Most trials of rifaximin chemoprophylaxis involve civilians or short-duration travel, whereas military travelers are exposed for longer periods at austere locations and are often physically taxed. We sought to assess efficacy of two regimens among military personnel deployed overseas.MethodsThis was a multi-site, double-blind, placebo-controlled trial of deployed military, randomized to placebo, rifaximin 550 mg daily, or rifaximin 550 mg twice-daily, for up to 42 days (1:1:1; 6 randomizations/block). Diaries were reviewed with subjects on return. Primary endpoint was time to first unformed stool (TFUS) in a TD episode. Other endpoints were assessed by intention to treat (ITT) and subgroups included incidence of any loose stool, meeting criteria for TD, safety, efficacy, adherence and impact to activity endpoints.Results343 subjects were included in the ITT population. All UK travelers deployed to a single-site in Kenya; US travelers mostly deployed to various Asia-Pacific locations. Of 73 (21.2%) subjects reporting diarrhea, 42 (57.5%) met TD criteria. Among rifaximin-treated subjects, 15.9% (n=17) reported diarrhea in the twice-daily arm, 20.7% (n=25) in the daily arm, vs. 27.0% (n=31) of placebo recipients; p=.04 and 0.26 respectively. TD was reported by 10.3% (n=11) and 10.7% (n=13) in the daily and twice-daily arms, vs. 15.7% (n=18) among placebo recipients; p=0.24 vs. 0.26 respectively. Among UK personnel, a twice-daily regimen vs. placebo resulted in significantly fewer TD episodes (1.6% vs. 11.9%; p=0.03). Adverse events were similar between groups.Table 1: Demographics, endpoints, and adverse events (Comparisons are across placebo vs. each dosing regimen. Intent-to-treat [ITT] population defined as subjects enrolled into the study, randomized, travelled and had follow-up. p-values calculated from chi-square or Fisher’s exact test [categorical variables] and Wilcoxon-Mann-Whitney test [continuous variables]. Analyses performed on SAS v9.4. BID: twice-daily) ConclusionThis is the first trial comparing two high-dose regimens of rifaximin prophylaxis in deployed personnel. Unlike prior reports, neither regimen was associated with an overall significant decrease in TD, potentially due to low overall TD incidence. However, the twice-daily regimen was associated with a numerically lower incidence of diarrheal stool, and in the UK subject group, there was a significant decrease of both TD and diarrheal stool. The impact of variability in regional TD risk, pathogen distribution and adherence in austere deployment environments on efficacy will be reviewed.Disclosures All Authors: No reported disclosures

Hand Focused Upper Extremity Rehabilitation in the Subacute Phase Post-stroke Using Interactive Virtual Environments.

Introduction: Innovative motor therapies have attempted to reduce upper extremity impairment after stroke but have not made substantial improvement as over 50% of people post-stroke continue to have sensorimotor deficits affecting their self-care and participation in daily activities. Intervention studies have focused on the role of increased dosing, however recent studies have indicated that timing of rehabilitation interventions may be as important as dosing and importantly, that dosing and timing interact in mediating effectiveness. This study is designed to empirically test dosing and timing.Methods and Analysis: In this single-blinded, interventional study, subjects will be stratified on two dimensions, impairment level (Fugl-Meyer Upper Extremity Assessment (FM) and presence or absence of Motor Evoked Potentials (MEPs) as follows; (1) Severe, FM score 10–19, MEP+, (2) Severe, FM score 10–19, MEP–, (3) Moderate, FM score 20–49, MEP+, (4) Moderate, FM score 20–49, MEP–. Subjects not eligible for TMS will be assigned to either group 2 (if severe) or group 3 (if moderate). Stratified block randomization will then be used to achieve a balanced assignment. Early Robotic/VR Therapy (EVR) experimental group will receive in-patient usual care therapy plus an extra 10 h of intensive upper extremity therapy focusing on the hand using robotically facilitated rehabilitation interventions presented in virtual environments and initiated 5–30 days post-stroke. Delayed Robotic/VR Therapy (DVR) experimental group will receive the same intervention but initiated 30–60 days post-stroke. Dose-matched usual care group (DMUC) will receive an extra 10 h of usual care initiated 5–30 days post-stroke. Usual Care Group (UC) will receive the usual amount of physical/occupational therapy.Outcomes: There are clinical, neurophysiological, and kinematic/kinetic measures, plus measures of daily arm use and quality of life. Primary outcome is the Action Research Arm Test (ARAT) measured at 4 months post-stroke.Discussion: Outcome measures will be assessed to determine whether there is an early time period in which rehabilitation will be most effective, and whether there is a difference in the recapture of premorbid patterns of movement vs. the development of an efficient, but compensatory movement strategy.Ethical Considerations: The IRBs of New Jersey Institute of Technology, Rutgers University, Northeastern University, and Kessler Foundation reviewed and approved all study protocols. Study was registered in https://ClinicalTrials.gov (NCT03569059) prior to recruitment. Dissemination will include submission to peer-reviewed journals and professional presentations.

