Design of an Affordable Gym for Post Stroke Rehabilitation (RehabCares)

October 11, 2019 updated by: University of Pennsylvania
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.

Study Overview

Status

Completed

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

Observational

Enrollment (Actual)

20

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19146
        • Penn Medicine Rittenhouse

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Therapists and patients with neuro-rehab. Patients with neural injury

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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
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 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

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Michelle J Johnson, PhD, Penn Medicine Rittenhouse

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2015

Primary Completion (Actual)

August 1, 2019

Study Completion (Actual)

August 1, 2019

Study Registration Dates

First Submitted

June 16, 2016

First Submitted That Met QC Criteria

June 28, 2016

First Posted (Estimate)

July 1, 2016

Study Record Updates

Last Update Posted (Actual)

October 14, 2019

Last Update Submitted That Met QC Criteria

October 11, 2019

Last Verified

October 1, 2019

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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