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.

A Process Evaluation of Intervention Delivery for a Cancer Survivorship Rehabilitation Clinical Trial Conducted during the COVID-19 Pandemic.

The purpose of the present study was to conduct a process evaluation of intervention delivery for a randomized controlled trial (RCT) conducted during the COVID-19 pandemic (NCT03915548). The RCT tested the effects of a telephone-delivered behavioral intervention on changes in breast cancer survivors' satisfaction with social roles and activities, as compared to an attention control condition. This process evaluation examined (a) fidelity monitoring scores; (b) participants' perceived benefit ratings for gaining confidence, reducing distress, adjusting habits and routines, setting goals, and increasing exercise; and (c) field notes, email communications, and transcripts of coach supervision and debriefing sessions. The behavioral and attention control conditions were delivered with a high degree of fidelity (global quality rating score for the BA/PS condition was M = 4.6 (SD = 0.6) and M = 4.9 (SD = 0.3) for the attention control condition, where "5" is the highest rating). The behavioral intervention participants perceived greater benefits than the control participants pertaining to goal setting, t(248) = 5.73, p = <0.0001, adjusting habits and routines, t(248) = 2.94, p = 0.0036, and increasing exercise, t(248) = 4.66, p = <0.0001. Moreover, coaches' perceptions regarding the behavioral intervention's therapeutic aspects aligned with the study's a priori conceptual model including the use of a structured process to set small, observable goals and facilitate the independent use of problem-solving skills. However, coaches also noted that aspects of the attention control condition, including the perceived relevance of the educational content and opportunities for social support, may have made it more therapeutically potent than intended. The pandemic may have affected the activity goals behavioral intervention participants could set as well as augmented the relevancy of social support provided in both conditions.

Enhancing Efficiency and Reach Using Facebook to Recruit Breast Cancer Survivors for a Telephone-Based Supportive Care Randomized Trial During the COVID-19 Pandemic.

PURPOSE: Evidence supporting social media-based recruitment of cancer survivors is limited. This paper describes how we used Facebook during the COVID-19 pandemic to augment our recruitment of breast cancer survivors for our two-site telephone-based randomized clinical trial (RCT) at Dartmouth-Hitchcock Medical Center and the University of Alabama at Birmingham. METHODS: Originally a two-site RCT of a telephone-delivered breast cancer survivorship intervention, we extended our clinic-based recruitment to Facebook. Participant characteristics, geographic reach, and baseline outcomes were compared across recruitment sources (ie, two clinics and Facebook) using descriptive statistics and effect sizes. RESULTS: Enrollment rates (20%-29%) were comparable across recruitment sources. The 21-month Facebook marketing campaign accounted for 59% (n = 179/303) of our total sample and had the greatest geographic reach, recruiting women from 24 states. The Facebook campaign reached a total of 51,787 unique individuals and cost $88.44 in US dollars (USD) per enrolled participant. Clinic samples had a greater proportion of women who were widowed (8% v 1%; P = .03) and Facebook had a higher proportion of women with a household income over $40,000 USD (83% v 71%; P = .02). There were no statistically significant differences between Facebook and the two clinics on baseline survey scores. CONCLUSION: Augmenting traditional recruitment with Facebook increased our RCT's geographic and sociodemographic reach and supported meeting recruitment goals in a timely way. In the wake of the COVID-19 pandemic, cancer survivorship researchers should consider using social media as a recruitment strategy while weighing the advantages and potential biases introduced through such strategies.

Self-reported use of the paretic lower extremity of people with stroke: A reliability and validity study of the Lower-Extremity Motor Activity Log (LE-MAL) - Brazil.

BACKGROUND: Most measures to assess the lower extremity (LE) after a neurological injury assess the lower limb motor capacity in the laboratory or clinical settings as the lower-extremity motor subscale of Fugl Meyer Assessment (FMA-LE). The LE Motor Activity Log (LE-MAL) measures the use of paretic LE in real-life conditions, which for many researchers and stakeholders is considered an important goal of rehabilitation. OBJECTIVE: Investigate the reliability, validity, floor, and ceiling effects of the Brazilian version of the LE-MAL. METHODS: Cross-sectional study to examine the reliability and validity of LE-MAL in patients with chronic stroke. The translation and adaptation of LE-MAL was carried out for the Brazilian version. After this stage, to ensure the inter-rater reliability two raters (LCF, DBM) applied the translated version of LE-MAL in the 21 selected participants. Subsequently, the concurrent validity was calculated by the correlation with the FMA-LE. RESULTS: The translation and retro-translation of the LE-MAL was approved to the Brazilian context. A floor effect was not observed, and there was no ceiling effect for the LE-MAL total scores. The Inter-rater reliability ranged between 0.80 and 0.86. The Bland-Altman analysis showed difference of LE-MAL scores ranged from 0.8 to 1.6. The Cronbach's alpha coefficients for LE-MAL and subscales were high ranging between 0.86 and 0.80. There was a significant moderate correlation between the LE-MAL and FMA-LE (Pearson correlation 0.55 (p = .009)). CONCLUSION: The Brazilian version LE-MAL is valid and reliable to assess real-world use of the paretic LE of individuals with chronic stroke.

Constraint-induced movement therapy for lower extremity use in activities of daily living in people with chronic hemiparesis: multiple case study.

