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Behavioural Intervention

StrokeWear for Chronic Stroke Recovery

Phase 2
Waitlist Available
Led By Paolo Bonato, PhD
Research Sponsored by Spaulding Rehabilitation Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Intact cognitive function to understand the study procedures and goal setting (MMSE score above 23 and able to follow 3 step command)
Male or female, 18-85 years of age at the time of enrollment
Timeline
Screening 3 weeks
Treatment Varies
Follow Up change from baseline canadian occupational performance measure (copm) score at 6 months
Awards & highlights

Study Summary

This trial will study the effects of StrokeWear combined with home therapy on stroke recovery over 6 months.

Who is the study for?
This trial is for chronic stroke survivors aged 18-85 with mild to moderate arm weakness from a stroke that happened between 6 months and 5 years ago. They must be able to understand the study, use a tablet or smartphone, and not have severe spasticity, visual impairments preventing app use, other neurological diseases, severe proprioceptive deficits, recent fractures or wounds in the affected arm, current enrollment in another upper extremity rehab program.Check my eligibility
What is being tested?
The trial is testing StrokeWear system combined with home motor and behavioral interventions against usual care involving a home-exercise plan. Participants are randomly placed into either group for six months to see if StrokeWear improves their ability to use their affected arm in daily life.See study design
What are the potential side effects?
Since this intervention involves non-invasive technology and exercise routines rather than medication, side effects may include muscle soreness or fatigue due to increased activity levels but no drug-related side effects.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I can understand and follow study instructions well.
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I am between 18 and 85 years old.
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I have moderate weakness in one arm.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at 6 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and at 6 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in Fugl-Meyer Upper-Extremity
Change in Motor Activity Log-Amount of Use
Change in Upper-Extremity Activity Counts
Secondary outcome measures
Change in Motor Activity Log-Quality of Use
Change in Stroke Impact Scale (SIS)
Change in Stroke Self-Efficacy Questionnaire (SSEQ) - Activity subscale
+3 more
Other outcome measures
Change in Canadian Occupational Performance Measure (COPM)
Number of times the activity goals are reached

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: StrokeWear Motor and Behavioral InterventionExperimental Treatment1 Intervention
Group II: Usual CarePlacebo Group1 Intervention

Find a Location

Who is running the clinical trial?

Spaulding Rehabilitation HospitalLead Sponsor
134 Previous Clinical Trials
10,983 Total Patients Enrolled
25 Trials studying Stroke
977 Patients Enrolled for Stroke
MGH Institute of Health ProfessionsOTHER
15 Previous Clinical Trials
3,623 Total Patients Enrolled
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)NIH
1,963 Previous Clinical Trials
2,674,709 Total Patients Enrolled
79 Trials studying Stroke
5,355 Patients Enrolled for Stroke

Media Library

StrokeWear Motor and Behavioral Intervention (Behavioural Intervention) Clinical Trial Eligibility Overview. Trial Name: NCT05626894 — Phase 2
Stroke Research Study Groups: Usual Care, StrokeWear Motor and Behavioral Intervention
Stroke Clinical Trial 2023: StrokeWear Motor and Behavioral Intervention Highlights & Side Effects. Trial Name: NCT05626894 — Phase 2
StrokeWear Motor and Behavioral Intervention (Behavioural Intervention) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05626894 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any qualifications for potential participants of this clinical trial?

"This trial is aimed at 32 individuals aged 18-85, who had a stroke and are living with its consequences. The prerequisites for participation include: being of either gender; having suffered an anterior circulation ischemic stroke between 6 months to 5 years ago; displaying unilateral upper extremity hemiparesis (FMA-UE scores 20-45); possessing intact cognitive ability (MMSE score above 23) and capability of following 3 step commands; familiarity and comfort with the use of tablet or smartphone."

Answered by AI

What is the ultimate purpose of this research venture?

"The primary outcome, Change from Baseline Upper-Extremity Activity Counts Score at 6 Months Time Span, is quantified using the Motor Activity Log Amount of Use. Furthermore, this trial will be measuring other secondary outcomes including self-reported Quality of Use (0 to 5), observed function in a timed task (maximum 120 seconds), and Stroke Impact Scale scores (range 0 to 42)."

Answered by AI

Are individuals able to join this clinical exploration currently?

"As indicated on clinicaltrials.gov, the aforementioned trial is no longer recruiting candidates. The study was published in April of 2023 and last modified at the end of November 2022; however, there are currently 1070 additional trials that remain actively seeking patients to join their research."

Answered by AI

Has the Federal Drug Administration granted authorization for StrokeWear Motor and Behavioral Intervention?

"Due to the lack of efficacy data and some evidence for safety, StrokeWear Motor and Behavioral Intervention was given an estimation score of 2."

Answered by AI

Is the current clinical trial open to individuals less than 65 years of age?

"The requirements for enrolment stipulate that patients must be between the age of 18 and 85. Notably, 44 studies are accessible to those under 18 years old while 1028 trials are available for individuals over 65."

Answered by AI
~21 spots leftby Jun 2025