Unaffected Arm Research Articles

Assessment of Arm Volume Using a Tape Measure Versus a 3D Optical Scanner in Survivors with Breast Cancer-Related Lymphedema.

Background: Lymphedema (LE) is a significant clinical problem for breast cancer survivors. While the water displacement test and circumferential assessment using a tape measure (TM) are common methods to assess differences in arm volumes, faster and more reliable methods are needed. Study purposes, in breast cancer survivors (n = 294), were to compare the average total arm volumes and interlimb volume ratios for women with and without a history of LE, using a TM and three-dimensional (3D), whole-body surface scanner (3D scan); compare the level of agreement between arm volumes and interlimb volume ratios obtained using the two devices; and evaluate the percent agreement between the two measures in classifying cases of LE using three accepted thresholds. Methods and Results: Measurements were done using a spring-loaded TM and Fit3D ProScanner. Paired t-tests and Bland-Altman analyses were used to achieve the study aims. For circumference and volume comparisons, compared with the 3D scan, values obtained using the TM were consistently smaller. In terms of level of agreement, the Bland-Altman analyses demonstrated large biases and wide limits of agreement for the calculated arm volumes and volume ratios. In terms of the classification of caseness, using the 200-mL interlimb volume difference criterion resulted in 81.6% overall agreement; using the >10% volume difference between the affected and unaffected arms resulted in 78.5% overall agreement; and using the volume ratio ≥1.04 criterion resulted in 62.5% overall agreement. For all three accepted threshold criteria, the percentage of cases was significantly different between the TM and 3D scan techniques. Conclusions: The 3D technology evaluated in this study has the potential to be used for self-initiated surveillance for LE. With improvements in landmark identification and software modifications, it is possible that accurate and reliable total arm volumes can be calculated and used for early detection.

Assessment of Arm Lean Mass, Fat Mass, and Bone Mineral Density in Breast Cancer Survivors Without Lymphedema.

To compare lean mass, fat mass, and bone mineral density (BMD) in the affected arm (the arm on the side where breast cancer was present) and unaffected arm of breast cancer survivors without lymphedema. 38 breast cancer survivors who had completed primary treatment were included in this analysis at a university in Florida. Arm lean mass, fat mass, and BMD were obtained using dual-energy x-ray absorptiometry. Paired t tests were used to compare tissue composition and BMD between the affected and unaffected arm. Independent t tests were used to compare interlimb differences between those participants whose affected arm was on the dominant and those whose affected arm was on the nondominant side. Significance was accepted at p < 0.05. The affected arm had lower fat mass and BMD as compared to the unaffected arm. Differences in lean mass were not statistically significant (p = 0.06). In breast cancer survivors whose nondominant arm was affected, lean mass, fat mass, and BMD were significantly lower in the affected arm. The results show that the affected arm of breast cancer survivors is susceptible to negative tissue and BMD changes. This highlights the importance of educating individuals with breast cancer about these changes and supports the benefits of upper body resistance training.

Does rTMS Targeting Contralesional S1 Enhance Upper Limb Somatosensory Function in Chronic Stroke? A Proof-of-Principle Study

Background Somatosensory deficits are prevalent after stroke, but effective interventions are limited. Brain stimulation of the contralesional primary somatosensory cortex (S1) is a promising adjunct to peripherally administered rehabilitation therapies. Objective To assess short-term effects of repetitive transcranial magnetic stimulation (rTMS) targeting contralesional (S1) of the upper extremity. Methods Using a single-session randomized crossover design, stroke survivors with upper extremity somatosensory loss participated in 3 rTMS treatments targeting contralesional S1: Sham, 5 Hz, and 1 Hz. rTMS was delivered concurrently with peripheral of sensory electrical stimulation and vibration of the affected hand. Outcomes included 2-point discrimination (2PD), proprioception, vibration perception threshold, monofilament threshold (size), and somatosensory evoked potential (SEP). Measures were collected before, immediately after treatment, and 1 hour after treatment. Mixed models were fit to analyze the effects of the 3 interventions. Results Subjects were 59.8 ± 8.1 years old and 45 ± 39 months poststroke. There was improvement in 2PD after 5-Hz rTMS for the stroke-affected (F(2, 76.163) = 3.5, P = .035) and unaffected arm (F(2, 192.786) = 10.6, P < .0001). Peak-to-peak SEP amplitudes were greater after 5-Hz rTMS for N33-P45 (F(2, 133.027) = 3.518, P = .032) and N45-P60 (F(2, 67.353) = 3.212, P = .047). Latencies shortened after 5-Hz rTMS for N20 (F(2, 69.64) = 3.37, P = .04), N60 (F(2, 47.343) = 4.375, P = .018), and P100 (F(2, 37.608) = 3.537, P = .039) peaks. There were no differences between changes immediately after the intervention and an hour later. Conclusions Short-term application of facilitatory high-frequency rTMS (5Hz) to contralesional S1 combined with peripheral somatosensory stimulation may promote somatosensory function. This intervention may serve as a useful adjunct in somatosensory rehabilitation after stroke.

