StrokeRehabCaresNCT02820480
Design of an Affordable Gym for Post Stroke Rehabilitation
An observational study of Stroke and Cerebral Palsy, run by University of Pennsylvania at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Stroke, Cerebral Palsy, Healthy
- What is being tested?
- Rehab in a Crate System
- Type of treatment
- Medical device
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2015to Aug 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Therapists and patients with neuro-rehab. Patients with neural injury
Who may be able to join
- 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.
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
United States1 site
Penn Medicine Rittenhouse
Philadelphia, Pennsylvania, 19146
About this study
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.
Read the 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.
- Conditions
- Stroke, Cerebral Palsy, Healthy
- Being tested
- Rehab in a Crate System
- Keywords
- stroke, rehabilitation, robotics, cerebral palsy, therapy
- Medical subject headings
- Stroke, Cerebral Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rehab in a Crate SystemDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Rehab in a Crate System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acceptability of Rehab system
The ability to accept the product for use in rehab; An ethnographic survey/questionnaire will be administered to the subjects.
Measured: 1 session, about 1.5 hours in length
Secondary outcomes (1)
Usability of Rehab System
The ability to use the product for therapy as intended
Measured: 1 session, about 1.5 hours in length
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2016 (estimated)
- Study startNov 2015
- Primary completionAug 2019
- Study completionAug 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- More trials run by University of PennsylvaniaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Michelle J Johnson, PhD, Principal investigator, Penn Medicine Rittenhouse
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02820480
- Sponsor's protocol ID
- 823778
- Acronym
- RehabCares
- Status last verified
- Oct 2019
- First submitted
- 16 Jun 2016
- Last updated
- 14 Oct 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Design of an Affordable Gym for Post Stroke Rehabilitation
- ClinicalTrials.gov ID
- NCT02820480
- Acronym / sponsor ID
- RehabCares / 823778
- Conditions
- Stroke, Cerebral Palsy, Healthy
- Keywords
- stroke, rehabilitation, robotics, cerebral palsy, therapy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Study start
- Nov 2015
- Primary completion
- Aug 2019 (actual)
- Study completion
- Aug 2019 (actual)
- First posted
- 1 Jul 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients/health professionals | – | Device: Rehab in a Crate SystemStroke 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Therapists and patients with neuro-rehab. Patients with neural injury
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (4 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Rehab in a Crate SystemThe 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. | Device | Patients/health professionals |
Primary outcome
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 secondary outcome
Usability of Rehab System
Time frame: 1 session, about 1.5 hours in length
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Oct 2019.
- Individual participant dataSharing planned: No
Related trials for Stroke
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Web-Based Tele-Rehabilitation Using Action Observation and Mirror Therapy for Subacute Stroke: A Randomized Controlled Trial
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michelle J Johnson, PhD principal investigator
Penn Medicine Rittenhouse
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Stroke and Cerebral Palsy, run by University of Pennsylvania at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Acceptability of Rehab system (time frame: 1 session, about 1.5 hours in length). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Oct 2019.