Standard Rehabilitation Care Research Articles

Complementary, integrative, and standard rehabilitative therapies in a military population with chronic predominantly musculoskeletal pain: a pragmatic clinical trial with SMART design.

There is growing acceptance for combining complementary and integrative health (CIH) therapies with standard rehabilitative care (SRC) for chronic pain management, yet little evidence on the best sequence of therapies. We investigated whether starting with CIH therapies or SRC is more effective in reducing pain impact. Participants were 280 service members with predominantly (88%) musculoskeletal chronic pain referred to an interdisciplinary pain management center who were randomized to a twice weekly program of either CIH therapies (n = 140) or SRC (n = 140) for the 3-week first stage of treatment. The composition of a second 3-week treatment stage depended upon response to the first stage. The primary outcome measure was the impact score (range 8-50) from the NIH Task Force on Research Standards for Chronic Low-Back Pain. Outcomes were measured after 3 and 6 weeks of treatment and at 3- and 6-month follow-ups. Most participants were men (76.8%) and mean age was 34.7 years (SD 8.0). At end of stage 1, pain impact decreased significantly more in the CIH group (29.8 points [SD 7.2] at baseline to 26.3 points [SD 7.9], change of -3.3 points [95% confidence interval, -4.2 to -2.5]) than in the SRC group (30.8 [SD 7.6] to 29.4 [SD 7.8], change of -0.9 points [95% confidence interval, -1.8 to -0.1]; P < 0.001). No significant between-group differences were observed after 6 weeks of treatment nor at 3- or 6-month follow-ups. Complementary and integrative health therapies may provide earlier improvement in pain impact than SRC, but this difference is not sustained.

Fatigue and Sleep-related Impairment as Predictors of the Effect of Nonpharmacological Therapies for Active duty Service Members With Chronic Pain: A Secondary Analysis of a Pragmatic Randomized Clinical Trial.

First-line treatments for chronic pain include selected complementary and integrative health therapies, including spinal manipulation, acupuncture, yoga, and massage; and standard rehabilitative care, including physical and occupational therapies. This study aimed to uncover critical factors that contribute to pain impact and the effectiveness of complementary and integrative health therapies and standard rehabilitative care among people with chronic pain, with a focus on the role of sleep-related impairment. We conducted a secondary analysis of data from a pragmatic randomized clinical trial of 280 U.S. active duty service members with chronic pain. Our study's multiple mediation analysis examined the indirect effect of complementary and integrative health therapies on pain impact through fatigue (β = - 0.43; 95% CI, -0.99 to -0.07). When stratified by sleep-related impairment, participants with T scores above the median of 62 demonstrated a significant negative indirect effect of complementary and integrative health therapies through fatigue (β = - 0.80; 95% CI, -2.31 to -0.14). This negative indirect effect was not significant for participants with sleep-related impairment T scores below the median (β = - 0.64; 95% CI, -1.48 to 0.07). These findings suggest that complementary and integrative health therapies are particularly effective in reducing pain impact for individuals with higher levels of sleep-related impairment, and that the effect of complementary and integrative health therapies is supported primarily by reducing fatigue.

Poster 328: Effect of Knee Aspiration prior to ACL Reconstruction Surgery on Subsequent Surgery: A Randomized Clinical Trial

