Restoring Upright Mobility After Spinal Cord Injury

Study Overview
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Brief Summary
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Up to 15 able-bodied individuals will participate in one testing session to evaluate the effectiveness of the A-FES system. Up to 20 individuals with SCI will participate in 12 sessions of A-FES therapy. At each session, participants will stand on a force plate (Accu Sway, AMTI, USA) with the A-FES system (Compex Motion II, Compex Motion, Switzerland) donned. The centre of pressure (COP) will be calculated in real time using the force plate data. The calculated COP will be presented to participants on a monitor and they will be instructed to shift their COP in the indicated directions as represented by a cursor (i.e. training with visual feedback). The intensity of electrical stimulation provided by the A-FES system will be regulated by the measured COP in a closed-loop manner. In this study we propose to develop and evaluate the clinically-feasible A-FES system for the training of standing balance.

Official Title
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Restoring Upright Mobility After Spinal Cord Injury Using Functional Electrical Stimulation

Conditions
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Spinal Cord Injuries, Spinal Cord Diseases

Intervention / Treatment
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* Device: Functional Electrical Stimulation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: A traumatic or non-traumatic, non-progressive (AIS) C or D SCI; ≥18 years old; Able to stand independently for 60s; Moderate level of trunk control as evidenced by the ability to reach forward >2 inches in standing (i.e. score of 2 on the BBS Reaching Forward task50,51); and Free of any other condition besides SCI that significantly affects walking or balance (e.g., no vestibular disorder, significant vision loss, stroke). Exclusion Criteria: Severe spasticity in the legs; Contractures in the lower extremities that prevent achieving a neutral hip and ankle position, or extended knee; A prior lower extremity fragility fracture; An injection of botulinum toxin to leg muscles in the past six months; 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; o Contraindications for FES52 (i.e. implanted electronic device, active cancer or radiation in past 6 months, epilepsy, skin rash/wound at a potential electrode site). Participants will be withdrawn from the study if FES irritates their skin.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Functional Electrical Stimulation|The device used was a prototype closed-loop FES system to improve standing balance by activating the ankle plantar flexors and dorsiflexors (i.e. A-FES system). As a closed-loop system, the body's position and velocity are continually monitored, and the level of stimulation adjusted accordingly on a moment-to-moment basis. This differs from currently available FES units, which do not monitor body movement and therefore, provide a constant level of stimulation unless manually adjusted by the user/PT. The control strategy used in the A-FES system mimics the physiological control system in able-bodied people, meaning it has the potential to re-educate normal movement patterns.|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Berg Balance Scale | Assesses static and dynamic standing balance; score 0-56; higher score means a better outcome | Change from Baseline Berg Balance Scale at 8 weeks | 
| Mini-Balance Evaluation Systems Test | Assesses four balance control systems, including anticipatory balance, reactive postural control, sensory orientation and dynamic gait | Change from Baseline Mini-Balance Evaluation Systems Test at 8 weeks | 
| Activities-specific Balance Confidence Scale | A measure of balance self-efficacy; mean score of 0-100; higher score means a better outcome (i.e. high balance confidence) | Change from Baseline Activities-specific Balance Confidence Scale at 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Static standing balance | Postural sway during quiet standing | Through study completion, average of 8 weeks | 
| Dynamic standing balance | Assessed by asking participants to lean as far as possible in the forward, backward and sideways directions while standing on a force plate (i.e. limits of stability test) | Through study completion, average of 8 weeks | 
| Semi-structured interview | The guide will include open-ended questions concerning the participant's experience with, and impressions of, A-FES therapy | up to 8 weeks post-intervention | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Functional Electrical Stimulation, Balance