Functional Electrical Stimulation During Cycling in People With Spinal Cord Injury

Spinal Cord Injuries Clinical Trial

— iCycle  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03834324
• Other study ID #: 6054
• Status: Completed
• Phase: N/A
• Start date: May 3, 2013
• Est. completion date: March 1, 2018

Study information

• Verified date: February 2019
• Source: University of Southampton
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 11
• Est. completion date: March 1, 2018
• Est. primary completion date: April 29, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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.

Related Conditions & MeSH terms

• Spinal Cord Injuries

Intervention

Device:
• FES
Functional Electrical Stimulation during cycling with Virtual Reality Feedback

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
University of Southampton	University College, London

References & Publications (1)

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/s1 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	International Standards for Neurological Classification of Spinal Cord Injury (ISNC-SCI).	Neurological Classification	Change between baseline and 4 weeks
Primary	International Standards for Neurological Classification of Spinal Cord Injury (ISNC-SCI).	Neurological Classification	Change between baseline and 8 weeks
Secondary	Oxford scale motor power grading	Muscle strength	Change between baseline and 4 weeks
Secondary	Oxford scale motor power grading	Muscle strength	Change between baseline and 8 weeks
Secondary	Modified Ashworth Score (MAS)	Spasticity / stiffness	Change between baseline and 4 weeks
Secondary	Modified Ashworth Score (MAS)	Spasticity / stiffness	Change between baseline and 8 weeks
Secondary	Spinal Cord Independence Measure (SCIM)	ADL	Change between baseline and 4 weeks
Secondary	Spinal Cord Independence Measure (SCIM)	ADL	Change between baseline and 8 weeks
Secondary	Walking Index for Spinal Cord Injury (WISCI II)	Walking ability	Change between baseline and 4 weeks
Secondary	Walking Index for Spinal Cord Injury (WISCI II)	Walking ability	Change between baseline and 8 weeks