A rare presentation of Takayasu\u2019s arteritis- unilateral finger clubbing \u2013 case report

BackgroundTakayasu’s arteritis (TA) is a granulomatous, large vessel vasculitis with a preponderance for young women. The inflammation results in disruption of the arterial endothelium causing stenosis, endoluminal thrombosis and aneurismal dilatation. Early disease presentation is with nonspecific general symptoms, and in such instances, the diagnosis can be missed. Unilateral clubbing is a manifestation of myriad of diseases, but is not a common sign of TA. In medical literature, only three such cases have been reported.Case presentationWe present a 24-year-old female who presented with multiple constitutional symptoms such as arthralgia, malaise, poor appetite and two episodes of syncope over 3 months’ duration. On examination, unilateral finger clubbing was observed in the right hand, with very low volume radial, ulnar and brachial artery pulses on the ipsilateral side. Her blood pressure measured on the unaffected arm, was normal. Inflammatory markers were elevated and magnetic resonance angiogram (MRA) confirmed TA.ConclusionAlthough rare, unilateral clubbing may be a manifestation of TA. Therefore, detection of unilateral clubbing should raise a strong clinical suspicion of TA and prompt early diagnosis and initiation of treatment.

Effects of Trunk Exercise on Unstable Surfaces in Persons with Stroke: A Randomized Controlled Trial.

Background: Improving balance-related ability is an important goal in stroke rehabilitation. Evidence is needed to demonstrate how this goal could be better achieved. Aim: Determine if trunk exercises on unstable surfaces would improve trunk control and balance for persons in the subacute stage of stroke. Design: An assessor-blind randomized controlled trial. Setting: Inpatients in the department of rehabilitation in a general hospital. Population: Patients who suffered a first-time stroke with onset from one to six months. Methods: Inpatients with stroke were assigned to upper limb exercises (control group, n = 17) or trunk exercises on unstable surfaces (experimental group, n = 18) to receive training twice a week for six weeks, in addition to their daily conventional stroke rehabilitation. Sensorimotor function tests, including hand grip, plantar sensitivity, stroke rehabilitation assessment of movement and Fugl-Meyer lower extremity motor scale, and clinical outcome assessments, including Trunk Impairment Scale and 6 m walk test, were conducted before and after six weeks of training. The center of the pressure area while maintaining static posture and peak displacement while leaning forward, as well as the average speed of raising the unaffected arm, were measured in sitting without foot support, sitting with foot support and standing to reflect trunk control, sitting balance and standing balance, respectively. Results: The between-group differences in the sensorimotor functions were nonsignificant before and after training. Compared with the control group, the experimental group had significantly greater forward leaning and faster arm raising in sitting without foot support, higher Trunk Impairment Scale total score, and shorter 6 m walking time after training, but not before training. Conclusion: Trunk exercises on unstable surfaces could further improve trunk control, the ability to raise the unaffected arm rapidly in sitting, and walking for persons in the subacute stage of stroke. This intervention may be considered to be included in stroke rehabilitation.

