A device to improve sitting posture and balance for individuals with spinal cord injuries
A Neuroprosthesis for Seated Posture and Balance
This study is testing a new device that helps people with spinal cord injuries sit better and improve their balance by using electrical stimulation to strengthen their muscles.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 10 (estimated) |
| Ages | 21 Years and up |
| Sex | All |
| Sponsor | VA Office of Research and Development Federal |
| Locations | 1 site (Cleveland, Ohio) |
| Trial ID | NCT01474148 on ClinicalTrials.gov |
What this trial studies
This study evaluates a surgically implanted functional electrical stimulation (FES) system designed to enhance trunk and hip stability in individuals with spinal cord injuries. The procedure involves inserting electrodes into the trunk and hip muscles, which are connected to a stimulator located in the abdomen. After a recovery period, participants will undergo training to use the neuroprosthesis, and their strength, balance, and functional abilities will be assessed both with and without the device. The goal is to determine how FES can improve daily activities such as sitting, breathing, and mobility.
Who should consider this trial
Good fit: Ideal candidates are individuals with spinal cord injuries at the C4-T12 level, who have some muscle function and are at least six months post-injury.
Not a fit: Patients who are pregnant or do not speak English may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly enhance the quality of life for patients with spinal cord injuries by improving their stability and functional independence.
How similar studies have performed: Other studies using functional electrical stimulation have shown promise in improving mobility and function in similar patient populations.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * C4-T12 * ASIA Scale A through C * Time post injury greater than 6 months * Innervated and excitable trunk and pelvis musculature * Absence of acute or chronic psychological problems or chemical dependency * Range of motion within normal limits * Controlled spasticity and absence of hip flexion and adduction spasm * Height and weight within normal limits * No history of balance problems or spontaneous falls * No history of spontaneous fracture or evidence low bone density * No acute orthopaedic problems * No acute medical complications * Adequate social support and stability * Able to speak and read English Exclusion Criteria: * Pregnancy * Non-English speaking
Where this trial is running
Cleveland, Ohio
- Louis Stokes VA Medical Center, Cleveland, OH — Cleveland, Ohio, United States (Recruiting)
Study contacts
- Principal investigator: Ronald Triolo, PhD — Louis Stokes VA Medical Center, Cleveland, OH
- Study coordinator: Lisa M Lombardo, MPT
- Email: Lisa.Lombardo2@va.gov
- Phone: (216) 791-3800
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.