Functional Electrical Stimulation Cycling in Acute Spinal Cord Injury; a Feasibility Study
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Spinal Cord Injury, Acute
- Sponsor
- Glasgow Caledonian University
- Enrollment
- 12
- Locations
- 1
- Primary Endpoint
- Change in Spinal Cord Injury Functional Ambulation Inventory (SCI- FAI)
- Last Updated
- 6 years ago
Overview
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.
Investigators
Aleksandra Dybus
REsearch Physiotherapist
Glasgow Caledonian University
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
Outcomes
Primary Outcomes
Change in Spinal Cord Injury Functional Ambulation Inventory (SCI- FAI)
Time Frame: baseline, 6 weeks, 12 weeks
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.
Secondary Outcomes
- ASIA Impairment Scale(baseline, 6 weeks, 12 weeks)
- Handheld dynamometry (HDD)(baseline, 6 weeks, 12 weeks)
- The Spinal Cord Independence Measure (SCIM III)(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)
- Trunk Impairment Scale (TIS)(baseline, 6 weeks, 12 weeks)
- Modified Ashworth scale (MAS)(baseline, 6 weeks, 12 weeks)
- Modified Tardieu Scale (MTS)(baseline, 6 weeks, 12 weeks)
- the Patients Global Impression of Change(12 weeks)