Implanted electrical stimulation of the trunk for seated postural stability and function after cervical spinal cord injury: a single case study.
Ronald J Triolo, Lisa Boggs, Michael E Miller...
https://pubmed.ncbi.nlm.nih.gov/19236990Actively Recruiting
Phase Not Applicable
Age: 21Years +
All Genders
ID01474148
A Neuroprosthesis for Seated Posture and Balance
Led by VA Office of Research and Development · Updated on 2025-10-27
10
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying a surgically implanted functional electrical stimulation (FES) system designed to improve stability of the trunk and hips in people with spinal cord injuries, paralysis, tetraplegia, or paraplegia. This system uses small electric currents to make muscles contract, aiming to help users sit more steadily, breathe better, reach farther, push a wheelchair, or roll in bed. The study is conducted by the VA Office of Research and Development and focuses on how this neuroprosthesis affects posture and mobility. The study involves one surgical procedure to implant electrodes into the trunk and hip muscles. These electrodes connect to an 8-channel stimulator implanted in the abdomen. After surgery, participants spend two to six weeks at home with limited activity to allow healing. Following this, they undergo exercise and training to begin using the neuroprosthesis functionally. Participants will be assessed in the lab for strength, balance, and functional abilities both with and without the system, while the implanted device’s technical performance is also monitored. Participants will be involved for up to 36 months, during which researchers will measure the effects of trunk stimulation on posture control, breathing, pressure distribution while seated, reach ability, stability, and personal mobility. They will also work on designing a simple position controller. The study includes post-operative training and follow-up visits to track progress, device function, and safety over time.
CONDITIONS
Brief Title
A Neuroprosthesis for Seated Posture and Balance
Who Can Participate
Age: 21Years +
All Genders
Eligibility Criteria
You may qualify if you...
- Spinal cord injury between C4 and T12 levels
- ASIA Scale classification A through C
- Injury occurred more than 6 months ago
- Innervated and excitable trunk and pelvis muscles
- No acute or chronic psychological problems or chemical dependency
- Normal range of motion
- Controlled spasticity without hip flexion or adduction spasms
- Height and weight within normal limits
- No history of balance problems or spontaneous falls
- No history of spontaneous fractures or low bone density
- No acute orthopedic problems
- No acute medical complications
- Adequate social support and stability
- Ability to speak and read English
You will not qualify if you...
- Pregnancy
- Non-English speaking
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Surgery and Immediate Post-operative Care
Duration - 2 to 5 days
Participants undergo a single surgical procedure to implant the neuroprosthesis, followed by 2 to 5 days of post-operative care in the hospital to promote healing.
Hospital stay for surgery and immediate recovery
Post-operative Follow-up
Duration - 2 to 6 weeks
After hospital discharge, participants have 2 to 6 weeks of restricted activity to promote healing of surgical incisions, followed by exercise and training for functional use of the neuroprosthesis.
Multiple follow-up visits during recovery and training period
Treatment
Duration - Up to 36 months
Participants use the implanted neuroprosthesis for trunk and hip muscle stimulation to improve seated posture, balance, and functional abilities.
Regular laboratory assessments of strength, balance, and functional abilities
Trial Site Locations
Total: 1 location
1
Louis Stokes VA Medical Center, Cleveland, OH
Cleveland, Ohio, United States, 44106-1702
Actively Recruiting
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Research Team
L
Lisa M Lombardo, MPT
E
Emily C Johnson, BA
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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Published Research Related To This Trial
Effects of regular use of neuromuscular electrical stimulation on tissue health.
Kath M Bogie, Ronald J Triolo
https://pubmed.ncbi.nlm.nih.gov/15077659Sudden stop detection and automatic seating support with neural stimulation during manual wheelchair propulsion.
Kevin M Foglyano, Lisa M Lombardo, John R Schnellenberger...
https://pubmed.ncbi.nlm.nih.gov/32795162Automatic application of neural stimulation during wheelchair propulsion after SCI enhances recovery of upright sitting from destabilizing events.
Kiley L Armstrong, Lisa M Lombardo, Kevin M Foglyano...
https://pubmed.ncbi.nlm.nih.gov/29530053Long-Term Performance and User Satisfaction With Implanted Neuroprostheses for Upright Mobility After Paraplegia: 2- to 14-Year Follow-Up.
Ronald J Triolo, Stephanie Nogan Bailey, Kevin M Foglyano...
https://pubmed.ncbi.nlm.nih.gov/28899825The effects of combined trunk and gluteal neuromuscular electrical stimulation on posture and tissue health in spinal cord injury.
Gary A Wu, Lisa Lombardo, Ronald J Triolo...
https://pubmed.ncbi.nlm.nih.gov/23542776Effects of stimulating hip and trunk muscles on seated stability, posture, and reach after spinal cord injury.
Ronald J Triolo, Stephanie Nogan Bailey, Michael E Miller...
https://pubmed.ncbi.nlm.nih.gov/23500182