Effect of Task-Oriented Bilateral Movements on Arm Global Synkinesis and Activities of Daily Living in Patients with Stroke

Background: Stroke patients exhibit arm global synkinesis (GS), involuntary movement due to muscle weakness and irregular muscle tension. But currently there are few studies examined the effects of GS on activates of daily living in stroke patients. Objectives: To investigate the effects the effects of task-oriented bilateral movements, which promote brain plasticity and are based on neurological theory, using the unaffected arm and the affected arm. Design: Quasi-randomized trial. Methods: Twenty stroke patients were randomly assigned to experimental group I (n=10) and experimental group II (n=10). Before the intervention, arm GS was measured using surface electromyography, and the Motor Activity Log evaluated the quantitative and qualitative uses of the affected arm in daily life. The same items were measured four weeks later. Results: The changes in the GS of the arm of experimental group I showed statistically significant differences only in bending motions (P<.05). Both groups showed statistically significant differences in the amount of use (AOU) and the quality of movement (QOM) scores (P<.01). Comparing the groups, statistically significant differences in GS appeared during bending motions (P<.05), and in the AOU (P<.01) and the QOM scores (P<.05). Conclusion: The intervention in GS reduced the abnormal muscle tension of the affected side by increasing the use of the ipsilateral motor pathway, indicating its effectiveness in improving upper limb functions with smooth contraction and relaxation of the muscles.

Interchangeability of Two Electrode Placement Protocols Used by Bioimpedance Spectroscopy Devices in the Detection of Breast Cancer-Related Lymphedema.

Background: Bioimpedance spectroscopy (BIS) devices are routinely used in the assessment of breast cancer-related lymphedema (BCRL). The equipotential electrode placement is a commonly used protocol for the assessment of BCRL. However, the sternal notch electrode placement protocol is also in use. Whether these two protocols are interchangeable is not known. Methods and Results: Ethical approval was received from the institutional ethics committee at Tata Memorial Hospital, India. BIS measurements (whole-body right side and affected and unaffected arms) of 100 women with or at risk of BCRL were measured using equipotential and sternal notch protocols. Resistance at zero frequency (R0) was determined, and agreement of the absolute R0 values and the R0 ratio (unaffected/affected) between protocols was evaluated (Bland-Altman analysis and Passing-Bablok regression analysis). Mean absolute differences between protocols were very small for whole-body right side, affected arm, unaffected arm, and the interarm ratio at 0.23 ohms (95% confidence interval [CI]: -3.8 to 4.3), -5.7 ohms (95% CI: -7.5 to -3.9), -9.09 ohms (95% CI: -11.4 to -6.8), and -0.008 ohms (95% CI: -0.02 to 0.001), respectively. Limits of agreement (two standard deviation) between protocols were narrow for whole-body right side, affected arm, unaffected arm, and interarm ratio without any systematic or proportional differences for whole-body right side and the interarm ratio (5.8% to -5.6%, 3.7% to -7.4%, 3.5% to -8.2%, and 5.8% to -5.6%, respectively). Conclusion: The equipotential and sternal notch protocols could be used interchangeably in BCRL assessment. The Clinical Trial Registration number: CTRI/2017/12/010762.

EEG Changes in Time and Time-Frequency Domain During Movement Preparation and Execution in Stroke Patients.

This study investigated electroencephalogram (EEG) changes during movement preparation and execution in stroke patients. EEG-based event-related potential (ERP) technology was used to measure brain activity changes. Seventeen stroke patients participated in this study and completed ERP tests that were designed to measure EEG changes during unilateral upper limb movements in preparation and execution stages, with Instruction Response Movement (IRM) and Cued Instruction Response Movement (CIRM) paradigms. EEG data were analyzed using motor potential (MP) in the time domain and the mu-rhythm and beta frequency band response mean value (R-means) in the time–frequency domain. In IRM, the MP amplitude at Cz was higher during hemiplegic arm movement than during unaffected arm movement. MP latency was shorter at Cz and the contralesional motor cortex during hemiplegic arm movement in CIRM compared to IRM. No significant differences were found in R-means among locations, between movement sides in both ERP tests. This study presents the brain activity changes in the time and time–frequency domains in stroke patients during movement preparation and execution and supports the contralesional compensation and adjacent-region compensation mechanism of post-stroke brain reconstruction. These findings may contribute to future rehabilitation research about neuroplasticity and technology development such as the brain–computer interface.

Shoulder Rotation Function Following the Sup-ER Protocol in Children with Brachial Plexus Injuries.

