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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05626894
Other study ID # 2022P002943
Secondary ID R44HD084035
Status Not yet recruiting
Phase Phase 2
First received
Last updated
Start date September 1, 2023
Est. completion date September 30, 2025

Study information

Verified date May 2023
Source Spaulding Rehabilitation Hospital
Contact Paolo Bonato, PhD
Phone 617-952-6319
Email pbonato@partners.org
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The proposed study is a two-arm randomized clinical trial designed to assess the effects of the StrokeWear system on clinical outcomes over a period of 6-months in chronic stroke survivors. The Intervention group will use StrokeWear system in combination to a motor and behavioral home intervention whereas the Control group will follow usual care which consists of a home-exercise plan (HEP).


Description:

The proposed study is a two-arm randomized clinical trial designed to assess the effects of the StrokeWear system on clinical outcomes over a period of 6-months in chronic stroke survivors. The Intervention group will use StrokeWear system in combination to a motor and behavioral home intervention whereas the Control group will follow usual care which consists of a home-exercise plan (HEP). Study participants will be asked to take part in 4 evaluation study visits: one screening and enrollment visit, and three evaluation visits (at baseline, at 3 months and at 6 months - at the intervention completion). Subject upper-extremity motor function will be assessed across domains of the International Classification of Functioning, Disability and Health (ICF) model. Groups will be stratified by baseline motor impairment and stroke chronicity. Subjects randomized to the intervention group will take part of weekly coaching sessions during the first month, bi-weekly sessions during the months 2 and 3, and monthly sessions during months 4-6. These sessions will be held in-person or remotely, based on the study participant preference. Subjects randomized to the control group will take part of monthly visits, held in-person or remotely (based on study participant preference), to re-evaluate the home-exercise plan and prescribe an update list of exercises for the following month.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 32
Est. completion date September 30, 2025
Est. primary completion date June 30, 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years to 85 Years
Eligibility Inclusion Criteria: - Male or female, 18-85 years of age at the time of enrollment; - Anterior circulation ischemic stroke at least 6 months and up to 5 years prior to study enrollment; - Unilateral upper extremity hemiparesis as characterized by initial scores on upper limb subtest of the Fugl-Meyer Assessment (FMA-UE) between 20 and 45; - Intact cognitive function to understand the study procedures and goal setting (MMSE score above 23 and able to follow 3 step command); - Being familiar and comfortable with the use of a tablet or smartphone. Exclusion Criteria: - Severe spasticity (defined as a Modified Ashworth scale score of 3 or more) that would prevent safe performance of UE tasks; - Visual impairments as assessed by the NIH Stroke Scale Visual Field subscale (only subjects with no visual loss will participate in the study); or hemispatial neglect that would impair the subject ability to see feedback on the app screen (as assessed with the star cancellation test); - Individuals with open wounds or recent fracture (less than 3 months) in the UE, fragile skin or active infection as evaluated by the study therapist; - Individuals currently enrolled in a UE rehabilitation program (i.e., OT, research study) - Upper-extremity orthopedic injuries or severe pain resulting in movement limitations; - Diagnosis of other neurological disease (i.e., Parkinson's disease, multiple sclerosis, ...); - Severe proprioceptive deficits that impair the ability to process the vibration feedback, as assessed by physical examination during screening as assessed by the study therapist; - Not understanding spoken or written English; - Recent (less than 3 months) Botox injection in the UE or plan to undergo injections during the study timeline; - Contralateral motor deficits as assessed by clinical examination; - Brainstem and cerebellar stroke.

Study Design


Related Conditions & MeSH terms


Intervention

Combination Product:
StrokeWear Motor and Behavioral Intervention
The intervention will consist of 1) the use of StrokeWear for goal directed movements (GDM) feedback and goal setting, 2) use of daily activity action planning (DAAP) to foster planned hemiparetic UE use during daily activities in the home and community, and 3) patient empowerment. Patient empowerment in this study will occur over 6-months as patients gain the ability to use the StrokeWear technology independently and develop skills to manage their GDM and DAAP.
Other:
Usual Care
The intervention will consist in a sham version of the StrokeWear system and usual clinical care under the direction of a clinician. The sham version of the StrokeWear system will include sensing and recording technology to detect GDMs. However, study participants will not receive feedback from the system regarding the GDM counts.

Locations

Country Name City State
United States Spaulding Rehabilitation Hospital Boston Boston Massachusetts

Sponsors (4)

Lead Sponsor Collaborator
Spaulding Rehabilitation Hospital BioSensics, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), MGH Institute of Health Professions

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Other Change in Canadian Occupational Performance Measure (COPM) Semi-structured interview to assess outcomes in the areas of self-care, productivity and leisure. Score from 0 (worst) to 10 (best). Change from baseline Canadian Occupational Performance Measure (COPM) score at 6 months
Other Number of times the activity goals are reached Number of times the activity goals set are reached over the study duration At 6 months
Primary Change in Motor Activity Log-Amount of Use Self-reported measure of upper-extremity performance. Score from 0 (worst) to 5 (best) Change from baseline Motor Activity Log-Amount of Use score at 6 months
Primary Change in Fugl-Meyer Upper-Extremity Observed measure of upper-extremity motor impairment following a stroke. Score from 0 (worst) to 66 (best) Change from baseline Fugl-Meyer Upper-Extremity score at 6 months
Primary Change in Upper-Extremity Activity Counts Activity of the hemiparetic upper-extremity in the home setting as measured with wrist-worn accelerometers Change from baseline Upper-Extremity Activity Counts score at 6 months
Secondary Change in Motor Activity Log-Quality of Use Self-reported measure of upper-extremity quality of use. Score from 0 (worst) to 5 (best) Change from baseline Motor Activity Log-Quality of Use score at 6 months
Secondary Change in Wolf-Motor Function Test - Time subscale Observed (timed) measure of upper-extremity function. Time from 0 to 120 seconds (maximum time allowed to attempt to perform a motor task) Change from baseline Wolf-Motor Function Test - Time subscale score at 6 months
Secondary Change in Wolf-Motor Function Test - Functional ability subscale Measure of upper-extremity quality of movement based on visual observation. Score from 0 (worst) to 5 (best) Change from baseline Wolf-Motor Function Test - Functional ability subscale score at 6 months
Secondary Change in Stroke Impact Scale (SIS) Self-reported measure of quality of life after a stroke. Score from 0 (best) to 42 (worst) Change from baseline Stroke Impact Scale (SIS) score at 6 months
Secondary Change in Stroke Self-Efficacy Questionnaire (SSEQ) - Activity subscale Self-reported measure of upper-extremity efficacy in activities of daily living. Score from 0 (worst) to 10 (best). Change from baseline Stroke Self-Efficacy Questionnaire (SSEQ) - Activity subscale score at 6 months
Secondary Change in Stroke Self-Efficacy Questionnaire (SSEQ) - Self-management subscale Self-reported measure of upper-extremity efficacy in activities of daily living. Score from 0 (worst) to 10 (best). Change from baseline Self-Efficacy Questionnaire (SSEQ) - Self-management subscale score at 6 months
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