The effectiveness of functional electrical stimulation cycling on urine output, lower limb swelling and spasticity in recent spinal cord injury: a randomised control trial.

Associate Professor Lisa Harvey0 sites14 target enrollmentAugust 29, 2011

Overview

No summary available.

Registry

who.int

Start Date

August 29, 2011

End Date

TBD

Last Updated

6 years ago

Study Type

Interventional

Sex

All

Sponsor

Associate Professor Lisa Harvey

•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.

•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 .