Background: Our group previously developed an upper extremity repositioning (Sup-ER) protocol for brachial plexus birth injuries (BPBIs) that may improve supination and external rotation (ER) at 2 years of age. Questions were raised about the potential for the protocol to cause internal rotation (IR) deficits. The goal of this study was to explore the longer-term outcomes of the Sup-ER protocol and investigate IR/ER function. Methods: This prospective cross-sectional cohort study examined 16 children older than 4 years of age with significant enough BPBI to be treated with the Sup-ER protocol. Total shoulder and elbow function were assessed, including passive and active ranges of motion and strength of IR and ER. Results: Range of motion (ROM) for most active movements was decreased in the affected compared to unaffected arm. Notably, IR passive ROM was similar in the affected (78.7°) and unaffected arm (82.8°). External rotation strength of the affected arm was weaker (42.8 N) compared to the unaffected arm (57.9 N). IR strength had a greater deficit in the affected (43.2 N) arm compared to the unaffected arm (72.2 N), but both ER and IR showed less deficit than described in the literature. Conclusions: Despite differences in ranges of motion between the affected and unaffected arms, ROMs for the affected arm were comparable to the functional limits as reported in the literature. The Sup-ER protocol shows potential to optimize long-term shoulder rotation function in children with BPBI without compromising IR.

Water Reductive Effect of Lymphaticovenular Anastomosis on Upper-Limb Lymphedema: Bioelectrical Impedance Analysis and Comparison with Lower-Limb Lymphedema.

We previously examined the water reductive effect of lymphaticovenular anastomosis (LVA) using bioelectrical impedance analysis (BIA) measurement on lower-limb lymphedema and revealed mean water volume reduction and edema reduction rate by leg LVA to be 0.86 L and 45.1%, respectively. This study aimed to clarify the water reductive effect of LVA on arm lymphedema and compare its results with those for leg lymphedema. The efficacy of LVA for unilateral arm lymphedema was evaluated using BIA in a retrospective cohort. Limb circumference and arm body water volume (ABW) of the affected and unaffected arms were measured before and after LVA. Mean water volume reduction (ΔABW) and edema reduction rate by arm LVA were compared with values for leg LVA cited from our previous report as a historical control. Nineteen consecutive patients were enrolled. The mean ΔABW and edema reduction rate by BIA were 0.267 L and 46.0%, respectively. The decreasing rate of ABW by BIA was significantly larger than those of the upper extremity lymphedema index and sum of 5 circumferences measurement methods. ΔABW could be predicted by a regression line based on the preoperative water volume difference between affected and unaffected limbs. The mean edema reduction rates for arm and leg LVA were comparable. The water reductive effect of LVA on upper-limb lymphedema was demonstrated by BIA assessment. BIA can reflect the effect of LVA more sensitively than conventional objective measurements and may facilitate the interpretation of LVA results. Although water volume reduction by arm LVA was less than that by leg LVA, the edema reduction rates were comparable.

Changes in Nerve Conduction Studies After Distal Radius Fracture Fixation Using a Volar Approach and Locked Plate

PurposeTo determine whether there are changes in nerve conduction studies (NCS) of the median nerve after distal radius fracture (DRF) and to determine how operative fixation through a volar approach with a locking plate contributes to nerve conduction changes. We hypothesized that a considerable percentage of patients would have electrodiagnostic evidence of median neuropathy at the wrist after fracture, but fixation with a volar locked plate would not worsen the electrodiagnostic findings.MethodsThis was a prospective cohort study of 14 neurologically asymptomatic patients who underwent surgical treatment of an isolated DRF using a volar plate. All patients underwent surgery within 2 weeks of injury. On the day of surgery and at the 6-week follow-up, patients were clinically examined, Quick–Disabilities of the Arm, Shoulder, and Hand questionnaire was completed, and patients underwent NCS using a handheld device with the unaffected limb, which was used as a comparison. Preoperative and postoperative nerve function were compared with the unaffected limb as a baseline.ResultsPatients without symptoms after DRF had a 28% incidence of prolonged latencies compared with reference values for the device used. Distal sensory latencies of the median nerve were 3.64 ± 0.32 ms in the unaffected arm, 3.76 ± 0.70 ms before surgery, and 3.81 ± 0.52 ms after surgery. Distal motor latencies of the median nerve were 3.91 ± 0.59, 3.60 ± 0.68, and 3.88 ± 0.36 ms in respective arms and time points. Quick–Disabilities of the Arm, Shoulder, and Hand scores improved from 77 before surgery to 46 at 6 weeks.ConclusionsAsymptomatic patients may satisfy nerve conduction criteria for median neuropathy at the wrist after DRF; however, open reduction and treatment with a volar locked plate has no significant effect on NCS findings.Type of study/level of evidencePrognostic II.