Lower extremity constraint-induced movement therapy (LE-CIMT) is an intensive intervention protocol recently reported to improve lower extremity use in individuals with chronic hemiparesis. To test if the LE-CIMT that uses essential CIMT components, including the transfer package and intensive task-oriented training, is a feasible and potentially effective intervention to improve the lower extremity real-world use and functional ability in a group of individuals with chronic hemiparesis. A quasi-experimental pre- and post-test design study with 12 individuals with chronic stroke and impaired ambulation skills engaged in a 10-weekday LE-CIMT. Intervention feasibility was assessed, examining the training adherence, acceptability, and safety. The lower extremity motor activity log (LE-MAL), lower extremity motor function test (LE-MFT), timed up and go (TUG) and spatiotemporal gait parameters were used as clinical outcomes. Clinical data were collected at baseline, 3-day post-CIMT protocol and 30-day follow-up assessment. At baseline, LE-MAL and LE-MFT outcomes were tested over 2-week apart to ensure a stable measurement and determine the smallest real difference (SRD) in the study sample. The LE-CIMT showed excellent adherence, acceptability and safety. Ten out of 12 participants showed improvements over SRD in LE-MAL composite score (1.2 point) and eight participants in LE-MFT adjusted scores (0.8 point) in post-CIMT and 30-day follow-ups. LE-CIMT is a feasible intervention that has the potential to promote improvements in real-world use and functional ability of the paretic lower extremity in individuals with chronic stroke.

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 Lower Extremity Function: Describing the LE-CIMT Protocol.

Constraint-induced movement therapy (CIMT) is comprised of a set of techniques shown to produce significant changes in upper extremity (UE) function following stroke and other disorders. The significant positive results obtained with the UE protocol have led to the development of LE-CIMT, an intervention to improve lower extremity (LE) function. However, some modifications of the UE protocol were needed, including omitting use of a restraint device, development of supervised motor training tasks to emphasize movement of the lower limb, and adaptation of the UE Motor Activity Log for the lower extremity. The LE-CIMT protocol includes: (1) intensive supervised training delivered for 3.5 h/d for 10 consecutive weekdays, (2) use of shaping as a strategy for motor training, (3) application of a transfer package, and (4) strongly encouraging use of the more-affected LE with improved coordination. The transfer package consists of several strategies to facilitate transfer of the improved motor skills developed during supervised treatment to everyday situations. Research to date has yielded positive results. However, the intervention protocol continues to evolve. The purpose of this article is to describe the components of the complete LE-CIMT protocol to promote further development and investigation of this approach.

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.

Repetitive Peripheral Sensory Stimulation and Upper Limb Performance in Stroke: A Systematic Review and Meta-analysis.

BACKGROUND: Enhancement of sensory input in the form of repetitive peripheral sensory stimulation (RPSS) can enhance excitability of the motor cortex and upper limb performance. OBJECTIVE: To perform a systematic review and meta-analysis of effects of RPSS compared with control stimulation on improvement of motor outcomes in the upper limb of subjects with stroke. METHODS: We searched studies published between 1948 and December 2017 and selected 5 studies that provided individual data and applied a specific paradigm of stimulation (trains of 1-ms pulses at 10 Hz, delivered at 1 Hz). Continuous data were analyzed with means and standard deviations of differences in performance before and after active or control interventions. Adverse events were also assessed. RESULTS: There was a statistically significant beneficial effect of RPSS on motor performance (standard mean difference between active and control RPSS, 0.67; 95% CI, 0.09-1.24; I2 = 65%). Only 1 study included subjects in the subacute phase after stroke. Subgroup analysis of studies that only included subjects in the chronic phase showed a significant effect (1.04; 95% CI, 0.66-1.42) with no heterogeneity. Significant results were obtained for outcomes of body structure and function as well as for outcomes of activity limitation according to the International Classification of Function, Disability and Health, when only studies that included subjects in the chronic phase were analyzed. No serious adverse events were reported. CONCLUSIONS: RPSS is a safe intervention with potential to become an adjuvant tool for upper extremity paresis rehabilitation in subjects with stroke in the chronic phase.

Increase in Short-Interval Intracortical Facilitation of the Motor Cortex after Low-Frequency Repetitive Magnetic Stimulation of the Unaffected Hemisphere in the Subacute Phase after Stroke.

Low-frequency repetitive transcranial magnetic stimulation of the unaffected hemisphere (UH-LF-rTMS) in patients with stroke can decrease interhemispheric inhibition from the unaffected to the affected hemisphere and improve hand dexterity and strength of the paretic hand. The objective of this proof-of-principle study was to explore, for the first time, effects of UH-LF-rTMS as add-on therapy to motor rehabilitation on short-term intracortical inhibition (SICI) and intracortical facilitation (ICF) of the motor cortex of the unaffected hemisphere (M1UH) in patients with ischemic stroke. Eighteen patients were randomized to receive, immediately before rehabilitation treatment, either active or sham UH-LF-rTMS, during two weeks. Resting motor threshold (rMT), SICI, and ICF were measured in M1UH before the first session and after the last session of treatment. There was a significant increase in ICF in the active group compared to the sham group after treatment, and there was no significant differences in changes in rMT or SICI. ICF is a measure of intracortical synaptic excitability, with a relative contribution of spinal mechanisms. ICF is typically upregulated by glutamatergic agonists and downregulated by gabaergic antagonists. The observed increase in ICF in the active group, in this hypothesis-generating study, may be related to M1UH reorganization induced by UH-LF-rTMS.