Feasibility of a device to improve hand movement in patients with spasticity
Feasibility Study on Portable Rehabilitation (PoRi) Device in Hand Spasticity
This study is testing a new device that helps people with hand spasticity by moving their fingers to see if it can reduce muscle tightness.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 10 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Yale University Academic / other |
| Locations | 2 sites (New Haven, Connecticut and 1 other locations) |
| Trial ID | NCT06842901 on ClinicalTrials.gov |
What this trial studies
This study evaluates the feasibility of a new device designed to assist patients with hand spasticity by moving their fingers to reduce muscle tone. Participants will undergo a single 20-minute session where the device will flex and extend their finger muscles. The study will measure the effectiveness of the device by assessing the Modified Ashworth Score (MAS) before and after the intervention. The sessions will take place at Yale New Haven Hospital's outpatient clinic and inpatient rehabilitation unit.
Who should consider this trial
Good fit: Ideal candidates include adults with a Modified Ashworth Scale score of at least 1 and motor function issues in their fingers.
Not a fit: Patients who are minors, part of vulnerable populations, or unable to stretch their fingers and wrist to neutral may not benefit from this study.
Why it matters
Potential benefit: If successful, this device could significantly improve hand function and quality of life for patients with spasticity.
How similar studies have performed: While this approach is innovative, similar studies have shown promise in using devices for rehabilitation, indicating potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Modified Ashworth Scale (MAS) score of at least 1 * Participants with paralysis or motor function problems of the fingers of one or both hands. Exclusion Criteria: * Minors (below age 18) * Vulnerable populations * Inability of fingers and wrist to stretch to neutral during passive range of motion
Where this trial is running
New Haven, Connecticut and 1 other locations
- , Yale New Haven Hospital's Physical Medicine & Rehabilitation (PM&R) outpatient clinic — New Haven, Connecticut, United States (Recruiting)
- Yale New Haven Hospital's Inpatient Rehabilitation Unit — New Haven, Connecticut, United States (Recruiting)
Study contacts
- Principal investigator: Necolle Morgado-Vega — Yale University
- Study coordinator: Necolle Morgado-Vega
- Email: necolle.morgado-vega@yale.edu
- Phone: 203-843-5733
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.