Is the blood pressure different between the paralyzed and unaffected arms or legs?

To investigate whether the blood pressure (BP) levels are similar between the paralyzed and unaffected arms or legs. This study enrolled 236 post-stroke patients with hemiplegic paralysis. Simultaneous four-limb BP was measured using four automatic BP devices for three times, and the average was used as final value. The inter-arm difference (IAD) and inter-ankle difference (IAND) were the BP difference between the arms or ankles, respectively. The difference between maximal BP reading and minimal BP reading was calculated as △BP to reflect the variation of three BP readings. The paralyzed arm had similar mean SBP (134.8 ± 18.7 vs. 135.1 ± 19.0 mmHg, NS) and DBP (79.5 ± 11.3 vs 78.1 ± 10.4 mmHg, NS) levels as compared with the unaffected arm. Similarly, the mean ankle SBP (143.6 ± 19.1 vs. 143.7 ± 18.6 mmHg, NS) and DBP (77.9 ± 17.7 vs. 75.8 ± 11.1 mmHg, NS) in the paralyzed legs were also similar to those in the unaffected legs. The detection rate of systolic IAD ≥10 mmHg was 5.9% and that for systolic IAND ≥15 mmHg was 20.3%. Meanwhile, △SBP levels were similar between two arms or ankles. In the post-stroke patients with hemiplegic paralysis, the SBP and DBP levels of the paralyzed and unaffected arms or ankles were similar.

Effects of weight reduction on the breast cancer-related lymphedema: A systematic review and meta-analysis

BackgroundObesity has long been considered a risk factor for breast cancer–related lymphedema (BCRL), but the benefits of weight reduction in managing BCRL have not been clearly established. ObjectiveTo evaluate the beneficial effects of weight loss interventions (WLIs) on the reduction and prevention of BCRL. MethodsWe conducted a systematic review and meta-analysis by searching the PubMed, Scopus, and Embase databases from their earliest record to October 1st, 2019. We included randomized and non-randomized controlled trials involving adult patients with a history of breast cancer, that compared WLI groups with no-WLI groups, and provided quantitative measurements of lymphedema. ResultsInitial literature search yielded 461 nonduplicate records. After exclusion based on title, abstract, and full-text review, four randomized controlled trials involving 460 participants were included for quantitative analysis. Our meta-analysis revealed a significant between-group mean difference (MD) regarding the volume of affected arm (MD = 244.7 mL, 95% confidence interval [CI]: 145.3–344.0) and volume of unaffected arm (MD = 234.5 mL, 95% CI: 146.9–322.1). However, a nonsignificant between-group MD of −0.07% (95% CI: 1.22–1.08) was observed regarding the interlimb volume difference at the end of the WLIs. ConclusionsIn patients with BCRL, WLIs are associated with decreased volume of the affected and unaffected arms but not with decreased severity of BCRL measured by interlimb difference in arm volume.

Interpretation and content validity of the items of the numeric rating version short-WORC to evaluate outcomes in management of rotator cuff pathology: a cognitive interview approach

BackgroundThe shortened version of the Western Ontario Rotator Cuff Index (Short-WORC) is a patient reported outcome measure that evaluates quality of life (QoL) of patients with rotator cuff pathology. However, formal content validation of the full or Short-WORC has not been reported. This study aims to understand how 1) people interpret and calibrate responses to items on the Short-WORC and 2) compensatory strategies that might enhance function and thereby affect responses.MethodsThis study uses cognitive interviewing, a qualitative methodology that focuses on the interpretation of questionnaire items. Patients with rotator cuff disorders (n = 10), clinicians (n = 6) and measurement researchers (n = 10) were interviewed using a talk aloud structured interview that evaluated each of the 7 items of the Short-WORC. All interviews were recorded and transcribed verbatim by one researcher (R.F). Analysis was done through an open coding scheme using a previously established framework.ResultsOverall, the items on the Short-WORC were well received by participants. Through the interviews, the 6 themes of: Comprehension, Inadequate response definition, Reference Point, Relevance, Perspective Modifiers and Calibration Across Items emerged. The items of working above the shoulder (90%), compensating with the unaffected arm (88%) and lifting heavy objects (92%) were the most relevant to participants. Participants calibrated their scores on the items of sleeping and styling (19%) the most. Perspective modifiers of gender, influenced the calibrations of items of styling your hair (30%) and dressing or undressing (19%). Compensatory strategies of task-re allocation and using assistive devices/resources were frequently mentioned by participants. Overall, participants had minor comprehension issues, but found the 7- items of the Short-WORC to be relevant to QoL.ConclusionsTherefore, the findings demonstrate that the Short-WORC is not cognitively complex, but varies with patient perspectives. Overall, the Short-WORC provides evidence of demonstrating strong content validity when used for rotator cuff disorder patients.