Tolerability of daily intermittent or continuous short-arm centrifugation during 60-day 6o head down bed rest (AGBRESA study).

Artificial gravity through short-arm centrifugation has potential as a multi-system countermeasure for deconditioning and cranial fluid shifts that may underlie ocular issues in microgravity. However, the optimal short-arm centrifugation protocol that is effective whilst remaining tolerable has yet to be determined. Given that exposure to centrifugation is associated with presyncope and syncope and in addition motion sickness an intermittent protocol has been suggested to be more tolerable. Therefore, we assessed cardiovascular loading and subjective tolerability of daily short arm centrifugation with either an intermittent or a continuous protocol during long-term head-down bed rest as model for microgravity exposure in a mixed sex cohort. During the Artificial Gravity Bed Rest with European Space Agency (AGBRESA) 60 day 6° head down tilt bed rest study we compared the tolerability of daily +1 Gz exposure at the center of mass centrifugation, either performed continuously for 30 minutes, or intermittedly (6 x 5 minutes). Heart rate and blood pressure were assessed daily during centrifugation along with post motion sickness scoring and rate of perceived exertion. During bed rest, 16 subjects (6 women, 10 men), underwent 960 centrifuge runs in total. Ten centrifuge runs had to be terminated prematurely, 8 continuous runs and 2 intermittent runs, mostly due to pre-syncopal symptoms and not motion sickness. All subjects were, however, able to resume centrifuge training on subsequent days. We conclude that both continuous and intermittent short-arm centrifugation protocols providing artificial gravity equivalent to +1 Gz at the center of mass is tolerable in terms of cardiovascular loading and motion sickness during long-term head down tilt bed rest. However, intermittent centrifugation appears marginally better tolerated, albeit differences appear minor.

Reference value for the six-minute peg board and ring test. A cross sectional study.

IntroductionIn our daily life, arm activities, whether supported or unsupported play a major role. Both simple and complex activities require the muscles, namely trapezius, pectoralis minor, scalene, and intercostals, to participate in arm positioning. These muscles also enact as the accessory respiratory muscles. Therefore, arm elevation increases the load on these muscles and they fail to perform dual activities, resulting in arm fatigue and a feeling of dyspnoea in healthy individuals as well as in chronic obstructive pulmonary disease patients. Various upper limb exercise tests were designed to measure this impairment, one of them being the six-minute peg board and ring test. The aim of the study is to derive a reference value for the six-minute peg board and ring test among healthy Indian population (Mangalore) from the age of 20-70 years of either gender. Also, to find a correlation among the number of rings and body mass index, arm length, arm and forearm circumference, the strength of shoulder and elbow flexors-extensors, grip strength of both sides and level of physical activity.MethodsParticipants performed two tests, thirty minutes apart. They were asked to load as many rings as possible in 6 minutes. Arm length, arm and forearm circumference were measured with a measuring tape. Shoulder and elbow flexors-extensors were assessed using a handheld push-pull dynamometer. Grip strength was measured with the Jamar hand-held dynamometer. Level of physical activity was assessed using International Physical Activity Questionnairelong form.ResultsThe samples consisted of 450 healthy individuals between the age of 20-70 years. Reference values for each age group for both genders were reported. We found that age was correlated with the six-minute peg board and ring test score (p<0.05). We also found a correlation between the strength variables and the test results (p=0.001). However, no correlation was found between the arm length, arm and forearm circumference and the level of physical activity with the number of rings.ConclusionIn this study, we derived a reference value for the six-minute peg board and ring test. There was a correlation among age, strength variables and the number of rings.