Functional Electrical Stimulation During Cycling in People With Spinal Cord Injury (iCycle)
Primary Purpose
Spinal Cord Injuries
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
FES
Sponsored by
About this trial
This is an interventional treatment trial for Spinal Cord Injuries focused on measuring Functional Electrical Stimulation, Cycling, Virtual Reality
Eligibility Criteria
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.
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
intervention
Arm Description
FES
Outcomes
Primary Outcome Measures
International Standards for Neurological Classification of Spinal Cord Injury (ISNC-SCI).
Neurological Classification
International Standards for Neurological Classification of Spinal Cord Injury (ISNC-SCI).
Neurological Classification
Secondary Outcome Measures
Oxford scale motor power grading
Muscle strength
Oxford scale motor power grading
Muscle strength
Modified Ashworth Score (MAS)
Spasticity / stiffness
Modified Ashworth Score (MAS)
Spasticity / stiffness
Spinal Cord Independence Measure (SCIM)
ADL
Spinal Cord Independence Measure (SCIM)
ADL
Walking Index for Spinal Cord Injury (WISCI II)
Walking ability
Walking Index for Spinal Cord Injury (WISCI II)
Walking ability
Full Information
NCT ID
NCT03834324
First Posted
February 5, 2019
Last Updated
October 1, 2021
Sponsor
University of Southampton
Collaborators
University College, London
1. Study Identification
Unique Protocol Identification Number
NCT03834324
Brief Title
Functional Electrical Stimulation During Cycling in People With Spinal Cord Injury
Acronym
iCycle
Official Title
The Effects of FES Cycling Combined With Virtual Reality Racing on Lower Limb Voluntary Function After Incomplete SCI: A Pilot Study.
Study Type
Interventional
2. Study Status
Record Verification Date
February 2019
Overall Recruitment Status
Completed
Study Start Date
May 3, 2013 (Actual)
Primary Completion Date
April 29, 2016 (Actual)
Study Completion Date
March 1, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Southampton
Collaborators
University College, London
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Spinal Cord Injuries
Keywords
Functional Electrical Stimulation, Cycling, Virtual Reality
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Technology development and Observational study
Masking
None (Open Label)
Allocation
N/A
Enrollment
11 (Actual)
8. Arms, Groups, and Interventions
Arm Title
intervention
Arm Type
Experimental
Arm Description
FES
Intervention Type
Device
Intervention Name(s)
FES
Intervention Description
Functional Electrical Stimulation during cycling with Virtual Reality Feedback
Primary Outcome Measure Information:
Title
International Standards for Neurological Classification of Spinal Cord Injury (ISNC-SCI).
Description
Neurological Classification
Time Frame
Change between baseline and 4 weeks
Title
International Standards for Neurological Classification of Spinal Cord Injury (ISNC-SCI).
Description
Neurological Classification
Time Frame
Change between baseline and 8 weeks
Secondary Outcome Measure Information:
Title
Oxford scale motor power grading
Description
Muscle strength
Time Frame
Change between baseline and 4 weeks
Title
Oxford scale motor power grading
Description
Muscle strength
Time Frame
Change between baseline and 8 weeks
Title
Modified Ashworth Score (MAS)
Description
Spasticity / stiffness
Time Frame
Change between baseline and 4 weeks
Title
Modified Ashworth Score (MAS)
Description
Spasticity / stiffness
Time Frame
Change between baseline and 8 weeks
Title
Spinal Cord Independence Measure (SCIM)
Description
ADL
Time Frame
Change between baseline and 4 weeks
Title
Spinal Cord Independence Measure (SCIM)
Description
ADL
Time Frame
Change between baseline and 8 weeks
Title
Walking Index for Spinal Cord Injury (WISCI II)
Description
Walking ability
Time Frame
Change between baseline and 4 weeks
Title
Walking Index for Spinal Cord Injury (WISCI II)
Description
Walking ability
Time Frame
Change between baseline and 8 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Trudi Bartlett, BSc
Organizational Affiliation
University of Southampton
Official's Role
Study Chair
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
we have no specific plan for this
Citations:
PubMed Identifier
31771600
Citation
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.
Results Reference
result
Learn more about this trial
Functional Electrical Stimulation During Cycling in People With Spinal Cord Injury
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