Functional Electrical Stimulation Cycling in SCI

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Brief Title

Functional Electrical Stimulation Cycling in SCI

Official Title

Functional Electrical Stimulation Cycling in Acute Spinal Cord Injury; a Feasibility Study

Brief Summary

      Spinal cord injury (SCI) is a devastating, life-altering injury; requiring tremendous changes
      in an individual's lifestyle. Cycling, provides an ideal way for individuals with SCI to
      exercise and address the long-term consequences of SCI by targeting the lower extremity
      muscles. Cycling with the addition of functional electrical stimulation (FES) allows persons
      with paralysis to exercise their paretic or paralysed leg muscles. The Queen Elizabeth
      National Spinal Injury Unit (QENSIU) in Glasgow offers FES cycling for people with spinal
      cord injuries, which combines functional electrical stimulation (FES) with a motorised
      ergometer that allows repetitive cycling activity. It stimulates muscles with electrodes
      attached to the skin, producing muscle contractions and patterned activity. So far no
      previous randomised control trials on FES cycling in the acute SCI population have reported
      changes in ability to undertake activities of daily living or the trunk balance.
    

Detailed Description

      Up to 12 participants admitted to the QENSIU will be recruited to the study. They will be
      randomised to the intervention (n=8) or control group (n=4). The intervention group will
      receive 6 weeks FES cycling training in addition to usual care; the control group will
      receive usual care only. Outcome measures: Spinal Cord Injury Functional Ambulation
      Inventory, The Spinal Cord Independence Measure, ASIA Impairment Scale, Handheld dynamometry,
      10-Metre Walking Test, Timed Up and Go Test, Trunk Impairment Scale, Modified Ashworth scale,
      Modified Tardieu Scale, the Patients Global Impression of Change.
    


Study Type

Interventional


Primary Outcome

Change in Spinal Cord Injury Functional Ambulation Inventory (SCI- FAI)

Secondary Outcome

 The Spinal Cord Independence Measure (SCIM III)

Condition

Spinal Cord Injury, Acute

Intervention

FES Cycling

Study Arms / Comparison Groups

 Intervention
Description:  FES cycle training will be performed on the RT300 FES cycle ideally 3 times per week for 6 weeks, each session lasting up to 90 minutes. Electrical stimulation will be delivered through up to 12 independent channels each delivering up to 140 mA current on the following muscles (both on the right and left leg): quadriceps, femoral biceps and gluteus, gastrocnemius and tibialis anterior. Abdominal and back extensor muscles may also be stimulated if the participant presents with neurological trunk weakness (SCI above T6). The FES unit will stimulate the muscles that extend the hip (gluteals), flex the knee (hamstrings) and extend the knee (quadriceps) in the correct order to bring about a cycling motion. The feet and lower legs of the participants will be strapped into the pedals and the wheelchair will be coupled in a rigid manner with the training device.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Device

Estimated Enrollment

12

Start Date

June 1, 2019

Completion Date

July 2020

Primary Completion Date

July 2020

Eligibility Criteria

        Inclusion Criteria:

          -  identified as being medically stable by the treating consultant,

          -  within the first 6 weeks post-injury,

          -  able to sit for 2 hours in a wheelchair,

          -  over 18 years old,

          -  acquired non progressive SCI - traumatic, spinal cord stroke, surgical injury,

          -  an incomplete SCI, graded as American Spinal Injury Association (ASIA) B (motor
             complete, sensation present below the lesion); C (some but not useful motor function)
             or D (useful motor function present),

        Exclusion Criteria:

          -  acute condition impairing participant's ability to cycle (eg, leg fracture),

          -  proven or suspected neuromuscular weakness affecting the legs due to another condition
             (eg, stroke or Guillain-Barré syndrome),

          -  unable to follow instruction in English

          -  symptomatic cardiac disease,

          -  ventilator dependency,

          -  severe spasticity,

          -  uncontrolled autonomic dysreflexia,

          -  possible, suspected or confirmed pregnancy,

          -  likely to be discharged before the end of the exercise intervention.

          -  unable to tolerate the sensation of FES
      

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Aleksandra Dybus, PhD, 01412327888, [email protected]

Location Countries

United Kingdom

Location Countries

United Kingdom

Administrative Informations


NCT ID

NCT04064385

Organization ID

GN19NE123


Responsible Party

Principal Investigator

Study Sponsor

Glasgow Caledonian University

Collaborators

 NHS Greater Glasgow and Clyde

Study Sponsor

Aleksandra Dybus, PhD, Principal Investigator, Glasgow Caledonian University


Verification Date

August 2019