Restoration of peak strength and endurance following distal biceps reconstruction with allograft for chronic ruptures

Distal biceps reconstruction for chronic rupture often requires a graft to recover length and allow for distal tendon reattachment to bone. Our purpose was to assess peak strength and endurance recovery following biceps reconstruction with tendon grafts. We hypothesized that allograft reconstruction would result in decreased flexion and supination peak strength and endurance. Consecutive distal biceps reconstructions with allograft, performed for chronic ruptures between January2008 and March2018 at a single institution, were reviewed. Isokinetic dynamometry for peak strength and endurance testing was performed on the operative and contralateral arms in flexion and supination. Functional outcomes and overall satisfaction with the operation were determined. Eleven patients were available for a complete evaluation, including dynamometry, at a mean of 46 months postoperatively. Reconstructions demonstrated a nonsignificant trend toward decreased peak flexion strength (P = .06), and significantly decreased peak supination strength (P = .01) compared with the unaffected arm. There were no differences in flexion and supination endurance between the affected and unaffected arms. Using standardized outcome scales, patients reported excellent function. Chronic biceps ruptures undergoing reconstruction are highly functional and patients are satisfied. Somewhat surprisingly, supination and flexion endurance were equal to the contralateral, uninvolved arm. However, this procedure does not restore peak supination strength.

Pathologic arterial changes in neurovascularly intact Gartland III supracondylar humerus fractures: a pilot study.

This pilot study was performed to describe changes in arterial flow in completely displaced neurovascularly intact Gartland III pediatric supracondylar humerus fractures using Duplex ultrasonography. This is a prospective study of 11 Gartland type III supracondylar humerus fractures with no cortical continuity but with palpable radial pulse and normal neurologic examination. Duplex ultrasonography was performed on injured and uninjured arms, both preoperatively and postpinning, and interpreted by a board-certified pediatric radiologist. Degree of artery stenosis and peak systolic velocity (PSV) of arterial flow were recorded from the duplex. Ultrasound wrist/brachial indexes (WBI) were calculated using the higher value of the radial/brachial or the ulnar/brachial index. Only three patients had normal Duplexes without stenosis and with flow comparable in the brachial, radial, and ulnar arteries of the affected arm, compared to the unaffected arm, both preoperatively and postpinning. One group of six patients had brachial artery stenosis at the fracture site when compared to the artery proximal to the fracture site, increased PSV at the fracture site compared to proximal to the fracture site, and the WBI was variable when compared to the contralateral side. A third group of two patients also had brachial artery stenosis at the fracture site but had decreased PSV and decreased WBI compared to the contralateral side. Type III supracondylar humerus patients with a normal neurovascular examination may have abnormal Duplex ultrasonography with brachial artery stenosis and elevated peak systolic velocity preoperatively although distal flow remains comparable to the contralateral side. Level of evidence: prognostic - Level II.

Abstract OT1-06-01: Lymfactin, an investigational adenoviral gene therapy expressing VEGF-C, is currently studied in a double-blind, randomized, placebo-controlled, multicenter, phase 2 clinical study in patients suffering from breast cancer associated secondary lymphedema (BCAL)

