Functional Electrical Stimulation During Cycling in People With Spinal Cord Injury

NCT ID: NCT03834324

Last Updated: 2021-10-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 11 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-05-03
• Study Completion Date: 2018-03-01

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.

Conditions

Spinal Cord Injuries

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

intervention

FES

Group Type: EXPERIMENTAL

FES

Intervention Type: DEVICE

Functional Electrical Stimulation during cycling with Virtual Reality Feedback

Interventions

FES

Functional Electrical Stimulation during cycling with Virtual Reality Feedback

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University College, London

OTHER

Sponsor Role: collaborator

University of Southampton

OTHER

Sponsor Role: lead

Responsible Party

Jane Burridge, PhD

Professor of Restorative Neuroscience

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Trudi Bartlett, BSc

Role: STUDY_CHAIR

University of Southampton

References

Duffell LD, Paddison S, Alahmary AF, Donaldson N, Burridge J. The effects of FES cycling combined with virtual reality racing biofeedback on voluntary function after incomplete SCI: a pilot study. J Neuroeng Rehabil. 2019 Nov 27;16(1):149. doi: 10.1186/s12984-019-0619-4.

Reference Type: RESULT

PMID: 31771600 (View on PubMed)

Other Identifiers

6054

Identifier Type: -

Identifier Source: org_study_id