Objectives: The traumatic effusion associated with an acute anterior cruciate ligament (ACL) rupture contains pro-inflammatory cytokines, chemokines and matrix degrading enzymes. Aspiration of the effusion may help reduce the burden of joint inflammation. However, the short and mid-term implications of routine aspiration have not been well documented. The primary objective of this prospective, randomized control trial is to determine whether routine pre-operative aspiration upon presentation to the orthopaedic clinic impacts (a) all-cause re-operation rate in patients undergoing ACL reconstruction (ACLr) and, more specifically, (b) rate of surgical debridement for postoperative arthrofibrosis, a common clinical sequela of ACLr. Methods: Eligible patients presented to a single, academic sports surgeon with an acute ACL rupture and were clinically indicated for ACLr. Both sexes were included in this study. Exclusion criteria included pre-existing osteoarthritis (Kellgren-Lawrence grade 3 or greater), focal chondral injury (International Cartilage Repair Society grade 3 or higher), concurrent ipsilateral extra-articular injury, history of contralateral knee injury, or age greater than 62 years. Patients were randomized to either routine preoperative care or in-office aspiration of their traumatic effusion upon initial presentation. Patients underwent routine diagnostic arthroscopy at the time of ACLr to evaluate for concurrent chondral or meniscal pathology. Patients underwent standard postoperative rehabilitation and follow-up care. Results: Eighty-seven patients were enrolled in this study, with 46 (53%) patients randomized to and undergoing preoperative aspiration (Table 1). At a mean follow-up of 2.56 years, 14 patients (16%) underwent re-operation for any reason and 10 (11.5%) patients underwent debridement of arthrofibrosis (Table 2). Preoperative aspiration was not significantly associated with a decreased rate of arthrofibrosis (Figure 1) or re-operation (Figure 2). However, it was significantly associated with a longer time to debridement for arthrofibrosis (125 days vs 457 days, p = 0.0029). Conclusions: Preoperative aspiration does not modify rates of subsequent surgery following ACLr. In patients who develop arthrofibrosis after ACLr, preoperative aspiration is associated with a delay in the development of arthrofibrosis. This could be due to a decrease in burden of intraarticular inflammation after aspiration. Further study is needed to assess why aspiration delays the onset of arthrofibrosis and whether aspiration impacts long-term outcomes such as the development of post-traumatic OA.

Standardized In-Bed Mobility Protocol to Increase Functional Outcomes in Pediatric Intensive Care Unit: A Pilot Randomized Controlled Trial

AbstractThe primary aim of this study is to determine whether a standardized in-bed mobility protocol involving an in-bed cycle ergometer in critically ill children increases functional outcomes as measured by the Functional Status Scale (FSS) and dynamometer measurements compared with patients participating in standard rehabilitation care. The secondary aim was to compare hospital length of stay (HLOS) between the two groups. This pilot randomized controlled trial (RCT) was conducted between April 2021 and December 2022. Eligible patients were randomized to the intervention group (up to 30 minutes of daily in-bed cycle ergometer use) or the control group (standardized rehabilitation care). During the study duration, 30 patients were randomized (13 in the control group and 17 in the intervention group). The difference in whole-body muscle strength measurements (enrollment vs. completion of study) was higher in the experimental group (3.68 lbs.) compared with the control group (1.5 lbs.). However, the difference between groups was not statistically significant (p = 0.18). Both the intervention group and the control group showed similar significant improvements in the FSS scores throughout the therapy, with no difference between the two groups. There was a significant positive correlation between exercise time and change in muscle strength (r = 0.75, p = 0.002). No difference in HLOS was detected in the study. Results from this pilot RCT suggest a trend toward benefits from using in-bed cycle ergometers. These devices may be an additional modality for preserving muscle function in critically ill children. Larger multicentric studies are needed for more conclusive evidence.

The effect of virtual reality spiritual emotional freedom technique (Vr-seft) therapy on anxiety and cortisol in drug patients in Makassar class I state detention center

Drug abuse is a global problem that is increasing every year. Various previous studies have described the magnitude of psychological disorders and the impact of drug use as quite serious. Nonpharmacological measures such as spiritual direction are stated to reduce anxiety and depression in drug treatment patients significantly. Virtual Reality Spiritual Emotional Freedom Technique (VR-SEFT) is designed based on SEFT theory applied to interactive visualization of virtual environments. This study aims to determine the effect of VR-SEFT therapy on anxiety and cortisol hormone levels in drug patients at Makassar Class I State Prison. This research employs a quasi-experimental methodology utilizing a control group design with both pre-test and post-test assessments. The analysis was carried out on 66 respondents who were divided into 2 groups, 33 intervention group respondents and 33 control groups in Makassar Class I State Detention Center selected using consecutive sampling. The intervention group given VR-SEFT was carried out for eight weeks with 24 meetings. Each intervention was 15-20 minutes, while the control group was assigned standard rehabilitation care. HRS-A measured fatigue in both groups, and the ELISA method measured cortisol hormone levels. The median values of anxiety and cortisol in both groups before SEFT therapy showed a tending score, but after treatment, it was known that the intervention group given VR-SEFT therapy experienced a significant decrease in anxiety scores (mean rank = 32.73) and cortisol (mean rank = 32.73) (p &lt; 0.05) compared to anxiety scores (mean rank = 48.11) and cortisol (mean rank = 34.27) in the control group. There is an effect of VR-SEFT on anxiety and cortisol hormone levels in drug patients at Makassar Class I State Detention Center.

