Functional Electrical Stimulation During Cycling in People With Spinal Cord Injury

Study Overview
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Brief Summary
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Neuroscience research that has identified potential for recovery (neuroplasticity) following incomplete SCI has changed clinical practice away from compensation strategies towards optimizing recovery. Important factors include: repetitive exercise, Functional Electrical Stimulation (FES) and appropriate feedback. The iCycle combines repetitive exercise with FES and provides feedback on performance in a virtual cycle race. Unlike previous devices, performance in the race is determined only by voluntary effort (i.e. not torque generated by FES plus voluntary effort). In this study with incomplete SCI participants we will test the iCycle with six inpatients to refine the protocol and make technical improvements. We will then conduct an ABA pilot study (n=10) in which a 3G-connected iCycle is used in people's own homes. We will compare usual care (A) with iCycle exercise (B). Changes in neural connectivity (TMS evoked EMG potentials), muscle strength and walking will be measured as well qualitative analysis of users' views.

Detailed Description
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Background: Functional Electrical Stimulation (FES) cycling can benefit health and may lead to neuroplastic changes following incomplete spinal cord injury (SCI). Our hypothesis is that greater neuroplastic effects occur when electrical stimulation of peripheral nerves is combined with voluntary drive. In this pilot study, we will investigate the effects of a one-month training programme using a novel device, the iCycle, in which voluntary effort (cortical drive) is encouraged by virtual reality biofeedback during FES cycling. Methods: Eleven participants (C1-T12) with incomplete SCI (5 sub-acute; 6 chronic) will be recruited and undergo 12-sessions of iCycle training. Function will be assessed before and after training using the bilateral ISNC-SCI motor score neurological (motor) function, Oxford power grading, Modified Ashworth Score, Spinal Cord Independence Measure, the Walking Index for Spinal Cord Injury and 10m-walk test. Power output will be measured during training.

Official Title
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The Effects of FES Cycling Combined With Virtual Reality Racing on Lower Limb Voluntary Function After Incomplete SCI: A Pilot Study.

Conditions
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Spinal Cord Injuries

Intervention / Treatment
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* Device: FES


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 1. using a wheelchair for at least two hours per day Exclusion Criteria: cardiac pacemaker pressure sores or unresolved skin problems unhealed lower limb fractures pregnancy active heterotrophic ossification (lower limbs) severe osteoporosis complex regional pain syndrome metal implants near electrode sites lower limb malignancy T6 and below spinal malignancy uncontrolled autonomic dysreflexia history of knee dislocation/subluxation allergy to electrodes cognitive difficulties severe spasticity (Ashworth scale 4 or 5 in muscle groups that would prevent smooth pedalling) or neurological degenerative diseases.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 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
Interventional Model Description: Technology development and Observational study
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: intervention<br>FES | Device: FES<br>* Functional Electrical Stimulation during cycling with Virtual Reality Feedback<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| International Standards for Neurological Classification of Spinal Cord Injury (ISNC-SCI). | Neurological Classification | Change between baseline and 4 weeks | 
| International Standards for Neurological Classification of Spinal Cord Injury (ISNC-SCI). | Neurological Classification | Change between baseline and 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Oxford scale motor power grading | Muscle strength | Change between baseline and 4 weeks | 
| Oxford scale motor power grading | Muscle strength | Change between baseline and 8 weeks | 
| Modified Ashworth Score (MAS) | Spasticity / stiffness | Change between baseline and 4 weeks | 
| Modified Ashworth Score (MAS) | Spasticity / stiffness | Change between baseline and 8 weeks | 
| Spinal Cord Independence Measure (SCIM) | ADL | Change between baseline and 4 weeks | 
| Spinal Cord Independence Measure (SCIM) | ADL | Change between baseline and 8 weeks | 
| Walking Index for Spinal Cord Injury (WISCI II) | Walking ability | Change between baseline and 4 weeks | 
| Walking Index for Spinal Cord Injury (WISCI II) | Walking ability | Change between baseline and 8 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Functional Electrical Stimulation, Cycling, Virtual Reality