A Neuroprosthesis for Seated Posture and Balance
| Status: | Recruiting |
|---|---|
| Conditions: | Hospital, Neurology, Orthopedic |
| Therapuetic Areas: | Neurology, Orthopedics / Podiatry, Other |
| Healthy: | No |
| Age Range: | 21 - Any |
| Updated: | 2/20/2019 |
| Start Date: | July 1, 2011 |
| End Date: | January 31, 2020 |
| Contact: | Lisa M Lombardo, MPT |
| Email: | Lisa.Lombardo2@va.gov |
| Phone: | (216) 791-3800 |
The purpose of this study is to evaluate a surgically implanted functional electrical
stimulation (FES) system to facilitate stability of the trunk and hips. FES involves applying
small electric currents to the nerves, which cause the muscles to contract. This study
evaluates how stabilizing and stiffening the trunk with FES can change the way spinal cord
injured volunteers sit, breathe, reach, push a wheelchair, or roll in bed.
stimulation (FES) system to facilitate stability of the trunk and hips. FES involves applying
small electric currents to the nerves, which cause the muscles to contract. This study
evaluates how stabilizing and stiffening the trunk with FES can change the way spinal cord
injured volunteers sit, breathe, reach, push a wheelchair, or roll in bed.
In a single surgical procedure electrodes will be inserted into muscles of the trunk and hip
musculature. The electrode leads are connected to a stimulator/telemeter located in the
abdomen. After a typical post-operative period of two to five days, neuroprosthesis
recipients will be discharged to home for two to six weeks of restricted activity to promote
healing of all surgical incisions. After a period of exercise and training, functional use of
the neuroprosthesis will begin. Laboratory assessments of strength, balance, and functional
abilities with and without the system, as well as the technical performance of the implanted
components will be evaluated.
musculature. The electrode leads are connected to a stimulator/telemeter located in the
abdomen. After a typical post-operative period of two to five days, neuroprosthesis
recipients will be discharged to home for two to six weeks of restricted activity to promote
healing of all surgical incisions. After a period of exercise and training, functional use of
the neuroprosthesis will begin. Laboratory assessments of strength, balance, and functional
abilities with and without the system, as well as the technical performance of the implanted
components will be evaluated.
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
We found this trial at
1
site
Cleveland, Ohio 44106
Principal Investigator: Ronald Triolo, PhD
Phone: 216-791-3800
Click here to add this to my saved trials
