A semi-structured interview to capture manual wheelchair use for mobility activities among individuals with spinal cord injury in real-life situations: development and content validity of the Wheelchair Mobility Activity Log (WC-MAL).

STUDY DESIGN: Mixed-method approach. OBJECTIVES: To develop and assess the content validity of a semi-structured interview that captures the lived experience of using a manual wheelchair among individuals with SCI in the real world, the Wheelchair Mobility Activity Log (WC-MAL). SETTING: SCIR-Group (UDESC)/Brazil. METHODS: Developing the WC-MAL comprised five steps: (1) defining the construct-based on the International Classification of Functioning, Disability and Health (ICF); (2) identifying relevant activities from other assessment instruments and interviews with the end-users (14 Individuals with SCI and 13 rehabilitation professionals); (3) Selecting the items - activities were linked to ICF codes and grouped into sets; (4) developing the scoring scales based on interviews with the end-users; and, (5) evaluating content validity in accordance with the COnsensus-based Standards for the selection of health Measurement INstruments (COSMIN). The content validity ratio (CVR) for each item and scale and the overall instrument content validity index (CVI) were calculated. RESULTS: From an initial draft of 295 activities identified, a set of 222 activities was linked to the ICF domain of "Mobility (d4)" and further refined to generate the 23 items in the WC-MAL. Three scales were developed to assess Frequency (how often), Performance (how well), and Assistance (assistance needed) levels. The items and scales showed a CVR superior to the critical value established (≥0.64). The general CVI value was 0.96. CONCLUSION: The WC-MAL is a promising clinical instrument with adequate content validity to assess the spontaneous use of the manual wheelchair in the real world among individuals with SCI.

Telephone-Based Rehabilitation Intervention to Optimize Activity Participation After Breast Cancer: A Randomized Clinical Trial.

Importance: Following treatment, breast cancer survivors face challenges participating in valued activities. Objective: To determine whether a telephone-based coaching rehabilitation intervention enhances activity participation in the year following breast cancer treatment. Design, Setting, and Participants: In this multisite, single-blind randomized clinical trial (Optimizing Functional Recovery of Breast Cancer Survivors), recruitment occurred between August 28, 2019, and April 30, 2022. Data collection was completed by April 1, 2023. Participants were recruited from 2 cancer centers (Dartmouth College and the University of Alabama at Birmingham) and via social media advertisements. Women aged 18 years or older who had completed primary treatment for stage I to III breast cancer within 1 year and reported participation restrictions were eligible to participate. Randomization was stratified by site, treatment, and time since treatment. Interventions: The intervention, delivered via telephone over 9 sessions, used behavioral activation and problem-solving principles to promote activity participation. The education-based attention control condition was delivered via telephone at matched intervals. Main Outcomes and Measures: The primary outcome was participation, assessed using 5 measures, including Patient-Reported Outcomes Measurement Information System (PROMIS) social participation-satisfaction measure. One individualized outcome allowed participants to specify activities for which they wanted to foster recovery. Outcomes were collected by telephone by blinded coordinators at baseline and at 8, 20, and 44 weeks. The individualized outcome was assessed at the first and last intervention and control session. Results: Among 1996 patients identified, 303 were eligible and enrolled. Of these, 284 women (94%; mean [SD] age, 56.1 [10.2] years) completed baseline assessments and were randomized, and 81% or more of each group completed the final assessment with no adverse events. Of those who completed the final assessment, 118 of 114 (82%) were in the intervention group, and 113 of 140 (81%) were attention control participants. Between-group differences were not statistically significant for the main measures of PROMIS satisfaction (week 20: Cohen d, 0.1 [95% CI, -0.09 to 0.29] and week 44: Cohen d, -0.08 [95% CI, -0.27 to 0.11]) and ability (week 20: Cohen d, 0.15 [95% CI, -0.06 to 0.37] and week 44: Cohen d, -0.08 [95% CI, -0.27 to 0.11]). On the individualized outcome, intervention participants reported significantly greater improvements in activity satisfaction (Cohen d, 0.76 [95% CI, 0.48-1.02]) and performance (Cohen d, 0.60 [95% CI, 0.32-0.87]). Conclusions and Relevance: In this randomized clinical trial, the intervention catalyzed greater improvements in self-selected activity participation and goal disengagement but did not otherwise accelerate recovery compared with the control condition. Future research should determine what intervention features may lead to the greatest reductions in participation restrictions and other measures that may detect functional recovery. Trial Registration: ClinicalTrials.gov Identifier: NCT03915548.