DiSCIoser: unlocking recovery potential of arm sensorimotor functions after spinal cord injury by promoting activity-dependent brain plasticity by means of brain-computer interface technology: a randomized controlled trial to test efficacy

BackgroundTraumatic cervical spinal cord injury (SCI) results in reduced sensorimotor abilities that strongly impact on the achievement of daily living activities involving hand/arm function. Among several technology-based rehabilitative approaches, Brain-Computer Interfaces (BCIs) which enable the modulation of electroencephalographic sensorimotor rhythms, are promising tools to promote the recovery of hand function after SCI. The “DiSCIoser” study proposes a BCI-supported motor imagery (MI) training to engage the sensorimotor system and thus facilitate the neuroplasticity to eventually optimize upper limb sensorimotor functional recovery in patients with SCI during the subacute phase, at the peak of brain and spinal plasticity. To this purpose, we have designed a BCI system fully compatible with a clinical setting whose efficacy in improving hand sensorimotor function outcomes in patients with traumatic cervical SCI will be assessed and compared to the hand MI training not supported by BCI.MethodsThis randomized controlled trial will include 30 participants with traumatic cervical SCI in the subacute phase randomly assigned to 2 intervention groups: the BCI-assisted hand MI training and the hand MI training not supported by BCI. Both interventions are delivered (3 weekly sessions; 12 weeks) as add-on to standard rehabilitation care. A multidimensional assessment will be performed at: randomization/pre-intervention and post-intervention. Primary outcome measure is the Graded Redefined Assessment of Strength, Sensibility and Prehension (GRASSP) somatosensory sub-score. Secondary outcome measures include the motor and functional scores of the GRASSP and other clinical, neuropsychological, neurophysiological and neuroimaging measures.DiscussionWe expect the BCI-based intervention to promote meaningful cortical sensorimotor plasticity and eventually maximize recovery of arm functions in traumatic cervical subacute SCI. This study will generate a body of knowledge that is fundamental to drive optimization of BCI application in SCI as a top-down therapeutic intervention, thus beyond the canonical use of BCI as assistive tool.Trial registrationName of registry: DiSCIoser: improving arm sensorimotor functions after spinal cord injury via brain-computer interface training (DiSCIoser). Trial registration number: NCT05637775; registration date on the ClinicalTrial.gov platform: 05-12-2022.

Cognitive outcomes in patients treated with neuromuscular electrical stimulation after coronary artery bypass grafting.

Mechanisms of neurocognitive injury as post-operative sequelae of coronary artery bypass grafting (CABG) are not understood. The systemic inflammatory response to surgical stress causes skeletal muscle impairment, and this is also worsened by immobility. Since evidence supports a link between muscle vitality and neuroprotection, there is a need to understand the mechanisms by which promotion of muscle activity counteracts the deleterious effects of surgery on long-term cognition. We performed a clinical trial to test the hypothesis that adding neuromuscular electrical stimulation (NMES) to standard rehabilitation care in post-CABG patients promotes the maintenance of skeletal muscle strength and the expression of circulating neuroprotective myokines. We did not find higher serum levels of neuroprotective myokines, except for interleukin-6, nor better long-term cognitive performance in our intervention group. However, a greater increase in functional connectivity at brain magnetic resonance was seen between seed regions within the default mode, frontoparietal, salience, and sensorimotor networks in the NMES group. Regardless of the treatment protocol, patients with a Klotho increase 3 months after hospital discharge compared to baseline Klotho values showed better scores in delayed memory tests. We confirm the potential neuroprotective effect of Klotho in a clinical setting and for the first time post-CABG.

