A Novel Combined Neuromodulation Therapy to Enhance Balance and Neuroplasticity
Spinal Cord Injuries, Muscle Pareses, Fall
About this trial
This is an interventional treatment trial for Spinal Cord Injuries
Eligibility Criteria
Inclusion Criteria: A traumatic or non-traumatic, non-progressive motor iSCI [American Spinal Injury Association Impairment Scale (AIS) rating of C or D]; More than 1-year post-injury; ≥18 years old; BBS score <46; Free of any other condition besides SCI that significantly affects walking or balance (e.g., no vestibular disorder, significant vision loss, stroke) Exclusion Criteria: Neurological lesion levels below T12 ; Severe spasticity in the legs; Contractures in the lower extremities that prevent achieving a neutral hip and ankle position, or extended knee; Peripheral nerve damage in the legs (i.e. leg muscles unresponsive to electrical stimulation); A pressure sore (>grade 2) on the pelvis or trunk where the safety harness is applied; Pregnancy; History of epilepsy; Contraindications for electrical stimulation (i.e. implanted electronic device, active cancer or radiation in past months, epilepsy, skin rash/wound at a potential electrode site)
Sites / Locations
- Toronto Rehabilitation Institute-Lyndhurst Center
Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
FES+TSCS (combined) neuromodulation group
FES group
For the combined neuromodulation with VFT group, the sub-motor threshold, open-loop TSCS will be coupled with closed-loop FES of ankle muscles during VFT. For this purpose, 2 electrical stimulators, one for each leg will stimulate SOL and TA muscles bilaterally while open-loop tonic lumbar TSCS will be applied at an intensity producing paresthesia in most of the lower-limb dermatomes
For the FES with VFT group, participants will receive visual feedback regarding their center of pressure location during four games with varying levels of difficulty and FES will be applied bilaterally to SOL and TA via a closed-loop system.