Repetitive Peripheral Sensory Stimulation as an Add-On Intervention for Upper Limb Rehabilitation in Stroke: A Randomized Trial.

INTRODUCTION: Repetitive peripheral sensory stimulation (RPSS) followed by 4-hour task-specific training (TST) improves upper limb motor function in subjects with stroke who experience moderate to severe motor upper limb impairments. Here, we compared effects of RPSS vs sham followed by a shorter duration of training in subjects with moderate to severe motor impairments in the chronic phase after stroke. METHODS: This single-center, randomized, placebo-controlled, parallel-group clinical trial compared effects of 18 sessions of either 1.5 h of active RPSS or sham followed by a supervised session that included 45 min of TST of the paretic upper limb. In both groups, subjects were instructed to perform functional tasks at home, without supervision. The primary outcome measure was the Wolf Motor Function Test (WMFT) after 6 weeks of treatment. Grasp and pinch strength were secondary outcomes. RESULTS: In intention-to-treat analysis, WMFT improved significantly in both active and sham groups at 3 and 6 weeks of treatment. Grasp strength improved significantly in the active, but not in the sham group, at 3 and 6 weeks. Pinch strength improved significantly in both groups at 3 weeks, and only in the active group at 6 weeks. CONCLUSIONS: The between-group difference in changes in WMFT was not statistically significant. Despite the short duration of supervised treatment, WMFT improved significantly in subjects treated with RPSS or sham. These findings are relevant to settings that impose constraints in duration of direct contact between therapists and patients. In addition, RPSS led to significant gains in hand strength.Trial Registry Name: Peripheral Nerve Stimulation and Motor Training in Stroke Clinical Trials.gov identifier: NCT0265878 https://clinicaltrials.gov/ct2/show/NCT02658578.

Reliability and Validity of the Lower Extremity Motor Activity Log for Measuring Real-World Leg Use in Adults With Multiple Sclerosis.

OBJECTIVES: To determine the test-retest reliability and validity of the Lower Extremity Motor Activity Log (LE-MAL) for assessing LE use in the community in adults with multiple sclerosis (MS). DESIGN: Prospective analysis of measures conducted by trained examiners. SETTING: Participants were evaluated by telephone on several measures of LE use. PARTICIPANTS: Adults with MS (N=43). INTERVENTIONS: Not applicable. MAIN OUTCOME MEASURES: The LE-MAL has 3 subscales (Assistance, Functional Performance, and Confidence). It was administered twice, at least 2 weeks apart. The Multiple Sclerosis Walking Scale (MSWS-12), Patient Determined Disease Steps (PDDS), and Mobility Scale were only administered during the first call. RESULTS: The test-retest reliability of the composite and the 3 subscale LE-MAL scores were high (intraclass correlation, >0.94). The composite and subscale LE-MAL scores were strongly correlated with the MSWS-12, PDDS, and Mobility Scale scores (r=-0.56 to -0.77; P<.001). CONCLUSION: This initial study suggests that the LE-MAL reliably and validly measures LE use in the community in adults with MS.

Study protocol for a multisite randomised controlled trial of a rehabilitation intervention to reduce participation restrictions among female breast cancer survivors.