Cycling in primary progressive multiple sclerosis (CYPRO): study protocol for a randomized controlled superiority trial evaluating the effects of high-intensity interval training in persons with primary progressive multiple sclerosis

BackgroundPrimary progressive multiple sclerosis (PPMS) is the least prevalent multiple sclerosis (MS) phenotype. For persons with PPMS (pwPPMS), pharmacological treatment options are limited. As a complementary non-pharmacological treatment, endurance training improves the health-related quality of life (HRQoL), numerous MS symptoms, and MS-related performance impediments. High-intensity interval training (HIIT) has been shown to induce superior effects compared to moderate-intensity continuous training (MCT). As current evidence is based on MS samples with mixed phenotypes, generalizability to pwPPMS remains unclear.MethodsCYPRO is a parallel-group, single-center, and single-blind randomized controlled superiority trial evaluating the effects of HIIT compared to MCT in pwPPMS. Sixty-one pwPPMS are randomized (1:1) to perform volume-matched HIIT or MCT sessions on bicycle ergometers two to three times per week in addition to standard rehabilitative care during their three-week inpatient stay at Valens rehabilitation clinic, Switzerland. Standard rehabilitative care comprises endurance and strength training, physiotherapy, and occupational therapy. HIIT sessions include six 90-second intervals at 95% peak heart rate (HRpeak), interspersed by 90-second active breaks with unloaded pedaling, aimed to reach 60%HRpeak. MCT represents the standard treatment at Valens rehabilitation clinic and is performed as continuous cycling at 60%HRpeak for the duration of 26 minutes. The primary outcome is cardiorespiratory fitness, assessed as peak oxygen consumption (V̇O2peak) during cardiopulmonary exercise testing (CPET). Secondary outcomes include peak power output during CPET, walking capacity, cognitive performance, HRQoL, fatigue, anxiety and depressive symptoms, and blood-derived biomarkers (e.g., serum neurofilament light chain, glial fibrillary acidic protein, kynurenine pathway metabolites) related to MS pathophysiology. All outcomes are assessed at baseline and discharge after three weeks. Venous blood sampling is additionally performed immediately and two hours after the first HIIT or MCT session.DiscussionCYPRO will expand current knowledge on symptom management and rehabilitation in MS to the subpopulation of pwPPMS, and will contribute to the exploration of potential disease-modifying effects of endurance training in MS. The superiority design of CYPRO will allow deriving explicit recommendations on endurance training design in pwPPMS that can be readily translated into clinical practice.Trial registrationCYPRO has been prospectively registered at ClinicalTrials.gov on 8 February 2022 (NCT05229861).

The Role of Psychological Factors in Chronic Pain Treatment Outcomes in the Military

PurposeChronic pain treatment in the military includes complementary and integrative health (CIH) therapies that may affect psychological factors such as pain catastrophizing, chronic pain acceptance, pain self-efficacy, and patient activation. The unique roles that psychosocial factors play in how CIH approaches reduce pain are not clear. This study examined if a holistic pain management program improved pain outcomes through psychological mediators in service members with chronic pain. DesignSecondary analysis of a clinical trial. MethodsActive-duty service members (n = 210) were randomly assigned to a 3-week course of standard rehabilitative care or standard rehabilitative care combined with CIH therapies. Both treatments were followed by a 3-week functional restoration program. Study measures were completed pre- and post-treatment using the Military Health System's Pain Assessment Screening Tool and Outcomes Registry. Mediation analyses tested the indirect effects of the change in psychological factors before functional restoration on the change in pain impact (e.g., pain intensity, pain interference, functional status) after functional restoration. ResultsAll psychological factors except for chronic pain acceptance were related to improved pain impact (p<.05). Furthermore, a change in psychological factors prior to functional restoration was related to the change in pain impact after functional restoration. However, the addition of CIH therapies to standard rehabilitative care did not result in changes in pain outcomes mediated by the psychological factors. ConclusionsAlthough psychological factors were related to pain outcomes, the effect of CIH therapies on chronic pain did not occur via a change in the four psychological factors.

Uneven Treadmill Training for Rehabilitation of Lateral Ankle Sprains and Chronic Ankle Instability: Protocol for a Pragmatic Randomized Controlled Trial.

