None listed
Conditions
Brief summary
Spinal cord injury results in loss of motor, sensory and autonomic function below the level of the lesion. This has serious implications on activities of daily living and psychological well being. Specifically, significant loss of lower limb motor control leads to marked changes in peripheral circulation, increasing the risk of skin breakdown, pressure ulcers and limiting footwear options. Functional electrical stimulation (FES) cycling is an increasingly popular part of rehabilitation programs following recent spinal cord injury. The functional electrical stimulation cycling unit uses electrodes on the main muscle groups in the lower limbs to cause contractions of paralysed muscles to generate a cycling motion. There is mounting anecdotal evidence to support the use of FES cycling to improve urine output, and reduce lower limb swelling and spasticity. However, there is little good quality research to confirm these claims. Thus the purpose of this study is to determine the effect of FES lower limb cycling on urine output, lower limb swelling and spasticity. The results of this study will have implications for the rehabilitation of people following spinal cord injury. In particular, they will provide high-quality evidence to guide clinical practice and assist with prescription and recommendations for FES cycling.
Interventions
The intervention phase will involve two weeks of FES cycling for 30-45 minutes, four times a week. The actual duration of individual FES cycling sessions will be determined by the participant's capacity to continue and will be supervised by their treating therapist.
Sponsors
Associate Professor Lisa Harvey
Study design
Allocation
Randomised controlled trial
Intervention model
Crossover
Primary purpose
Treatment
Masking
Blinded (masking used)
Eligibility
Sex/Gender
All
Age
16 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Participants will be included if; - they have sustained a SCI lesion (traumatic or non traumatic) within the preceding 6 months - they are currently receiving inpatient rehabilitation and will remain an inpatient for at least 8 weeks after initial screening as part of their standard rehabilitation and medical treatment. - their legs muscles are responsive to Electrical Stimulation and can tolerate >20mins of FES cycling over an hour period. - they have a diagnosed AIS A, B or C lesion with less than 5/50 lower limb strength according to the International Standards for Neurological Classification of SCI. - they are 16 years of age or over and are able to provide informed consent. - they are deemed medically fit to participate in the study as per their treating Consultant. - they are able to speak sufficient English to allow them to participate in the study without the assistance of a translator.
Exclusion criteria
Participants will be excluded if they; - have significant lower limb injury, pathology or contracture limiting use of FES cycling (e.g., decreased range of motion, recent or unhealed fracture, open wound or severe osteoporosis) - have a pacemaker / stimulator or are pregnant. are non-compliant with their inpatient rehabilitation program. - have diabetes, hyponatremia or severe renal / hepatic dysfunction. - have uncontrolled autonomic dysreflexia - have a cognitive impairment or other medical condition including psychiatric, behavioural or terminal illness limiting adherence to the Protocol or participation in the study .
Outcome results
None listed