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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
University of Southampton
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Spinal Cord Injuries focused on measuring Functional Electrical Stimulation, Cycling, Virtual Reality

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

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

    First Posted
    February 5, 2019
    Last Updated
    October 1, 2021
    Sponsor
    University of Southampton
    Collaborators
    University College, London
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    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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