Abstract Background: Over 15,000 new breast cancer associated secondary lymphedema (BCAL) cases are diagnosed annually in the US. For advanced stage secondary lymphedema, the only current treatment options include conservative therapy and surgical interventions. There is no curative treatment available. Lymfactin is a novel adenovirus type 5-based gene therapy expressing human growth factor VEGF-C, which is highly specific for lymphangiogenesis. Lymfactin is administered directly in the tissue with the compromised lymph flow. By promoting the growth of lymphatic vessels, the aim is to restore a functional lymphatic network and flow. In a previous first in human Phase 1 clinical study in 15 patients, a single dose of Lymfactin was administered as an adjunct to lymph node transplantation surgery in BCAL patients. Lymfactin was safe and well tolerated, and no dose limiting toxicities were observed. Data at 12 months showed that the volume difference of the affected arm compared to the normal arm decreased &amp;gt;50% in at least half of the patient population. Improvements in the function of the lymphatic system were also observed by quantitative lymphoscintigraphy and quality of life. We are now investigating the efficacy of Lymfactin in a randomized clinical setting. Trial design: We are currently conducting a double-blind, randomized, placebo-controlled, Phase 2 clinical study with Lymfactin in BCAL patients. This multi-center study is enrolling patients in Finland and in Sweden scheduled for lymph node transplantation surgery. In this study a single dose of Lymfactin or placebo (saline) is administered ex vivo in the lymph node transplant during the surgery. A total of 40 patients will be randomized 1:1 to this study. Main eligibility criteria: 1. Female or male patients with secondary lymphedema associated with the treatment of breast cancer and a. Has undergone sentinel lymph node biopsies and/or lymph node resection in the axilla on the affected side of their breast cancer with initial N1-N2a staging and lymph node metastasis in ≤ 9 axillary lymph nodes. b. Requires garment use as a compression treatment for the lymphedema in the affected arm. c. Has the volume of the affected arm at least 10% greater than the unaffected arm following 7 days without a compression garment. d. Has the presence of pitting edema in the affected arm without compression garment. e. Has had lymphedema for less than 5 years. 2. No evidence of recurrent or active breast cancer for at least 2 years after the breast cancer surgery and/or the end of chemotherapy and/or radiotherapy (excluding endocrine treatment). Specific Aims: Evaluation of the effects of the Lymfactin treatment on the signs and symptoms of lymphedema by comparing the effects of the active study treatment Lymfactin to corresponding placebo up to 24 months post-treatment by measuring the change in the volume of the affected arm, quantitative lymphoscintigraphy, and patient lympedema specific quality of life assessment. Statistical methods: All efficacy analyses will be performed on the intent-to-treat and per protocol analysis sets. The efficacy data parameters will be summarized using descriptive statistics by treatment group and time point, as appropriate. Due to the nature of the study, there are no set formal statistical hypotheses for the efficacy endpoints, but suitable inferential statistics can be used when feasible. Present accrual and target accrual: A total of 40 patients are planned to be included in the clinical study. By the end of June 2019, 15 patients have been enrolled. Contact: Outi Lahdenperä, MD CMO Herantis Pharma Plc E-mail: outi.lahdenpera@herantis.com Tel: +358 40 511 3194 Citation Format: Pauliina Hartiala, Outi Lahdenperä, Antti Vuolanto, Anne Saarikko. Lymfactin, an investigational adenoviral gene therapy expressing VEGF-C, is currently studied in a double-blind, randomized, placebo-controlled, multicenter, phase 2 clinical study in patients suffering from breast cancer associated secondary lymphedema (BCAL) [abstract]. In: Proceedings of the 2019 San Antonio Breast Cancer Symposium; 2019 Dec 10-14; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2020;80(4 Suppl):Abstract nr OT1-06-01.

