Spinal Cord Injuries
Conditions
Keywords
Functional Electrical Stimulation, Cycling, Virtual Reality
Brief summary
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
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.
Interventions
DEVICEFES
Functional Electrical Stimulation during cycling with Virtual Reality Feedback
Sponsors
University College, London
University of Southampton
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Technology development and Observational study
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No
Inclusion criteria
1\. using a wheelchair for at least two hours per day
Exclusion criteria
1. cardiac pacemaker 2. pressure sores or unresolved skin problems 3. unhealed lower limb fractures 4. pregnancy 5. active heterotrophic ossification (lower limbs) 6. severe osteoporosis 7. complex regional pain syndrome 8. metal implants near electrode sites 9. lower limb malignancy 10. T6 and below spinal malignancy 11. uncontrolled autonomic dysreflexia 12. history of knee dislocation/subluxation 13. allergy to electrodes 14. cognitive difficulties 15. severe spasticity (Ashworth scale 4 or 5 in muscle groups that would prevent smooth pedalling) or 16. neurological degenerative diseases.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| International Standards for Neurological Classification of Spinal Cord Injury (ISNC-SCI). | Change between baseline and 4 weeks | Neurological Classification |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Oxford scale motor power grading | Change between baseline and 4 weeks | Muscle strength |
| Modified Ashworth Score (MAS) | Change between baseline and 4 weeks | Spasticity / stiffness |
| Spinal Cord Independence Measure (SCIM) | Change between baseline and 4 weeks | ADL |
| Walking Index for Spinal Cord Injury (WISCI II) | Change between baseline and 4 weeks | Walking ability |
Outcome results
None listed