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

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
Spaulding Rehabilitation Hospital
Study ID
NCT06797154
Status
Recruiting
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Conditions

  • Hemiparesis;Poststroke/CVA
  • Stroke
  • Stroke Sequelae

Eligibility Criteria

Sex
ALL
Age
18 Years - 85 Years
Healthy Volunteers
Not accepted

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.
  • 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.

Study Details

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).

Key Dates

Start date
Aug 8, 2025
Status verified
Nov 2025
Primary completion
Jun 30, 2026
Completion
Aug 31, 2026

Study Design

Enrollment
88 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: StrokeWear Motor and Behavioral Intervention
    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.
  • Other: Sham Comparator: Usual Care
    Stroke survivors randomized to this group will receive standard rehabilitation (i.e., physical and occupational therapy).

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 ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Spaulding Rehabilitation HospitalBostonMassachusetts02129
Paolo Bonato, PhD
[email protected]
617-952-6319

Find similar trials in Boston, MA

By condition
Stroke
By specialty
NeurologyBrain disorders
By research site
Spaulding Rehabilitation Hospital· Boston, MA

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