Digital Technology-Informed Stroke Rehabilitation
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- University of Utah
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- Kinematic movement quality score
Study Overview
Brief Summary
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?
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 30 Years to 85 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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 >
- •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
Arms & Interventions
In-Lab Training
Participants will train in the lab.
Intervention: Lab-based movement guidance (Other)
At-Home Training
Participants will train at-home.
Intervention: Home-based movement guidance (Other)
Outcomes
Primary Outcomes
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.
Secondary Outcomes
- FMA-UE Score(From enrollment to the end of treatment at 3 weeks.)
Investigators
Scott Uhlrich
Assistant Professor
University of Utah