BackgroundLateral ankle sprains (LASs) are common injuries among military service members. Approximately 40% of individuals with an LAS progress to develop chronic ankle instability (CAI), a condition that results in substantial mechanical and neurophysiological impairment and activity limitation. Since proprioceptive and balance training improve functional outcomes and prevent secondary injury following LAS, they are recommended in clinical practice. Uneven treadmills are an innovative modality that challenge the sensorimotor system while performing an ecologically valid task simulating environments frequently encountered by service members with LAS and CAI.ObjectiveThe aim of this study is to evaluate whether the inclusion of uneven treadmill training in standard rehabilitation can improve clinical, functional, biomechanical, and patient-reported outcomes compared with the standard of care alone in service members with LAS and CAI. The prophylactic effects of treatment on secondary injury and identification of any contributing or mediating factors that influence outcomes following treatment will also be evaluated. We hypothesize that service members receiving uneven treadmill training will demonstrate greater improvements in clinical and instrumented measures of impairment, patient-reported function, and lower risk of injury recurrence than the control group immediately post and 18 months following treatment.MethodsA multisite, parallel randomized clinical trial will be performed among service members aged 18-49 years being treated for LAS and CAI in military treatment facilities in the United States. Participants randomly assigned and allocated to receive the experimental intervention will be provided up to 12 sessions of training on an uneven terrain treadmill over a 6-week treatment course to supplement standard rehabilitation care. Treatment intensity of the rehabilitation exercises and treadmill training will be progressed on the basis of patient-perceived intensity and treatment responses. Outcome measures will include patient-reported outcomes, functional assessments, performance measures, and biomechanical measures. Investigators collecting outcome measures will be blinded to treatment allocation. Reinjury rates and patient-reported outcomes of function will be tracked over 18 months following treatment.ResultsThe project was funded in September 2020. Patient recruitment began in November 2021, with 3 participants enrolled as of February 2022. Dissemination of the main study findings is anticipated in 2024.ConclusionsThis study will assess the impact of an innovative uneven-terrain treadmill on treatment outcomes in the rehabilitation of service members with LAS and CAI. The results of this study will be used to inform rehabilitation practices and to potentially improve functional outcomes and secondary prevention in this patient population.Trial RegistrationClinicalTrials.gov NCT04999904; https://clinicaltrials.gov/ct2/show/NCT04999904?term=NCT04999904International Registered Report Identifier (IRRID)DERR1-10.2196/38442

Cost Utility Analysis of Multidisciplinary Postacute Care for Stroke: A Prospective Six-Hospital Cohort Study.

BackgroundFew studies have compared the optimal duration and intensity of organized multidisciplinary neurological/rehabilitative care delivered in a regional/district hospital with the standard rehabilitative care delivered in the general neurology/rehabilitation ward of a medical center. This study measured functional outcomes and conducted cost-utility analysis of an organized multidisciplinary postacute care (PAC) project in secondary care compared with standard rehabilitative care delivered in tertiary care.MethodsThis prospective cohort study enrolled 1,476 patients who had a stroke between March 2014 and March 2018 and had a modified Rankin scale score of 2–4. After exact matching for age ± 1 year, sex, year of stroke diagnosis, nasogastric tube, and Foley catheter and propensity score matching for the other covariates, we obtained 120 patients receiving PAC (the PAC group) from four regional/district hospitals and 120 patients not receiving PAC (the non-PAC group) from two medical centers.ResultsAt baseline, the non-PAC group showed significantly better functional outcomes than the PAC group, including EuroQol-5 dimensions (EQ-5D), Mini-Mental State Examination (MMSE) and Barthel index (BI). During weeks 7–12 of rehabilitation, improvements in all functional outcomes were significantly larger in the PAC group (P < 0.001) except for Functional Oral Intake Scale (FOIS). Cost-utility analysis revealed that the PAC group had a significantly lower mean (± standard deviation) of direct medical costs (US$3,480 ± $1,758 vs. US$3,785 ± $3,840, P < 0.001) and a significantly higher average gain of quality-adjusted life years (0.1993 vs. 0.1233, P < 0.001). The PAC project was an economically “dominant” strategy.ConclusionsThe PAC project saved costs and significantly improved the functional outcomes of patients with stroke with slight to moderately severe disabilities. Randomized control trials are required to corroborate these results.

Use of Complementary and Integrative Health Therapies Before Intensive Functional Restoration in Active Duty Service Members with Chronic Pain.

