A Neuroprosthesis for Seated Posture and Balance
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age21+
SponsorVA Office of Research and Development
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
C4-T12
ASIA Scale A through C
Time post injury greater than 6 months
Innervated and excitable trunk and pelvis musculature
Disqualifiers
Pregnancy
Non-English speaking
Trial design
Design model
Single group
Treatments tested in this trial
IRS-8 (8-Channel implanted stimulator-telemeter)
DeviceSurgical implantation of the 8-channel neuroprosthesis
Treatment groups
10 Participants
are divided into 1 treatment groupGroup A: NeuroprosthesisExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Effect of Trunk stimulation on control seated posture, respiration, seated interface pressures, reach ability, seated stability & personal mobility.
Experiments involving the effects of trunk stimulation on postural alignment; trunk stability and posture on respiration, postural variation on seated interface pressures; effects of trunk stimulation on reaching ability; effects of trunk stimulation on seated stability, and personal mobility.
Time frame
up to 36 monthsSecondary outcomes
1
Design a simple position controller
The position controller will be developed to keep the trunk posture at a neutral seated position while allowing movement to lean forward, backward, or side-to-side. Testing will be carried out with an automated pull system applied to the trunk which pulls the body in various ways (side-to-side, forward, backward)
Time frame
Up to 36 monthsSponsors and contacts
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Source ClinicalTrials.gov