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

Primary Purpose

Stroke, Stroke Sequelae, Hemiparesis;Poststroke/CVA

Status
Not yet recruiting
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
StrokeWear Motor and Behavioral Intervention
Usual Care
Sponsored by
Spaulding Rehabilitation Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke focused on measuring StrokeWear, BioSensics, Behavioral intervention

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Spaulding Rehabilitation Hospital Boston

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

StrokeWear Motor and Behavioral Intervention

Usual Care

Arm Description

Outcomes

Primary Outcome Measures

Change in Motor Activity Log-Amount of Use
Self-reported measure of upper-extremity performance. Score from 0 (worst) to 5 (best)
Change in Fugl-Meyer Upper-Extremity
Observed measure of upper-extremity motor impairment following a stroke. Score from 0 (worst) to 66 (best)
Change in Upper-Extremity Activity Counts
Activity of the hemiparetic upper-extremity in the home setting as measured with wrist-worn accelerometers

Secondary Outcome Measures

Change in Motor Activity Log-Quality of Use
Self-reported measure of upper-extremity quality of use. Score from 0 (worst) to 5 (best)
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)
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)
Change in Stroke Impact Scale (SIS)
Self-reported measure of quality of life after a stroke. Score from 0 (best) to 42 (worst)
Change in Stroke Self-Efficacy Questionnaire (SSEQ) - Activity subscale
Self-reported measure of upper-extremity efficacy in activities of daily living. Score from 0 (worst) to 10 (best).
Change in Stroke Self-Efficacy Questionnaire (SSEQ) - Self-management subscale
Self-reported measure of upper-extremity efficacy in activities of daily living. Score from 0 (worst) to 10 (best).

Full Information

First Posted
November 6, 2022
Last Updated
May 10, 2023
Sponsor
Spaulding Rehabilitation Hospital
Collaborators
BioSensics, MGH Institute of Health Professions, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
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1. Study Identification

Unique Protocol Identification Number
NCT05626894
Brief Title
Novel Wrist Sensor System to Promote Hemiparetic Arm Use in Home Daily Life of Chronic Stroke Survivors
Official Title
A Novel Wrist Wearable Sensor System to Promote Hemiparetic Upper Extremity Use in Home Daily Life of Chronic Stroke Survivors
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
September 1, 2023 (Anticipated)
Primary Completion Date
June 30, 2025 (Anticipated)
Study Completion Date
September 30, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Spaulding Rehabilitation Hospital
Collaborators
BioSensics, MGH Institute of Health Professions, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Device Product Not Approved or Cleared by U.S. FDA
Yes
Product Manufactured in and Exported from the U.S.
No

5. Study Description

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 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).
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 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). 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke, Stroke Sequelae, Hemiparesis;Poststroke/CVA
Keywords
StrokeWear, BioSensics, Behavioral intervention

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
32 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
StrokeWear Motor and Behavioral Intervention
Arm Type
Experimental
Arm Title
Usual Care
Arm Type
Sham Comparator
Intervention Type
Combination Product
Intervention Name(s)
StrokeWear Motor and Behavioral Intervention
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Usual Care
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in Motor Activity Log-Amount of Use
Description
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
Title
Change in Fugl-Meyer Upper-Extremity
Description
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
Title
Change in Upper-Extremity Activity Counts
Description
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 Outcome Measure Information:
Title
Change in Motor Activity Log-Quality of Use
Description
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
Title
Change in Wolf-Motor Function Test - Time subscale
Description
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
Title
Change in Wolf-Motor Function Test - Functional ability subscale
Description
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
Title
Change in Stroke Impact Scale (SIS)
Description
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
Title
Change in Stroke Self-Efficacy Questionnaire (SSEQ) - Activity subscale
Description
Self-reported measure of upper-extremity efficacy in activities of daily living. Score from 0 (worst) to 10 (best).
Time Frame
Change from baseline Stroke Self-Efficacy Questionnaire (SSEQ) - Activity subscale score at 6 months
Title
Change in Stroke Self-Efficacy Questionnaire (SSEQ) - Self-management subscale
Description
Self-reported measure of upper-extremity efficacy in activities of daily living. Score from 0 (worst) to 10 (best).
Time Frame
Change from baseline Self-Efficacy Questionnaire (SSEQ) - Self-management subscale score at 6 months
Other Pre-specified Outcome Measures:
Title
Change in Canadian Occupational Performance Measure (COPM)
Description
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
Title
Number of times the activity goals are reached
Description
Number of times the activity goals set are reached over the study duration
Time Frame
At 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Paolo Bonato, PhD
Phone
617-952-6319
Email
pbonato@partners.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Paolo Bonato, PhD
Organizational Affiliation
Spaulding Rehabilitation Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Spaulding Rehabilitation Hospital Boston
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02129
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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

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