Augmenting Reactive Stepping With FES After SCI

Study Overview
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Brief Summary
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Up to 25 individuals living with chronic incomplete spinal cord injury (iSCI) who can stand but have limited ability to elicit a step without physical assistance or upper limb (U/L) support will be recruited for this study. The first objective of the study will aim to investigate the orthotic effect (i.e., immediate effect) of FES on the reactive stepping response. The second objective is to investigate the therapeutic effect of a novel balance intervention, perturbation-based balance training (PBT) combined with FES (i.e., PBT+FES) on reactive stepping ability, measures of postural sway during quiet standing (i.e., biomechanical measures), and scores on clinical measures of balance and walking.

Official Title
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Augmenting Reactive Stepping With Functional Electrical Stimulation for Individuals Living With Incomplete Spinal Cord Injury

Conditions
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Spinal Cord Injuries

Intervention / Treatment
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* Behavioral: Perturbation-based balance training with functional electrical stimulation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: have a motor incomplete SCI (i.e., AIS grade C or D) that is non-progressive; be at least one year post-injury (i.e., chronic injury); ≥ 18 years old; be able to stand independently for 60 sec; unable to take a step bilaterally without physical assistance or upper extremity support; able to understand spoken English; free of any other condition besides SCI that significantly affects walking or balance (e.g., no vestibular disorder, significant vision loss, stroke); be able to provide informed, written consent. Exclusion Criteria: Contraindications for EMS. Electrical stimulation will not be used if: it will be applied to areas where it could cause malfunction of electronic devices, including cardiac pacemakers; a woman is pregnant; the applied region has known or suspected malignancy; the person has active deep vein thrombosis or thrombophlebitis; there are active bleeding tissues, or the person has untreated hemorrhagic disorders; there are infected tissues, tuberculosis, or wounds with underlying osteomyelitis; tissues have been radiated in the past six months; there are damaged skin areas or at-risk skin areas that would result in uneven conduction of current; severe spasticity is present in the legs; the person has contractures in the lower limbs that prevent achieving a neutral hip and ankle position, or extended knee; there is a history of prior lower limbs fragility fracture; the leg muscles are unresponsive to electrical stimulation (i.e., peripheral nerve damage in the legs). Pressure sores on pelvis or trunk, where safety harness will be donned.

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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Perturbation-based balance training with FES<br> | Behavioral: Perturbation-based balance training with functional electrical stimulation<br>* The PBT program will consist of repetitive practice of reactive stepping for one hour. The participants will be equipped with the Odstock 2-Channel stimulator on one or both sides depending on their deficits. One channel of stimulation may be applied to the common fibular nerve to elicit a flexor withdraw reflex and elicit a step. The second channel of stimulation may be applied to the quadriceps muscles to assist with the supporting phase of the reactive step, as required. Participants will experience about 60 perturbations per session during balance exercises. To create a perturbation, the researcher will apply unexpected pushes or pulls to a safety harness around the participant's trunk. Throughout the hour-long session, participants will complete challenging balance tasks, customized to their ability level, during standing and walking. The training will be supervised by a licensed physiotherapist and administered by a licensed physiotherapist or registered kinesiologist.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Lean-and-release test | Test of reactive stepping and balance in the forward direction | Up to 7 weeks | 
| Biomechanical measures of postural control | Measurement of centre of pressure during quiet standing | Up to 7 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mini-Balance Evaluation Systems Test | Assesses four balance control systems | Up to 7 weeks | 
| Activities-specific Balance Confidence Scale | Assesses balance efficacy | Up to 7 weeks | 
| Gait parameters | Step length (cm), gait speed (m/s), double support time (%) | Up to 7 weeks | 
| Falls Efficacy Scale International | Assesses the degree of concern about fear of falling | Up to 7 weeks | 
| Semi-structured interview | Queries the participants' perceived challenges and benefits of the PBT+FES program | 3 months post |