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

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
Spaulding Rehabilitation Hospital
Study ID
NCT05626894
Phase
PHASE2
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 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.
  • 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.

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 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).

Key Dates

Start date
Mar 20, 2025
Status verified
Nov 2025
Primary completion
Jun 30, 2026
Completion
Sep 30, 2026

Study Design

Enrollment
32 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 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.

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 Hospital BostonBostonMassachusetts02129
Paolo Bonato, PhD
[email protected]
617-952-6319
Paolo Bonato, PhD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Boston, MA

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

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