Recruiting
Phase 2

StrokeWear

Sponsor:

Spaulding Rehabilitation Hospital

Code:

NCT05626894

Conditions

Stroke

Stroke Sequelae

Hemiparesis;Poststroke/CVA

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

StrokeWear Motor and Behavioral Intervention

Usual Care

Study Details

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

Study ID

NCT05626894

Start date

Mar 20, 2025

Status verified date

Nov, 2025

Completion date

Sep 30, 2026

Anticipated

Primary completion date

Jun 30, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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

Enrollment

32 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: StrokeWear Motor and Behavioral Intervention

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.

sham comparator: Usual Care

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

Interventions

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.

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.

Primary outcome measure

  • Change in Motor Activity Log-Amount of Use [ Time Frame: Change from baseline Motor Activity Log-Amount of Use score at 6 months ]
  • Change in Fugl-Meyer Upper-Extremity [ Time Frame: Change from baseline Fugl-Meyer Upper-Extremity score at 6 months ]
  • Change in Upper-Extremity Activity Counts [ Time Frame: Change from baseline Upper-Extremity Activity Counts score at 6 months ]

Central Contacts and Locations

Central contacts

Paolo Bonato, PhD

617-952-6319pbonato@partners.org

Locations

Spaulding Rehabilitation Hospital Boston

Recruiting

Boston, Massachusetts, United States, 02129

Contacts

Paolo Bonato, PhD

617-952-6319pbonato@partners.org

Principal Investigator:

Paolo Bonato, PhD

More Information

Sponsor

Spaulding Rehabilitation Hospital

Last update posted

Nov 28, 2025

Last verified

Nov, 2025

Keywords

  • StrokeWear
  • BioSensics
  • Behavioral intervention

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Spaulding Rehabilitation Hospital on 2025-11-28.