Psychosocial factors are known to predict chronic pain, and the use of complementary and integrative health (CIH) therapies to address pain is emerging among the military population. However, conflicting results on pain outcomes warrant additional research. This study aimed to 1) evaluate the benefit of adding a CIH pain management program to standard rehabilitative care (SRC), as compared with SRC alone, as a precursor to an intensive functional restoration (FR) program; 2) identify factors that predict improvement in pain outcomes after treatment; and 3) determine the proportion of participants who experience a clinically meaningful response. Pragmatic randomized controlled clinical trial. Participants were randomized to a 3-week course of either SRC alone or SRC+CIH (stage 1), followed by a 3- to 6-week course of FR (stage 2). Active duty service members with chronic pain. Participants completed either SRC alone or SRC+CIH (stage 1), followed by a course of FR (stage 2). Patient-reported and provider-determined outcomes were collected at baseline, after stage 1, and after stage 2. A covariance pattern model with an unstructured residual covariance matrix was used to compare treatment arms while accounting for dependency due to repeated measurements. A total of 210 service members participated. Most were in the Army (82%) and were male (84%). Participants randomized to the SRC+CIH intervention had greater improvement in the pain impact score than did those in the SRC-alone group. Predictors of outcomes were baseline impact score, anger, depression, and educational status. This study found that military service members with the highest pain impact benefit the most from interdisciplinary pain care.

Fatigue and functional outcomes in cancer rehabilitation.

Cancer-related fatigue (CRF) is one of the most common symptoms experienced by oncology patients, though its impact on functional outcomes during inpatient rehabilitation is relatively unknown. The purpose of this study is to determine whether CRF severity on admission is related to functional gains following standard rehabilitation care in an inpatient oncology rehabilitation population. A retrospective cohort study was conducted within an inpatient oncology unit at a long-term acute care hospital. Seventy-six patients admitted to the hospital between April and December 2015 with an oncology diagnosis, planned discharge, and completed standardized assessments of CRF and functional ability were included in this study. Patients received standard interdisciplinary rehabilitation services including physical and occupational therapy. CRF was assessed on admission using the Brief Fatigue Inventory, and functional abilities were assessed on admission and discharge using the basic mobility and daily activity domains of the Activity Measure for Post-Acute Care inpatient short forms (AM-PAC). Ninety-seven percent of patients reported CRF, and 57% reported severe CRF upon admission. Patients demonstrated on average a 30% and 14% reduction in functional impairment in basic mobility and daily activity respectively during their admission. There was no significant correlation found between CRF on admission and change in functional impairment. This study contributes to existing literature in that it found patients who received inpatient rehabilitation services demonstrate significant improvement in their functional status despite reporting CRF upon admission to a long-term acute care hospital oncology unit.

Prolonged exposure therapy for PTSD among spinal cord injury survivors: Study protocol for a randomized controlled trial

The National Spinal Cord Injury Statistical Center estimates 294,000 people in the US live with a spinal cord injury (SCI), with approximately 17,810 new cases each year. Although the physical outcomes associated with SCI have been widely studied, the psychological consequences of sustaining a SCI remain largely unexplored. Scant research has focused on posttraumatic stress disorder (PTSD) in this population, despite prevalence estimates suggesting that up to 60% of individuals with SCI experience PTSD post-injury, compared to only 7% of the general US population. Fortunately, prolonged exposure therapy (PE) is a well-researched and highly effective treatment for PTSD. However, no trauma focused exposure-based therapy for PTSD (e.g. PE) has not yet been tested in a SCI population. Thus, we aim to conduct the first test of an evidence-based intervention for PTSD among patients with SCI. Adults with SCI and PTSD (N = 60) will be randomly assigned to either: (1) 12-sessions of PE (2–3 sessions per week) or (2) a treatment as usual (TAU) control group who will receive the standard inpatient rehabilitation care for SCI patients. Primary outcomes will be assessed at 0, 6, 10, and 32 weeks.

Fast-track rehabilitation after total knee arthroplasty reduces length of hospital stay: A prospective, case-control clinical trial.

Objectives The aim of this study was to compare the impact of fast-track rehabilitation (FTR) and conventional rehabilitation (CR) on early recovery pattern after fast-track surgery for knee arthroplasty and conventional total knee arthroplasty (TKA). Patients and methods This prospective, case-control study included a total of 43 adult patients (10 males, 33 females; mean age 69 years; range, 50 to 82 years) who were clinically stable and admitted for rehabilitation after fast-track surgery for knee arthroplasty or conventional TKA January 2016 and August 2016. The patients were divided into two groups as the FTR and CR treatment groups. The FTR program was designed as a patient-focused care, early mobilization, and standardized postoperative milestones. The CR program was designed by standard postoperative rehabilitation care. Primary outcomes were the length of stay (LOS) in the hospital and knee function. Secondary outcomes were pain and activities of daily living. Results At baseline, both groups were similar in terms of demographic data and primary outcomes. At discharge, intra-group analysis showed significant differences in both groups in all functional outcomes, except for pain, while the inter-group LOS was also significantly different (p<0.001). Conclusion Our study results indicate that LOS can be reduced by FTR, yielding the same results in functional recovery and autonomy as CR.

