Ignite Creation Date:
2025-12-25 @ 1:35 AM
Ignite Modification Date:
2026-01-03 @ 10:13 PM
Study NCT ID:
NCT05626894
Status:
RECRUITING
Last Update Posted:
2025-11-28
First Post:
2022-11-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Novel Wrist Sensor System to Promote Hemiparetic Arm Use in Home Daily Life of Chronic Stroke Survivors
Sponsor:
Spaulding Rehabilitation Hospital
Organization:
Study Overview
Official Title:
A Novel Wrist Wearable Sensor System to Promote Hemiparetic Upper Extremity Use in Home Daily Life of Chronic Stroke Survivors
Status:
RECRUITING
Status Verified Date:
2025-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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.
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
True
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| R44HD084035 | NIH | None | https://reporter.nih.gov/quic… | View |