- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03834324
Functional Electrical Stimulation During Cycling in People With Spinal Cord Injury (iCycle)
The Effects of FES Cycling Combined With Virtual Reality Racing on Lower Limb Voluntary Function After Incomplete SCI: A Pilot Study.
Study Overview
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: intervention
FES
|
Functional Electrical Stimulation during cycling with Virtual Reality Feedback
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
International Standards for Neurological Classification of Spinal Cord Injury (ISNC-SCI).
Time Frame: Change between baseline and 4 weeks
|
Neurological Classification
|
Change between baseline and 4 weeks
|
International Standards for Neurological Classification of Spinal Cord Injury (ISNC-SCI).
Time Frame: Change between baseline and 8 weeks
|
Neurological Classification
|
Change between baseline and 8 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Oxford scale motor power grading
Time Frame: Change between baseline and 4 weeks
|
Muscle strength
|
Change between baseline and 4 weeks
|
Oxford scale motor power grading
Time Frame: Change between baseline and 8 weeks
|
Muscle strength
|
Change between baseline and 8 weeks
|
Modified Ashworth Score (MAS)
Time Frame: Change between baseline and 4 weeks
|
Spasticity / stiffness
|
Change between baseline and 4 weeks
|
Modified Ashworth Score (MAS)
Time Frame: Change between baseline and 8 weeks
|
Spasticity / stiffness
|
Change between baseline and 8 weeks
|
Spinal Cord Independence Measure (SCIM)
Time Frame: Change between baseline and 4 weeks
|
ADL
|
Change between baseline and 4 weeks
|
Spinal Cord Independence Measure (SCIM)
Time Frame: Change between baseline and 8 weeks
|
ADL
|
Change between baseline and 8 weeks
|
Walking Index for Spinal Cord Injury (WISCI II)
Time Frame: Change between baseline and 4 weeks
|
Walking ability
|
Change between baseline and 4 weeks
|
Walking Index for Spinal Cord Injury (WISCI II)
Time Frame: Change between baseline and 8 weeks
|
Walking ability
|
Change between baseline and 8 weeks
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Study Chair: Trudi Bartlett, BSc, University of Southampton
Publications and helpful links
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 6054
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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