Biodex© training post-stroke for postural stability in the upper trunk: A pilot study.

BackgroundStroke affects upper trunk postural stability and upper limb function in approximately 85% of stroke survivors. Upper trunk postural stability is essential for functioning of the upper limb and is a prerequisite for hand function. The rehabilitation of the upper limb and upper trunk post-stroke remains a challenge because of poor recovery of motor and sensory function.ObjectivesTo determine the effect of Biodex© upper limb weight-bearing training on upper trunk postural stability in patients post-stroke.MethodA longitudinal randomised control pilot trial with single blinding was undertaken to assess postural stability on the Biodex© at baseline and 1-month post-baseline. In addition to standard rehabilitative care, upper limb weight-bearing training on the Biodex© was added for participants in the experimental group. Descriptive data analysis and the Mann–Whitney test for group comparisons were done using STATA (p < 0.05).ResultsFifteen participants took part, seven in the control and eight in the experimental group, with an overall median age of 55 years. At baseline there were statistically significant lower scores in the experimental group on overall (p = 0.02) and anterior/posterior (p = 0.009) stability level 6 (moderately unstable base of support) in the upper trunk postural stability scores. No statistically significant improvements were noted between groups on any of the Biodex© stability levels at 1-month post-baseline testing (p > 0.05).ConclusionUpper limb weight-bearing training with the addition of Biodex© training did not result in improvements in upper trunk postural stability.Clinical implicationsThe findings suggest that exercising on a moderately unstable base of support may improve upper trunk postural stability in patients post-stroke. The addition of Biodex© training to standard rehabilitative care for retraining and exercising upper trunk postural control in a weight-bearing position does not lead to better outcomes than standard care.

Platelet rich plasma injection for acute Achilles tendon rupture: PATH-2 randomised, placebo controlled, superiority trial

ObjectiveTo determine whether an injection of platelet rich plasma improves outcomes after acute Achilles tendon rupture.DesignRandomised, placebo controlled, two arm, parallel group, participant and assessor masked, superiority trial.SettingSecondary care trauma...

Effects of transcutaneous electrical nerve stimulation (TENS) on acute postoperative pain intensity and mobility after hip fracture: A double-blinded, randomized trial.

BackgroundTranscutaneous electrical nerve stimulation (TENS) is a noninvasive modality which may be used to reduce acute postoperative pain. Intense perioperative pain within the first few days after hip fracture surgery is common and is related to negative consequences such as restricted and delayed ambulation.ObjectiveThe objective of the present study was to examine the effect of incorporating TENS treatment on pain intensity, and mobility, with standard rehabilitation care during the acute post-operative phase following Gamma-nail surgical fixation of extracapsular hip fractures.Materials and methodsForty-one patients were randomly assigned to a supplement of 30 mins of active TENS or sham TENS. The standard rehabilitation care included five daily 30 mins physical therapy treatments beginning 24 hrs after surgery. Outcome measures were: pain intensity at rest, at night and during ambulation (assessed with the Numeric Rating Scale; Functional Ambulation Classification instrument; time to complete five sit-to-stand tests; and two-minute walk test). Data were analyzed with Wilcoxon score rank tests. Significance was set at p≤0.05.ResultsSignificantly greater pain reduction during walking was noted in the active TENS group compared to sham TENS group (differences between the fifth and the second days: 2.55±1.37 vs 1.06± 1.11, respectively; p=0.0011). Additionally, advantage of active TENS was demonstrated in greater increase in walking distance on the fifth day and higher level of mobility compared to the sham TENS group. No additional effects of active TENS were noted on pain intensity at rest and at night and on five times sit-to-stand performance.ConclusionAddition of TENS to the standard care of elderly patients in the early days following Gamma nail surgical fixation of extracapsular hip fracture is recommended for pain management while walking and functional gait recovery. The effect of TENS on long-term functional outcomes should be explored in future studies.Trial registrationThe trial was registered at the ISRCTN registry: ID ISRCTN32476360.

