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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03834324
Recruitment Status : Completed
First Posted : February 7, 2019
Last Update Posted : February 7, 2019
Sponsor:
Collaborator:
University College, London
Information provided by (Responsible Party):
Jane Burridge, PhD, University of Southampton

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.

Condition or disease Intervention/treatment Phase
Spinal Cord Injuries Device: FES Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 11 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: Technology development and Observational study
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Effects of FES Cycling Combined With Virtual Reality Racing on Lower Limb Voluntary Function After Incomplete SCI: A Pilot Study.
Actual Study Start Date : May 3, 2013
Actual Primary Completion Date : April 29, 2016
Actual Study Completion Date : March 1, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: intervention
FES
Device: FES
Functional Electrical Stimulation during cycling with Virtual Reality Feedback




Primary Outcome Measures :
  1. International Standards for Neurological Classification of Spinal Cord Injury (ISNC-SCI). [ Time Frame: Change between baseline and 4 weeks ]
    Neurological Classification

  2. International Standards for Neurological Classification of Spinal Cord Injury (ISNC-SCI). [ Time Frame: Change between baseline and 8 weeks ]
    Neurological Classification


Secondary Outcome Measures :
  1. Oxford scale motor power grading [ Time Frame: Change between baseline and 4 weeks ]
    Muscle strength

  2. Oxford scale motor power grading [ Time Frame: Change between baseline and 8 weeks ]
    Muscle strength

  3. Modified Ashworth Score (MAS) [ Time Frame: Change between baseline and 4 weeks ]
    Spasticity / stiffness

  4. Modified Ashworth Score (MAS) [ Time Frame: Change between baseline and 8 weeks ]
    Spasticity / stiffness

  5. Spinal Cord Independence Measure (SCIM) [ Time Frame: Change between baseline and 4 weeks ]
    ADL

  6. Spinal Cord Independence Measure (SCIM) [ Time Frame: Change between baseline and 8 weeks ]
    ADL

  7. Walking Index for Spinal Cord Injury (WISCI II) [ Time Frame: Change between baseline and 4 weeks ]
    Walking ability

  8. Walking Index for Spinal Cord Injury (WISCI II) [ Time Frame: Change between baseline and 8 weeks ]
    Walking ability



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03834324


Sponsors and Collaborators
University of Southampton
University College, London
Investigators
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Study Chair: Trudi Bartlett, BSc University of Southampton
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Jane Burridge, PhD, Professor of Restorative Neuroscience, University of Southampton
ClinicalTrials.gov Identifier: NCT03834324    
Other Study ID Numbers: 6054
First Posted: February 7, 2019    Key Record Dates
Last Update Posted: February 7, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: we have no specific plan for this

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Jane Burridge, PhD, University of Southampton:
Functional Electrical Stimulation
Cycling
Virtual Reality
Additional relevant MeSH terms:
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Spinal Cord Injuries
Wounds and Injuries
Spinal Cord Diseases
Central Nervous System Diseases
Nervous System Diseases
Trauma, Nervous System