A Novel Wrist Wearable Sensor System to Promote Hemiparetic Upper Extremity Use in Subacute Stroke Survivors

NCT06797154 | Recruiting

• 2 other identifiers: 2024P003622R44HD084035
• Study Type: interventional
• Target: 88
• 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 subacute 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 (1)

• 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 rehabilitation (i.e., physical and occupational therapy) as well as a behavioral intervention aimed to encourage the use of the stroke affected arm during the performance of activities of daily living.

Behavioral: StrokeWear Behavioral Intervention

Sham Comparator: Usual Care

OTHER

Stroke survivors randomized to this group will receive standard rehabilitation (i.e., physical and occupational therapy).

Other: Usual Care + Sham

Interventions

StrokeWear Behavioral Intervention BEHAVIORAL

Behavioral strategies will be incorporated into the Strokewear system to encourage feedback on behavior, goal setting, daily activity action planning (DAAP), and an empowerment/ self management model to foster planned hemiparetic UE use during daily activities in the home and community. 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 self- manage their GDM and DAAP.

StrokeWear Motor and Behavioral Intervention

Usual Care + Sham 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.

Sham Comparator: 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 1 month and no more than 6 months 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 3step command) ;
• Owning a smartphone (iOS or Android) and being familiar and comfortable with and owning a tablet or smartphone
• SAFE score equal or greater than 5

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 the feedback on the app screen (as assessed with the Mesulum cancellation test);
• Individuals with open wounds or recent fracture (less than 3 months) in the upper extremity, fragile skin or active infection;
• 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;
• Not understanding spoken or written English;
• 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, Massachusetts, 02129, United States

RECRUITING

MeSH Terms

Conditions

Stroke

Interventions

salicylhydroxamic acid

Condition Hierarchy (Ancestors)

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

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: not applicable
• 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: January 21, 2025
• First Posted: January 28, 2025
• Study Start: August 8, 2025
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): August 31, 2026
• Last Updated: November 28, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)