Effects of "plate model" as a part of dietary intervention for rehabilitation following myocardial infarction: a randomized controlled trial.

Reducing body weight by nutritional management is an integral element of cardiac rehabilitation and in secondary prevention of cardiovascular diseases. Administration of a "plate model" is one practical aspect to control calorie intake. The study aimed to evaluate the effectiveness of the plate model as a part of dietary modification in losing excess weight in post-myocardial infarction (MI) patients. An interventional, randomized, single-blinded study with parallel subject allocation was conducted among patients with a history of troponin-positive acute coronary syndrome (ACS). A total of 120 patients were recruited to intervention and control groups. The Intervention cluster was provided with 'plate model' and both groups received standard cardiac rehabilitation care. Anthropometric, clinical and metabolic parameters were measured at recruitment and repeated during 4th and 12th week. A sample of 79 patients (the intervention group: 40, the control group: 39) completed the study. At the end of 12 weeks participants in the intervention group exhibited a significant weight loss (-1.27±3.58 vs. -0.26±2.42 kg; P=0.029) and a significant reduction in BMI (-0.48±1.31 vs. -0.10±0.89 kg/m2; P=0.023). Overweight and obese patients (BMI >23 kg/m2) displayed greater weight loss (-2.13±3.46 vs. 0.12±2.62 kg; P=0.013). Many of overweight and obese patients in the test group (35.7%) experienced a weight loss ≥5% compared to the control group (13.04%) which was a nearly significant result (P=0.065). No significant changes observed in other metabolic parameters. Plate model is an effective dietary intervention in view of weight reduction in post-MI patients.

The safety, efficacy and cost-effectiveness of the Maxm Skate, a lower limb rehabilitation device for use following total knee arthroplasty: study protocol for a randomised controlled trial

BackgroundPhysical rehabilitation is required to enhance functional outcomes and overall recovery following total knee arthroplasty (TKA). However, there are no universally accepted clinical guidelines available to consistently structure rehabilitation for TKA patients. A common method is rehabilitation provided in an outpatient setting, on a one-to-one treatment basis. This method is resource-intensive and outcomes must be compared to less costly alternatives such as home-based rehabilitation. The current study will analyse a novel home-based rehabilitation program. The Maxm skate is a portable, lower-limb, postoperative, rehabilitation exercise device for individual use in a hospital or home-based setting. This study was developed to compare the safety, efficacy and cost-effectiveness of the Maxm Skate rehabilitation program to standard rehabilitative care following TKA. The primary outcome is the range of motion (ROM) achieved by patients who received the Maxm Skate program compared to standard care at three months post TKA. Secondary outcomes include patient-reported outcomes, costs and functional evaluations which will be collected at multiple time-points up to 12 months after TKA.MethodsThis is a single-blinded, randomised controlled trial (RCT) in which 116 eligible participants consented for primary TKA will be randomly allocated to receive either the Maxm Skate rehabilitation program or standard rehabilitative care. Fifty-eight participants per group will provide 90% power (α = 0.05) to detect 10° of difference in ROM between groups at three months after TKA, assuming a within-group standard deviation of 16° and allowing for 5% loss to follow-up. Participants randomised to the Maxm Skate group will use the skate device and accompanying iOS App and sensors to complete rehabilitation exercises, as outlined in the Maxm Skate Rehabilitation Guide. Outcomes will be compared to those receiving standard rehabilitative care.A blinded physiotherapist will evaluate functional outcomes preoperatively and at 2, 4, 6, 12, 26 and 52 weeks after TKA. The functional assessment will include measures of knee ROM, pain, isometric knee strength, balance and knee/thigh circumference. Limited measures will also be assessed at day 2 postoperatively by an alternate, unblinded physiotherapist. Clinical outcome measures will be administered preoperatively and at 6, 12 and 52 weeks postoperatively. An economic evaluation will be conducted and participants will be screened for adverse event occurrences from the time of consent to 12 months postoperatively.DiscussionThis RCT will be the first to investigate the safety, efficacy and cost-effectiveness of the home-based Maxm Skate Rehabilitation program, in comparison to standard rehabilitative care following primary TKA.Trial registrationAustralian New Zealand Clinical Trials Registry, ACTRN12616001081404p. Registered on 11 August 2016.