Community-based rehabilitation for stroke patients using robot-assisted therapy
Rehabilitation Using Community-Based Affordable Robotic Exercise Systems (Rehab CARES)
This study is testing if a new robot-assisted therapy can help stroke patients recover better than standard care in their community.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 36 (estimated) |
| Ages | 55 Years and up |
| Sex | All |
| Sponsor | University of Pennsylvania Academic / other |
| Locations | 2 sites (Philadelphia, Pennsylvania and 1 other locations) |
| Trial ID | NCT05542121 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the effectiveness of a robot-assisted therapy system called Rehab CARES for stroke patients in a community-based setting. Patients will undergo a series of clinical assessments before and after receiving either standard care or therapy using the robot system over a four-week period. The study aims to determine the safety, feasibility, and functional outcomes of the robot therapy compared to traditional methods, while also assessing patient motivation and cost-effectiveness. The trial will involve 36 participants who will be randomized into two groups: one receiving standard care and the other receiving robot-assisted therapy.
Who should consider this trial
Good fit: Ideal candidates are individuals aged 55 and older who are more than three months post-stroke and have hemiparesis.
Not a fit: Patients with severe cognitive impairment or those without cerebellum lesions due to stroke may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could enhance rehabilitation outcomes for stroke patients and improve access to quality care in low-resource settings.
How similar studies have performed: Other studies have shown promise with robot-assisted therapies in rehabilitation, indicating potential for success in this novel approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age 55 and older (based on who is admitted to the CBR site) * \>3 months post-stroke * Stroke diagnosis * Diagnosis of hemiparesis as a result of stroke (verified by radiology data) * Motor control score on Upper Extremity Fugl-Meyer scale \> 15 and \< 60; * Able to understand and speak * Upper arm manual muscle strength scores \>1 * Pain Scores \< 8 based on NIH Pain Intensity Scale Exclusion Criteria: * no cerebellum lesions due to stroke * severe cognitive function
Where this trial is running
Philadelphia, Pennsylvania and 1 other locations
- Mercy Living Independently for Elders (L.I.F.E) - West Philadelphia — Philadelphia, Pennsylvania, United States (Not_yet_recruiting)
- Penn Medicine Rittenhouse — Philadelphia, Pennsylvania, United States (Recruiting)
Study contacts
- Principal investigator: Michelle J Johnson, PhD — University of Pennsylvania
- Study coordinator: Pamela Z Cacchione, PhD, RN
- Email: pamelaca@nursing.upenn.edu
- Phone: 215-259-0428
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.