Upper Extremity Functional Electrical Stimulation (FES) for Restoration of Upper Extremity Functi… (NCT06672458) | Clinical Trial Compass
RecruitingNot Applicable
Upper Extremity Functional Electrical Stimulation (FES) for Restoration of Upper Extremity Function After Spinal Cord Injury (SCI)
United States60 participantsStarted 2024-11-01
Plain-language summary
The purpose of this research is to examine the effects that functional electrical stimulation (FES) therapy has on the way the arms, brain and spinal cord work. The study team wants to understand what recovery looks like in persons with a spinal cord injury (SCI) or peripheral nerve injury (PNI) using the MyndMove (MyndTec Inc., Ontario, Canada) therapy system. This type of therapy uses stimulation to help people with SCI and other neurological conditions to perform common tasks, work out, or strengthen muscles.
Who can participate
Age range18 Years – 70 Years
SexALL
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Inclusion criteria
✓. Traumatic spinal cord injury (SCI): neurological level at or above T1 spinal cord level; AIS A, B, C or D impairment grade
✓. Peripheral nerve injury (PNI), with or without SCI, who are pre- or post- upper extremity (UE) nerve transfer surgery
Exclusion criteria
✕. Traumatic brain injury, stroke, multiple sclerosis, or other disorders that could affect neuromotor function.
✕. Severe spasticity that could prevent the study protocol as determined by the investigator.
✕. Major executive dysfunction, dementia, depression, neurocognitive impairments, or other major medical co-morbidities.
✕. Has contraindications for transcutaneous stimulation using FES such as breakdown of skin in the area that will come into contact with electrodes, thrombosis, or skin disease
✕. Poorly managed autonomic dysreflexia that could be triggered by FES.
✕. Unhealed upper extremity fracture, contracture, or pressure sore.
What they're measuring
1
Nine Hole Peg Test
Timeframe: baseline and up to 2 weeks
2
Surface EMG
Timeframe: baseline and up to 2 weeks
3
Graded-Redefined Assessment of Strength, Sensibility, and Prehension (GRASSP) Prehension Performance (GR-PP)