- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02820480
Design of an Affordable Gym for Post Stroke Rehabilitation (RehabCares)
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The investigators aim to survey stroke survivors and healthcare professionals on the design, ease of use, utility, and various features of, both existing and those yet-to-be-developed. This feedback will help to fine tune further development of this therapy gym, Rehab in a Crate, and move forward in the iteration process.
Note: The device is not being used at this moment for diagnostic or evaluation.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Pennsylvania
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Philadelphia, Pennsylvania, United States, 19146
- Penn Medicine Rittenhouse
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Stroke survivors who are more than 3 months post stroke and persons with cerebral palsy adults - have hemiplegia or diplegia
- Health professionals who have considerable experience in stroke rehabilitation.
Exclusion Criteria:
- Anyone who is not 18 years of age.
- More than mild spasticity in the upper of lower extremities.
- A cognitive score on the Montreal Cognitive Assessment that indicates that the participant is cognitively impaired.
- Motor impairment that precludes interaction with the Rehab in a Crate (e.g. unable to grip a handle).
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Patients/health professionals
Stroke AND cerebral palsy PATIENTS: greater than 18 years of age, who are more than 3 months post stroke, as well as health professionals who have considerable experience in stroke rehabilitation will be asked to evaluate the design of the Rehab in a Crate system.
The aim is to survey stroke survivors and healthcare professionals on the design, ease of use, utility, and various features of, both existing and those yet-to-be-developed.
|
The therapy gym is Rehab in a Crate with 4 stations for upper and lower limb assessment/therapy. Each station will allow adaptive game-based therapy. Note: The device is not being used at this moment for diagnostic or evaluation. Users will be asked to explore the device, try the systems, and provide feedback about use. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Acceptability of Rehab system
Time Frame: 1 session, about 1.5 hours in length
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The ability to accept the product for use in rehab; An ethnographic survey/questionnaire will be administered to the subjects.
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1 session, about 1.5 hours in length
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Usability of Rehab System
Time Frame: 1 session, about 1.5 hours in length
|
The ability to use the product for therapy as intended
|
1 session, about 1.5 hours in length
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Michelle J Johnson, PhD, Penn Medicine Rittenhouse
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 823778
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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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