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

Mass General Brigham

Status and phase

Enrolling

Phase 2

Conditions

Hemiparesis;Poststroke/CVA

Stroke

Stroke Sequelae

Treatments

Other: Usual Care

Combination Product: StrokeWear Motor and Behavioral Intervention

Study type

Interventional

Funder types

Other

Industry

NIH

Identifiers

NCT05626894

2022P002943

R44HD084035 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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).

Full description

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.

Enrollment

32 estimated patients

Sex

All

Ages

18 to 85 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

32 participants in 2 patient groups

StrokeWear Motor and Behavioral Intervention

Experimental group

Description:

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.

Treatment:

Combination Product: StrokeWear Motor and Behavioral Intervention

Usual Care

Sham Comparator group

Description:

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

Treatment:

Other: Usual Care