INTRODUCTION: Many breast cancer survivors report an inability to fully participate in activities of daily living after completing cancer treatment. Reduced activity participation is linked to negative consequences for individuals (eg, depression, reduced quality of life) and society (reduced workforce participation). There is currently a lack of evidence-based interventions that directly foster cancer survivors' optimal participation in life roles and activities. Pilot study data suggest rehabilitation interventions based on behavioural activation (BA) and problem-solving treatment (PST) can facilitate post-treatment role resumption among breast cancer survivors. METHODS AND ANALYSIS: This protocol describes a multisite randomised controlled trial comparing a 4-month long, nine-session BA and PST-informed rehabilitation intervention (BA/PS) against a time-matched, attention control condition. The overall objective is to assess the efficacy of BA/PS for enhancing breast cancer survivors' activity participation and quality of life over time. A total of 300 breast cancer survivors reporting participation restrictions after completing curative treatment for stage 1-3 breast cancer within the past year will be recruited across two sites (Dartmouth-Hitchcock Medical Center and University of Alabama at Birmingham). Assessments are collected on enrolment (T1) and 8 (T2), 20 (T3) and 44 (T4) weeks later. ETHICS AND DISSEMINATION: Study procedures are approved by the Committee for the Protection of Human Subjects at Dartmouth College, acting as the single Institutional Review Board of record for both study sites (STUDY 00031380). Results of the study will be presented at national meetings and submitted for publication in peer-reviewed journals. TRIAL REGISTRATION NUMBER: NCT03915548; Pre-results.

Constraint-Induced Movement Therapy for Improving Motor Function of the Paretic Lower Extremity After Stroke.

A 56-yr-old woman with chronic stroke and gait dysfunction was recruited for this study. A lower-extremity constraint-induced movement therapy protocol was given consisting of 3.5 hrs/d of supervised intervention activities on 10 consecutive weekdays. Motor training was intensive and involved shaping. In addition, a group of behavior management strategies was used to induce further unsupervised practice and transference of motor skills from the laboratory to real-world situations. Changes in functional mobility, walking speed, balance, level of assistance, perceived quality of movement, and level of confidence while performing daily activities were assessed five times in both the baseline and intervention phases. The outcomes observed after the intervention were determined by calculating the difference between the average scores obtained in both phases. Changes in perceived quality of movement, level of confidence, level of assistance, and balance were observed.

Clinical factors associated with the development of nonuse learned after stroke: a prospective study.

Background: Upper extremity impairment is present in most of people with stroke. The use of the affected upper extremity can be impacted not only by physical impairment but also by abehavioral phenomenon called learned nonuse. Objective: The aim of this study was to evaluate which clinical factors in the acute phase are associated with the development of learned nonuse in the upper extremity after stroke. Methods: This cohort study included 38 patients with ischemic stroke. Hospital discharge data were collected for clinical aspects, scales of severity, incapacity and autonomy, as well as for neuromuscular and sensory evaluations. At 90 days after hospital discharge, the score on the Motor Activity Log scale for detecting learned nonuse was obtained, and life quality was evaluated by the EuroQol. The individuals with and without learned nonuse were compared by attest for univariate analysis, and ageneralized linear model was employed to find possible predictors, which were considered significant p <0.05. Results: In the statistical model, age (p= .006), severity at discharge (p= .036), handgrip strength (p= .000), altered sensitivity (p= .011), incapacity at discharge (p= .009) and autonomy at discharge (p= .011) were found to be associated with learned nonuse. In relation to quality of life, mobility, personal care, usual activities, anxiety, depression and perception had lower mean values in the learned nonuse group. Conclusion: Age, severity of stroke, incapacity and neuromuscular and sensory compromises are associated with upper extremity learned nonuse in stroke patients.

Combined Brain and Peripheral Nerve Stimulation in Chronic Stroke Patients With Moderate to Severe Motor Impairment.

