Digital Technology-Informed Stroke Rehabilitation
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Lab-based movement guidance, Home-based movement guidance.
- Who it may be relevant to
- Registry conditions: Stroke. Basic parameters: 30 years — 85 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Interventions
- Other Lab-based movement guidance
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. - Other Home-based movement guidance
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.
Primary outcome measures
- Kinematic movement quality score [Time frame: From enrollment to the end of treatment at 3 weeks.]
Secondary outcome measures (1)
- FMA-UE Score [Time frame: From enrollment to the end of treatment at 3 weeks.]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 1 center
- Kennecott Mechanical Engineering Building — Salt Lake City
Identifiers
NCT: NCT07698522 · IRB_00203244