A Neuroprosthesis for Seated Posture and Balance
Trunk Protocol
2 other identifiers
interventional
10
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Nov 2011
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 8, 2011
CompletedFirst Posted
Study publicly available on registry
November 18, 2011
CompletedStudy Start
First participant enrolled
November 30, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 31, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
January 31, 2027
October 27, 2025
October 1, 2025
15.2 years
November 8, 2011
October 23, 2025
Conditions
Keywords
Outcome Measures
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.
up to 36 months
Secondary Outcomes (1)
Design a simple position controller
Up to 36 months
Study Arms (1)
Neuroprosthesis
EXPERIMENTALVolunteers are evaluated for appropriateness for inclusion in the study on an intent-to-treat basis. Qualifying candidates all receive the implanted neuroprosthesis and participate in post-operative training and follow-up procedures.
Interventions
Surgical implantation of the 8-channel neuroprosthesis
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Pregnancy
- Non-English speaking
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Louis Stokes VA Medical Center, Cleveland, OH
Cleveland, Ohio, 44106-1702, United States
Related Publications (7)
Triolo RJ, Boggs L, Miller ME, Nemunaitis G, Nagy J, Bailey SN. Implanted electrical stimulation of the trunk for seated postural stability and function after cervical spinal cord injury: a single case study. Arch Phys Med Rehabil. 2009 Feb;90(2):340-7. doi: 10.1016/j.apmr.2008.07.029.
PMID: 19236990BACKGROUNDBogie KM, Triolo RJ. Effects of regular use of neuromuscular electrical stimulation on tissue health. J Rehabil Res Dev. 2003 Nov-Dec;40(6):469-75. doi: 10.1682/jrrd.2003.11.0469.
PMID: 15077659BACKGROUNDFoglyano KM, Lombardo LM, Schnellenberger JR, Triolo RJ. Sudden stop detection and automatic seating support with neural stimulation during manual wheelchair propulsion. J Spinal Cord Med. 2022 Mar;45(2):204-213. doi: 10.1080/10790268.2020.1800278. Epub 2020 Aug 14.
PMID: 32795162DERIVEDArmstrong KL, Lombardo LM, Foglyano KM, Audu ML, Triolo RJ. Automatic application of neural stimulation during wheelchair propulsion after SCI enhances recovery of upright sitting from destabilizing events. J Neuroeng Rehabil. 2018 Mar 12;15(1):17. doi: 10.1186/s12984-018-0362-2.
PMID: 29530053DERIVEDTriolo RJ, Bailey SN, Foglyano KM, Kobetic R, Lombardo LM, Miller ME, Pinault G. Long-Term Performance and User Satisfaction With Implanted Neuroprostheses for Upright Mobility After Paraplegia: 2- to 14-Year Follow-Up. Arch Phys Med Rehabil. 2018 Feb;99(2):289-298. doi: 10.1016/j.apmr.2017.08.470. Epub 2017 Sep 9.
PMID: 28899825DERIVEDWu GA, Lombardo L, Triolo RJ, Bogie KM. The effects of combined trunk and gluteal neuromuscular electrical stimulation on posture and tissue health in spinal cord injury. PM R. 2013 Aug;5(8):688-96. doi: 10.1016/j.pmrj.2013.03.025. Epub 2013 Mar 28.
PMID: 23542776DERIVEDTriolo RJ, Bailey SN, Miller ME, Lombardo LM, Audu ML. Effects of stimulating hip and trunk muscles on seated stability, posture, and reach after spinal cord injury. Arch Phys Med Rehabil. 2013 Sep;94(9):1766-75. doi: 10.1016/j.apmr.2013.02.023. Epub 2013 Mar 13.
PMID: 23500182DERIVED
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Ronald Triolo, PhD
Louis Stokes VA Medical Center, Cleveland, OH
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- FED
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 8, 2011
First Posted
November 18, 2011
Study Start
November 30, 2011
Primary Completion (Estimated)
January 31, 2027
Study Completion (Estimated)
January 31, 2027
Last Updated
October 27, 2025
Record last verified: 2025-10
Data Sharing
- IPD Sharing
- Will not share