Clinical trial NCT06797154: A Novel Wrist Wearable Sensor System to Promote Hemiparetic Upper Extremity Use in Subacute Stroke Survivors
Official title: A Novel Wrist Wearable Sensor System to Promote Hemiparetic Upper Extremity Use in Home Daily Life of Subacute Stroke Survivors
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Stroke
Stroke Sequelae
Hemiparesis;Poststroke/CVA
Keywords: StrokeWear
Biosensics
Behavioral Intervention
Lead sponsor: Spaulding Rehabilitation Hospital
Sponsor class: OTHER
Collaborators: name: BioSensics
name: MGH Institute of Health Professions
name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
First posted: 2025-01-28
Enrollment: 88
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

Detailed description: 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).

Study participants will be asked to take part in 4 evaluation study visits: one screening and enrollment visit, and three evaluation visits (at baseline, at 3 months and at 6 months - at the intervention completion). Subject upper-extremity motor function will be assessed across domains of the International Classification of Functioning, Disability and Health (ICF) model. Groups will be stratified by baseline motor impairment and stroke chronicity.

Subjects randomized to the intervention group will take part of weekly coaching sessions during the first month, bi-weekly sessions during the months 2 and 3, and monthly sessions during months 4-6. These sessions will be held in-person or remotely, based on the study participant preference.

Subjects randomized to the control group will take part of monthly visits, held in-person or remotely (based on study participant preference), to re-evaluate the home-exercise plan and prescribe an update list of exercises for the following month.

Eligibility criteria: Inclusion Criteria:

* 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

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 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.

Primary outcomes:
measure: Change in Motor Activity Log-Amount of Use
timeFrame: Change from baseline Motor Activity Log-Amount of Use score at 6 months
measure: Change in Fugl-Meyer Upper-Extremity
timeFrame: Change from baseline Fugl-Meyer Upper-Extremity score at 6 months
measure: Change in Upper-Extremity Activity Counts
timeFrame: Change from baseline Upper-Extremity Activity Counts score at 6 months
Secondary outcomes:
measure: Change in Motor Activity Log-Quality of Use
timeFrame: Change from baseline Motor Activity Log-Quality of Use score at 6 months
measure: Change in Wolf-Motor Function Test - Time subscale
timeFrame: Change from baseline Wolf-Motor Function Test - Time subscale score at 6 months
measure: Change in Wolf-Motor Function Test - Functional ability subscale
timeFrame: Change from baseline Wolf-Motor Function Test - Functional ability subscale score at 6 months
measure: Change in Stroke Impact Scale (SIS)
timeFrame: Change from baseline Stroke Impact Scale (SIS) score at 6 months
measure: Change in Stroke Self-Efficacy Questionnaire (SSEQ) - Activity subscale
timeFrame: Change from baseline Stroke Self-Efficacy Questionnaire (SSEQ) - Activity subscale score at 6 months
measure: Change in Stroke Self-Efficacy Questionnaire (SSEQ) - Self-management subscale
timeFrame: Change from baseline Self-Efficacy Questionnaire (SSEQ) - Self-management subscale score at 6 months
Other outcomes:
measure: Number of times the activity goals are reached
timeFrame: At 6 months
Locations:
city: Boston
country: United States
facility: Spaulding Rehabilitation Hospital
state: Massachusetts
Study officials:
affiliation: Spaulding Rehabilitation Hospital
name: Paolo Bonato, PhD
role: PRINCIPAL_INVESTIGATOR
References: