NCT02820480

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Nov 2015

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2015

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

June 16, 2016

Completed
15 days until next milestone

First Posted

Study publicly available on registry

July 1, 2016

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2019

Completed
Last Updated

October 14, 2019

Status Verified

October 1, 2019

Enrollment Period

3.8 years

First QC Date

June 16, 2016

Last Update Submit

October 11, 2019

Conditions

Keywords

strokerehabilitationroboticscerebral palsytherapy

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Usability of Rehab System

    1 session, about 1.5 hours in length

Study Arms (1)

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.

Device: Rehab in a Crate System

Interventions

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.

Patients/health professionals

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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.

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Penn Medicine Rittenhouse

Philadelphia, Pennsylvania, 19146, United States

Location

MeSH Terms

Conditions

StrokeCerebral Palsy

Interventions

Rehabilitation

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesBrain Damage, Chronic

Intervention Hierarchy (Ancestors)

AftercareContinuity of Patient CarePatient CareTherapeuticsHealth ServicesHealth Care Facilities Workforce and Services

Study Officials

  • Michelle J Johnson, PhD

    Penn Medicine Rittenhouse

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 16, 2016

First Posted

July 1, 2016

Study Start

November 1, 2015

Primary Completion

August 1, 2019

Study Completion

August 1, 2019

Last Updated

October 14, 2019

Record last verified: 2019-10

Data Sharing

IPD Sharing
Will not share

Locations