Functional Electrical Stimulation Cycling in SCI

NCT04064385 | Unknown

• 1 other identifier: GN19NE123
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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.

Conditions

Spinal Cord Injury, Acute; Paraplegia; Tetraplegia

Keywords

Functional Electrical Stimulation Cycling; Physical Therapy

Outcome Measures

Primary Outcomes (1)

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

  It consists of three components: gait parameter, assistive device use and walking ability. The gait parameter component is scored out of 20, 10 points for each of the right and left sides. The assistive device component is scored out of 14 (7 points for each side), and assesses upper and lower extremities in addition to the left and right limbs. Scores within each component are summed. Component scores range from 0 to 20 in the gait parameter component, 0 to 14 in the assistive device component, and 0 to 5 in the walking mobility component. The SCI-FAI is a reliable, valid and sensitive measure of walking ability in individuals with spinal cord injury.

  baseline, 6 weeks, 12 weeks

Secondary Outcomes (9)

• The Spinal Cord Independence Measure (SCIM III)

  baseline, 6 weeks, 12 weeks

• ASIA Impairment Scale

  baseline, 6 weeks, 12 weeks

• Handheld dynamometry (HDD)

  baseline, 6 weeks, 12 weeks

• 10-Metre Walking Test (10MWT)

  baseline, 6 weeks, 12 weeks

• Timed Up and Go (TUG) Test

  baseline, 6 weeks, 12 weeks

Study Arms (2)

Intervention

EXPERIMENTAL

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.

Device: FES Cycling

Control

NO INTERVENTION

Participants in the control group will receive usual care, consistent with standard NHS care in this population. Usual physiotherapy care is provided, up to 2 times per day, 4 to 5 days per week, each lasting approximately 90 minutes. Physiotherapists provide one to one function-oriented physiotherapy session to improve balance, muscle strength and transfer skills.

Interventions

FES Cycling DEVICE

Stimulation parameters will be 450μs, 40Hz, and up to 140mA, these values will be changed if needed based on individual response. For example, stimulation to the gluteal muscles often may to be decreased to prevent autonomic dysreflexia. To receive correct stimulation parameters, stimulation intensity will be chosen to ensure a palpable muscle contraction and sensor tolerance. Each session will include a 2-minute warm-up and 2-minute cool-down of passive cycling. The unit automatically delivers enough stimulation to maintain a speed of 30 rotations per minute (rpm). Where this is not achieved, the leg cycle will assist the stimulated movement to maintain a speed of 30 rpm.

Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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),

You may not qualify if:

• 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

Sponsors & Collaborators

• Glasgow Caledonian University: lead
• NHS Greater Glasgow and Clyde: collaborator

Study Sites (1)

The Queen Elizabeth National Spinal Injuries Unit

Glasgow, G51 4TF, United Kingdom

RECRUITING

MeSH Terms

Conditions

Spinal Cord Injuries; Paraplegia; Quadriplegia

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries; Paralysis; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Aleksandra Dybus, PhD

  Glasgow Caledonian University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Aleksandra Dybus, PhD

CONTACT

01412327888; aleksandra.dybus@gcu.ac.uk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: REsearch Physiotherapist

Study Record Dates

• First Submitted: July 4, 2019
• First Posted: August 21, 2019
• Study Start: June 1, 2019
• Primary Completion: July 1, 2020
• Study Completion: July 1, 2020
• Last Updated: August 21, 2019

Record last verified: 2019-08

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)