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

Phase 3
Recruiting
Conditions
Spinal cord injury
Physical Medicine / Rehabilitation - Physiotherapy
Neurological - Other neurological disorders
Registration Number
ACTRN12611000923965
Lead Sponsor
Associate Professor Lisa Harvey
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Recruiting
Sex
All
Target Recruitment
14
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 .

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Secondary Outcome Measures
NameTimeMethod
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