- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07698522
Digital Technology-Informed Stroke Rehabilitation
The goal of this study is to determine the effects of lab and home-based technology guidance during movement training post-stroke. The study will compare movement training informed by lab-based technology to training delivered with technology at home. The main questions it aims to answer are:
- How well do lab and home-based technologies help individuals post-stroke improve their movement patterns?
- Is there a difference in improvement between the in-lab and at-home training groups?
- Which technologies lead to the most improvement?
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The study is a randomized, controlled feasibility trial investigating rehabilitation to improve movement patterns after stroke. The study will recruit participants who have had a stroke that led to upper-extremity impairment. Individuals will be assigned to one of two digital technology-guided groups. One group will be guided through exercises in a home-based setting, the other will be lab-based.
Participants will engage in training sessions multiple days a week for up to 6 weeks, either in-lab or at home. Both groups will visit the lab weekly for movement assessments.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Samantha McNeill
- Phone Number: (385) 215-9146
- Email: samantha.mcneill@utah.edu
Study Locations
-
-
Utah
-
Salt Lake City, Utah, United States, 84112
- Kennecott Mechanical Engineering Building
-
Contact:
- Scott Uhlrich, PhD
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Age between 30-85 years.
- Diagnosis of stroke.
- Stroke onset of at least six months prior to the time of participation.
- Fugl Meyer Upper Extremity between 30-50 (mild-moderate)
- Cognitive skills to consent and actively participate, as indicated by scores of ≥ 24 on the Mini- Mental Status Examination
- Able to visit lab up to 5x per week for 3 weeks
Exclusion Criteria:
- Presence of severe aphasia preventing the ability to follow 1-step directions at least 80% of the time.
- Excessive spasticity of the wrist, elbow, and shoulder, defined as a Modified Ashworth Score >2.
- Diagnosis of neurological disorders other than stroke.
- Orthopedic/musculoskeletal conditions (e.g., severe arthritis) affecting the upper extremity.
- Currently or planning to become pregnant.
- Participation in concurrent occupational therapy.
- Unilateral neglect, defined as failure of the Line Bisection Task
- Upper extremity pain >= 7/10 on Numeric Rating Scale
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: At-Home Training
Participants will train at-home.
|
Participants will receive computer-generated guidance on how to perform different activities of daily living efficiently.
This guidance will be delivered using home-based technologies, such as a computer or tablet.
|
|
Experimental: In-Lab Training
Participants will train in the lab.
|
Participants will receive computer-generated guidance on how to perform different activities of daily living efficiently.
The guidance will be delivered using lab-based sensing and feedback technology.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Kinematic movement quality score
Time Frame: From enrollment to the end of treatment at 3 weeks.
|
A score based on subject kinematics during a daily task (like reaching), comparing the subject's reaching kinematics to normative kinematics.
|
From enrollment to the end of treatment at 3 weeks.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
FMA-UE Score
Time Frame: From enrollment to the end of treatment at 3 weeks.
|
Upper Extremity Fugl-Meyer Score
|
From enrollment to the end of treatment at 3 weeks.
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Scott Uhlrich, PhD, University of Utah
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- IRB_00203244
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- ANALYTIC_CODE
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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