Design of an Affordable Gym for Post Stroke Rehabilitation

Completed

• Conditions: Stroke; Cerebral Palsy; Healthy
• Interventions: Device: Rehab in a Crate System

• Registration Number: NCT02820480
• Lead Sponsor: University of Pennsylvania

Brief Summary

Rehab in a Crate is a therapy gym designed to be affordable, compact and easily transportable. The purpose of this particular study is to gain feedback on the initial design of the Rehab in a Crate system. This will be accomplished by using qualitative ethnographic research methods (i.e. human centered design) in the form of surveys that have been carefully designed by members of the research team. The eligibility criteria of this survey research reflects the intended user base of an eventual finished product, which is survivors of stroke and cerebral palsy across the globe. And while healthcare professionals are not the user base per se, their expertise and feedback should be instrumental in the design of future iterations of the Rehab in a Crate. Ease of use, utility, design, and various features, both existing and intended, will all be surveyed items.

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 Timeline

• Study Start: 2015-11
• Study First Submitted: 2016-06-16
• Study First Submitted QC: 2016-06-28
• Study First Posted: 2016-07-01
• Primary Completion: 2019-08
• Study Completion: 2019-08
• Status Verified: 2019-10
• Last Update Submitted: 2019-10-11
• Last Update Posted: 2019-10-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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.

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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).

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients/health professionals	Rehab in a Crate System	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.

Primary Outcome Measures

Name	Time	Method
Acceptability of Rehab system	1 session, about 1.5 hours in length	The ability to accept the product for use in rehab; An ethnographic survey/questionnaire will be administered to the subjects.

Secondary Outcome Measures

Name	Time	Method
Usability of Rehab System	1 session, about 1.5 hours in length	The ability to use the product for therapy as intended

Trial Locations

Locations (1)

Penn Medicine Rittenhouse; 🇺🇸 Philadelphia, Pennsylvania, United States