Design of an Affordable Gym for Post Stroke Rehabilitation

Healthy Clinical Trial

— RehabCares  

Official title:

Design of an Affordable Gym for Post Stroke Rehabilitation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02820480
• Other study ID #: 823778
• Status: Completed
• Start date: November 2015
• Est. completion date: August 2019

Study information

• Verified date: October 2019
• Source: University of Pennsylvania
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: August 2019
• Est. primary completion date: August 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Cerebral Palsy
• Healthy
• Stroke

Intervention

Device:
• Rehab in a Crate System
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.

Locations

Country	Name	City	State
United States	Penn Medicine Rittenhouse	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
University of Pennsylvania

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Acceptability of Rehab system	The ability to accept the product for use in rehab; An ethnographic survey/questionnaire will be administered to the subjects.	1 session, about 1.5 hours in length
Secondary	Usability of Rehab System	The ability to use the product for therapy as intended	1 session, about 1.5 hours in length