Novel Wrist Sensor System to Promote Hemiparetic Arm Use in Home Daily Life of Chronic Stroke Survivors

NCT05626894 | Recruiting Phase 2 FDA Device

• 2 other identifiers: 2022P002943R44HD084035
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Stroke; Stroke Sequelae; Hemiparesis;Poststroke/CVA

Keywords

StrokeWear; BioSensics; Behavioral intervention

Outcome Measures

Primary Outcomes (3)

• 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

• 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

• 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 Outcomes (6)

• Change in Motor Activity Log-Quality of Use

  Change from baseline Motor Activity Log-Quality of Use score at 6 months

• Change in Wolf-Motor Function Test - Time subscale

  Change from baseline Wolf-Motor Function Test - Time subscale score at 6 months

• Change in Wolf-Motor Function Test - Functional ability subscale

  Change from baseline Wolf-Motor Function Test - Functional ability subscale score at 6 months

• Change in Stroke Impact Scale (SIS)

  Change from baseline Stroke Impact Scale (SIS) score at 6 months

• Change in Stroke Self-Efficacy Questionnaire (SSEQ) - Activity subscale

  Change from baseline Stroke Self-Efficacy Questionnaire (SSEQ) - Activity subscale score at 6 months

Other Outcomes (2)

• Change in Canadian Occupational Performance Measure (COPM)

  Change from baseline Canadian Occupational Performance Measure (COPM) score at 6 months

• Number of times the activity goals are reached

  At 6 months

Study Arms (2)

StrokeWear Motor and Behavioral Intervention

EXPERIMENTAL

Stroke survivors randomized to this group will receive standard occupational and physical therapy in addition to a behavioral intervention aimed to encourage stroke survivors to use their affect arm during the performance of activities of daily living.

Combination Product: StrokeWear Motor and Behavioral Intervention

Usual Care

SHAM COMPARATOR

Stroke survivors randomized to this group will receive standard occupational and physical therapy.

Other: Usual Care

Interventions

StrokeWear Motor and Behavioral Intervention COMBINATION_PRODUCT

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.

StrokeWear Motor and Behavioral Intervention

Usual Care OTHER

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.

Usual Care

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Spaulding Rehabilitation Hospital: lead
• BioSensics: collaborator
• MGH Institute of Health Professions: collaborator
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator

Study Sites (1)

Spaulding Rehabilitation Hospital Boston

Boston, Massachusetts, 02129, United States

RECRUITING

MeSH Terms

Conditions

Stroke

Interventions

Behavior Therapy

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Paolo Bonato, PhD

  Spaulding Rehabilitation Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Paolo Bonato, PhD

CONTACT

617-952-6319; pbonato@partners.org

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Motion Analysis Laboratory

Study Record Dates

• First Submitted: November 6, 2022
• First Posted: November 25, 2022
• Study Start: March 20, 2025
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): September 30, 2026
• Last Updated: November 28, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)