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Completed

NCT Number: NCT03834324

Functional Electrical Stimulation During Cycling in People With Spinal Cord Injury

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.

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Key information

Conditions

Spinal Cord Injuries Central Nervous System Diseases Nervous System Diseases Spinal Cord Diseases Trauma, Nervous System Wounds and Injuries

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Treatment and study plan

FES

Device

Functional Electrical Stimulation during cycling with Virtual Reality Feedback

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

University of Southampton

Other

Collaborators

  • University College, London

Registry information

Official study title

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

Acronym: iCycle

Important dates

Study start
2013
Primary completion
2016
Study completion
2018
First posted
Feb 7, 2019
Registry last updated
Oct 8, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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