Functional Electrical Stimulation During Cycling in People With Spinal Cord Injury (iCycle)

University of Southampton

Status: Completed

Conditions: Spinal Cord Injuries

Treatments: Device: FES

Study type: Interventional

Funder types: Other

Identifiers

NCT03834324

6054

Details and patient eligibility

About

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.

Full 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.

Enrollment: 11 patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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11 participants in 1 patient group

intervention

Experimental group

Description:

FES

Treatment:

Device: FES