Actigraphic measurement of the upper limbs movements in acute stroke patients

BackgroundStroke units provide patients with a multiparametric monitoring of vital functions, while no instruments are actually available for a continuous monitoring of patients motor performance. Our aim was to develop an actigraphic index able both to identify the paretic limb and continuously monitor the motor performance of stroke patients in the stroke unit environment.MethodsTwenty consecutive acute stroke patients (mean age 69.2 years SD 10.1, 8 males and 12 females) and 17 bed-restrained patients (mean age 70.5 years SD 7.3, 7 males and 10 females) hospitalized for orthopedic diseases of the lower limbs, but not experiencing neurological symptoms, were enrolled. This last group represented our control group. The motor activity of arms was recorded for 24 h using two programmable actigraphic systems showing off as wrist-worn watches. The firmware segmented the acquisition in epochs of 1 minute and for each epoch calculates two motor activity indices: MAe1 (Epoch-related Motor Activity index) and MAe2 (Epoch-related Motor Activity index 2). MAe1 is defined as the standard deviation of the acceleration module and MAe2 as the module of the standard deviation of acceleration components. To describe the 24 h motor performance of each limb, we calculated the mean value of MAe1 and MAe2 (respectively MA1_24h and MA2_24h). Then we obtained two Asymmetry Rate Indices: AR1_24h and AR2_24h to show the motor activity prevalence. AR1_24h refers to the asymmetry index between the values of MAe1 of both arms and AR2_24h to MAe2 values.The stroke patients were clinically evaluated by NIHSS at the beginning (NIHSST0) and at the end (NIHSST1) of the 24 h actigraphic recordings.ResultsBoth MA1_24h and MA2_24h indices were smaller in the paretic than in the unaffected arm (respectively p = 0.004 and p = 0.004). AR2_24h showed a better capability (95% of paretic arms correctly identified, Phi Coefficient: 0.903) to discriminate the laterality of the clinical deficit than AR1_24h (85% of paretic arms correctly identified, Phi Coefficient: 0,698). We also found that AR1_24h did not differ between the two groups of patients while AR2_24h was greater in stroke patients than in controls and positively correlated with NIHSS total scores (r: 0.714, p < 0.001 for NIHSS, IC95%: 0.42–0.90) and with the sub-score relative to the paretic upper limb (r: 0.812, p < 0.001, IC95%: 0.62–0.96).ConclusionsOur data show that actigraphic monitoring of upper limbs can detect the laterality of the motor deficit and measure the clinical severity. These findings suggest that the above described actigraphic system could implement the existing multiparametric monitoring in stroke units.

The evolution of hand function during remodelling in nonreduced angulated paediatric forearm fractures: a prospective cohort study

Forearm fractures are very common orthopaedic injuries in children. Most of these fractures are forgiving due to the unique and excellent remodelling capacity of the juvenile skeleton. However, significant evidence stating the limits of acceptable angulations and taking functional outcome into consideration is scarce. The aim of this study is, therefore, to get a first impression of the remodelling capacity in nonreduced paediatric forearm fractures based on radiological and functional outcome. Children aged 0–14 years with a traumatic angular deformation of the radius or both the radius and ulna, treated conservatively without reduction, were included in this prospective cohort study. Radiographs were taken and functional outcome was assessed at five fixed follow-up appointments throughout a period of one year. Outcome measurements comprised radiographic angular alignment, grip strength and wrist mobility. A total of 26 children (aged 3–13 years) with a traumatic angulation of the forearm were included. Mean dorsal angulation at the time of presentation amounted to 12° (5–18) and diminished after one year to a mean angulation of 4° (0–13). Grip strength, pronation and supination were significantly diminished compared to the unaffected hand up to 6 months after injury. After one year, no significant differences in function between the affected and the unaffected arm were found. Nonreduced angulated paediatric forearm fractures have the potential to remodel in time and have good radiographic and functional outcome one year after trauma, where pronation and grip strength take the longest to recover.

Ultrasound imaging of upper extremity spastic muscle post-stroke and the correlation with function: A pilot study.

With increased practice of real-time ultrasound imaging in the physical therapy profession, it is essential to evaluate the utility of its use post stroke. Evaluate relationship of spastic brachialis muscle architectural parameters with clinical measures of upper extremity function and spasticity. Eleven post stroke individuals with spasticity of the upper limb had their brachialis muscle pennation angle and fascicle length measured in the affected and unaffected upper arm, at rest. Involved side upper extremity Fugl-Meyer, Modified Ashworth Scale, and grip strength were collected and compared to muscle architectural parameters of affected and unaffected brachialis muscles. Affected side brachialis pennation angle was significantly greater than the unaffected side, and affected fascile length was significantly shorter than the unaffected side. Function levels were found to be significantly higher in those with greater fascile lengths and lower pennation angles. Higher Fugl-Meyer scores of the affected upper extremity were inversely correlated with lower Modified Ashworth Scale scores. An objective method of quantifying spasticity can assist in determining if functional gains made post stroke are due to compensations in movement, or due to physiological changes. Ultrasound imaging may be used as an alternative to the Modified Ashworth score to quantify muscular parameters in spastic muscles post stroke.