OBJECTIVES: To evaluate effects of somatosensory stimulation in the form of repetitive peripheral nerve sensory stimulation (RPSS) in combination with transcranial direct current stimulation (tDCS), tDCS alone, RPSS alone, or sham RPSS + tDCS as add-on interventions to training of wrist extension with functional electrical stimulation (FES), in chronic stroke patients with moderate to severe upper limb impairments in a crossover design. We hypothesized that the combination of RPSS and tDCS would enhance the effects of FES on active range of movement (ROM) of the paretic wrist to a greater extent than RPSS alone, tDCS alone or sham RPSS + tDCS. MATERIALS AND METHODS: The primary outcome was the active ROM of extension of the paretic wrist. Secondary outcomes were ROM of wrist flexion, grasp, and pinch strength of the paretic and nonparetic upper limbs, and ROM of wrist extension of the nonparetic wrist. Outcomes were blindly evaluated before and after each intervention. Analysis of variance with repeated measures with factors "session" and "time" was performed. RESULTS: After screening 2499 subjects, 22 were included. Data from 20 subjects were analyzed. There were significant effects of "time" for grasp force of the paretic limb and for ROM of wrist extension of the nonparetic limb, but no effects of "session" or interaction "session x time." There were no significant effects of "session," "time," or interaction "session x time" regarding other outcomes. CONCLUSIONS: Single sessions of PSS + tDCS, tDCS alone, or RPSS alone did not improve training effects in chronic stroke patients with moderate to severe impairment.

Translational neurorehabilitation research in the third world: what barriers to trial participation can teach us.

BACKGROUND AND PURPOSE: Most stroke rehabilitation studies have been performed in high-income countries. The aim of this study was to identify the main barriers for patient inclusion in a research protocol performed in Brazil. METHODS: We evaluated reasons for exclusion of patients in a pilot, randomized, double-blinded clinical trial of stroke rehabilitation. Descriptive statistical analysis was performed. RESULTS: Only 5.6% of 571 screened patients were included. Recurrent stroke was responsible for exclusion of 45.4% of potentially eligible patients. CONCLUSIONS: Recurrent stroke represented a big barrier to enroll patients in the protocol. External validity of rehabilitation trials will benefit from definition of study criteria according to regional characteristics of patients, including rates of recurrent stroke. CLINICAL TRIAL REGISTRATION URL: http://www.clinicaltrials.gov. Unique identifier: NCT01333579.

Transcranial magnetic stimulation in mild to severe hemiparesis early after stroke: a proof of principle and novel approach to improve motor function.

Low-frequency repetitive transcranial magnetic stimulation (rTMS) of the unaffected hemisphere can enhance function of the paretic hand in patients with mild motor impairment. Effects of low-frequency rTMS to the contralesional motor cortex at an early stage of mild to severe hemiparesis after stroke are unknown. In this pilot, randomized, double-blind clinical trial we compared the effects of low-frequency rTMS or sham rTMS as add-on therapies to outpatient customary rehabilitation, in 30 patients within 5-45 days after ischemic stroke, and mild to severe hand paresis. The primary feasibility outcome was compliance with the interventions. The primary safety outcome was the proportion of intervention-related adverse events. Performance of the paretic hand in the Jebsen-Taylor test and pinch strength were secondary outcomes. Outcomes were assessed at baseline, after ten sessions of treatment administered over 2 weeks and at 1 month after end of treatment. Baseline clinical features were comparable across groups. For the primary feasibility outcome, compliance with treatment was 100% in the active group and 94% in the sham group. There were no serious intervention-related adverse events. There were significant improvements in performance in the Jebsen-Taylor test (mean, 12.3% 1 month after treatment) and pinch force (mean, 0.5 Newtons) in the active group, but not in the sham group. Low-frequency rTMS to the contralesional motor cortex early after stroke is feasible, safe and potentially effective to improve function of the paretic hand, in patients with mild to severe hemiparesis. These promising results will be valuable to design larger randomized clinical trials.