Status:
UNKNOWN
Functional Electrical Stimulation Cycling in SCI
Lead Sponsor:
Glasgow Caledonian University
Collaborating Sponsors:
NHS Greater Glasgow and Clyde
Conditions:
Spinal Cord Injury, Acute
Paraplegia
Eligibility:
All Genders
18+ years
Phase:
NA
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 addr...
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 c...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 1 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2020
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT04064385
Start Date
June 1 2019
End Date
July 1 2020
Last Update
August 21 2019
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
The Queen Elizabeth National Spinal Injuries Unit
Glasgow, United Kingdom, G51 4TF