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

ConditionsStroke Stroke Sequelae Hemiparesis;Poststroke/CVA

Trial statusRecruiting

Trial phasePhase 2

Trial typeInterventional

Biological sexAll

Age18-85

SponsorSpaulding Rehabilitation Hospital

About this trial

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).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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);

Disqualifiers

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)

Trial design

Design model

Parallel

Treatments tested in this trial

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 intervention
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.

Treatment groups

32 Participants

are divided into 2 treatment groups

Group A: StrokeWear Motor and Behavioral InterventionExperimental treatment 1 intervention

Group B: Usual CareSham comparator 1 intervention

Trial outcomes

Primary outcomes

Change in Motor Activity Log-Amount of Use

Self-reported measure of upper-extremity performance. Score from 0 (worst) to 5 (best)

Time frame

Change from baseline Motor Activity Log-Amount of Use score at 6 months

Change in Fugl-Meyer Upper-Extremity

Observed measure of upper-extremity motor impairment following a stroke. Score from 0 (worst) to 66 (best)

Time frame

Change from baseline Fugl-Meyer Upper-Extremity score at 6 months

Change in Upper-Extremity Activity Counts

Activity of the hemiparetic upper-extremity in the home setting as measured with wrist-worn accelerometers

Time frame

Change from baseline Upper-Extremity Activity Counts score at 6 months

Secondary outcomes

Change in Motor Activity Log-Quality of Use

Self-reported measure of upper-extremity quality of use. Score from 0 (worst) to 5 (best)

Time frame

Change from baseline Motor Activity Log-Quality of Use score at 6 months

Change in Wolf-Motor Function Test - Time subscale

Observed (timed) measure of upper-extremity function. Time from 0 to 120 seconds (maximum time allowed to attempt to perform a motor task)

Time frame

Change from baseline Wolf-Motor Function Test - Time subscale score at 6 months

Change in Wolf-Motor Function Test - Functional ability subscale

Measure of upper-extremity quality of movement based on visual observation. Score from 0 (worst) to 5 (best)

Time frame

Change from baseline Wolf-Motor Function Test - Functional ability subscale score at 6 months

Change in Stroke Impact Scale (SIS)

Self-reported measure of quality of life after a stroke. Score from 0 (best) to 42 (worst)

Time frame

Change from baseline Stroke Impact Scale (SIS) score at 6 months

Other outcomes

Change in Canadian Occupational Performance Measure (COPM)

Semi-structured interview to assess outcomes in the areas of self-care, productivity and leisure. Score from 0 (worst) to 10 (best).

Time frame

Change from baseline Canadian Occupational Performance Measure (COPM) score at 6 months

Number of times the activity goals are reached

Number of times the activity goals set are reached over the study duration

Time frame

At 6 months

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Spaulding Rehabilitation Hospital

Lead sponsor

BioSensics

Collaborator

MGH Institute of Health Professions

Collaborator

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Collaborator

Source ClinicalTrials.gov

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