Pilot Study on the Effect of Early FES Cycling After Acute Spinal Cord Injury on Neuromuscular Preservation and Neurorecovery

Brief Summary

Detailed Description

Spinal cord injury (SCI) usually results in weakness or paralysis in the legs and/or arms, depending on the level and severity of the damage to the spinal cord. In addition, people with SCI often develop several complications in the long term, such as muscle wasting (atrophy), loss of bone strength, pain, and spasticity. Despite the weakness or paralysis, the muscles in a person with SCI can be activated using electrical stimulation applied on the skin surface of the muscles. This technique is called functional electrical stimulation (FES) and can be used in combination with a bike to perform a cycling movement (FES cycling). People who have had an SCI for a long time (chronic SCI) already use FES cycling to exercise, and it is known that it can reverse muscle atrophy and has a wide range of health benefits. Furthermore, animal research suggests that starting exercise training early after new SCI may promote spinal cord recovery. However, not much is known about early FES cycling in humans, for example, if it could prevent muscle atrophy, pain or spasticity, and help with recovery of the spinal cord. Therefore, the investigators propose to study if early FES cycling may prevent these complications and help with spinal cord recovery. The study will recruit 36 participants with a new SCI, in 3 groups. The Early-FES group starts FES cycling early after injury (between 14 and 21 days after injury), and for a duration of 6 months. A Delayed-FES group starts FES cycling 3 months after enrolling in the study, and for a duration of 3 months. A Control group does not perform FES cycling. People with an acute, complete or incomplete SCI that resulted in paralysis from the waist down (paraplegia) or neck down (quadriplegia) will be considered. The Early and Delayed FES group will be recruited from the University of Alberta Hospital (UAH) where the FES bikes are available. Participants will be assigned by chance into Early and Delayed FES group. The control group will be mainly recruited from the Royal Alexandra Hospital, where the FES bikes are currently not available. The FES groups will perform FES cycling sessions 3 times per week (up to 1 hour per session) and receive standard care (typically including physical and occupational therapy). The Control group will only receive standard care. The FES cycling will be performed while the participants are lying in bed using a bed bike, or while sitting in a wheel chair using chair-based bike. Both systems use pedals that are strapped to the feet and an electrical stimulator to activate several muscles of both legs using electrodes attached to the skin. The following will be measured: 1) the size of the leg muscles and amount of fat in the legs using a CT scanner. 2) strength of the muscles using manual tests and by the electrical signals in the muscle. 3) spasticity by measuring electrical responses in the muscle when stimulated, as well as with clinical scales. 4) strength of the electrical connections between brain and spinal cord. 5) clinical measures such as the spinal injury classification, pain and reflexes. 6) response of participants to the FES cycling program. 7) cost and health care resources for the administration of early and delayed FES cycling. All 3 groups will undergo the same assessments. This pilot study will allow the investigators to study if early FES cycling, in addition to standard care, has greater benefits on the preservation and recovery of the leg muscles and spinal cord function than standard care only. The results of this pilot study may lead to the development of a multi-center clinical trial with early FES cycling after new SCI, which may have important and innovative implications in the future rehabilitation practice, improving the health, function and quality of life of persons with SCI.

Primary Outcomes

Secondary Outcomes

• SCI Classification at Baseline(Baseline)
• Sensory scores: Change from 3 months to 6 months(3 months)
• Pain intensity: Change from 3 months to 6 months(3 months)
• Walking Speed: Change from 0 to 3 months(3 months)
• Walking Speed: Change from 3 months to 6 months(3 months)
• SCI Classification at 6 months(6 months)
• Motor scores: Change from 0 to 3 months(3 months)
• Leg cross-sectional area thigh and calf: Change from 0 to 3 months(3 months)
• Spasticity self-report: Change from 3 months to 6 months(3 months)
• Depression at 6 months(6 months)
• Psychosocial status of participants as assessed by AQol-8D at 6 months(6 months)
• Motor scores: Change from 3 months to 6 months(3 months)
• Leg cross-sectional area thigh and calf: Change from 3 months to 6 months(3 months)
• Walking Capability: Change from 3 months to 6 months(3 months)
• SCI Classification at 3 months(3 months)
• Sensory scores: Change from 0 to 3 months(3 months)
• Pain intensity: Change from 0 to 3 months(3 months)
• Walking Capability: Change from 0 to 3 months(3 months)
• Spasticity self-report: Change from 0 to 3 months(3 months)
• Psychosocial status of participants as assessed by AQol-8D at 3 months(3 months)
• Depression at 3 months(3 months)
• Program Cost(6 months)