Hybrid robot and electrical stimulation for stroke rehabilitation
Assessment Followed by Home-based Hybrid Robot + FES Rehabilitation Post-stroke
This study is testing a new way to help stroke survivors recover by using a robot for stretching along with electrical stimulation to see if it improves their movement and muscle strength.
Quick facts
| Phase | Phase1; Phase2 |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 18 Years to 85 Years |
| Sex | All |
| Sponsor | University of Maryland, Baltimore Academic / other |
| Locations | 1 site (Baltimore, Maryland) |
| Trial ID | NCT04550728 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates a novel rehabilitation approach for stroke survivors that combines robot-guided stretching with functional electrical stimulation (FES) to enhance motor recovery. The study aims to improve joint range of motion, reduce spasticity, and increase muscle force output through a hybrid system that integrates robotic training and FES. Participants will be randomly assigned to receive either ankle robot training alone or in combination with FES, primarily in a home-based setting. The goal is to translate advanced rehabilitation technologies from the lab to everyday use for stroke patients.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18-85 who are at least six months post-stroke and can ambulate at least 10 meters with or without assistance.
Not a fit: Patients with severe pain in the paralyzed lower limb or those with implanted electronic devices may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly enhance motor recovery and functional independence for stroke survivors.
How similar studies have performed: While the combination of robotic training and FES is a novel approach, similar studies have shown promise in enhancing rehabilitation outcomes for neurological conditions.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age 18-85; * Able to ambulate at least 10 meters without human assistance, with or without an assistive device * ≥ 6 months post stroke; * having a caregiver to assist in training at home. Exclusion Criteria: * having expressive and receptive aphasia; * an inability to follow multi-step commands; * enrolled in another lower limb rehabilitation program; * having severe pain in the paralyzed lower-limb; * \>30º ankle plantar flexion contracture; * Having implanted electronic device such as a pacemaker, spinal cord, or deep brain stimulator because FES may potentially interfere with their functions.
Where this trial is running
Baltimore, Maryland
- University of Maryland School of Medicine — Baltimore, Maryland, United States (Recruiting)
Study contacts
- Study coordinator: Li-qun Zhang, PhD
- Email: L-Zhang@som.umaryland.edu
- Phone: 410 706 2145
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.