SCIPA (Spinal Cord Injury and Physical Activity) Switch-On - Electrical Stimulation : Acute Care

Not Applicable

Completed

• Conditions: Spinal Cord Injury; Injuries and Accidents - Other injuries and accidents

• Registration Number: ACTRN12611001079932
• Lead Sponsor: The University of Melbourne

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2011-10-18
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

Participants will be included if they:
a)Have sustained a complete (AIS A) or incomplete SCI (AIS B, C) above T12 no more than 3 weeks previously
b)Have undergone internal fixation of spinal fracture or whose fracture is considered sufficiently stable
c)Are medically stable
d)Are able to provide informed consent
e)Have medical and surgical clearance to participate in the study

Exclusion Criteria

Participants will be excluded if they:
a)Are under 18 years of age
b)Are classified as AIS D at baseline
c)Are in a halo or receiving any other traction
d)Are in ICU
e)Have pressure ulcers
f)Have peripheral nerve lesion
g)Have long bone or pelvic fracture
h)Have lower limb amputation
i)Have had previous FES to lower limbs
j)Are on a ventolator
k)Have metabolic bone disease, including lytic or renal bone disease, or senile osteoporosis
l)Have had exposure to drugs that affect bone metabolism (amino-bisphosphonate, high dose glucocorticoids, cyclosporine, anti-epileptic drugs [AEDs])
m)Have any contraindications to FES or MRI (cardiac pacemaker, epilepsy, pregnancy, skin grafts, lower limb injuries)
n)Have any other contraindications to participating in exercise programs, or outcome assessments, as advised by the treating physician (e.g. autonomic hyper-reflexia, suboptimal oxygen saturation)
o)English language competency insufficient to understand research procedures and provide informed consent.
p)Have any other serious medical condition including malignancies, psychiatric, behavioural or drug-dependency problems, which are likely to influence the participant’s ability to cooperate or in the opinion of the study investigator would prevent adherence to the Protocol.
q)Are participating in any other therapy (including alternative therapies) or taking medications (including herbal preparations) that are not considered to be standard care as per the protocol.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in muscle cross-sectional area of thigh and calf post-intervention (3 months) compared to baseline.<br><br>This will be measured by MRI and DEXA scans as well as body measurements (skin folds and leg volumes).[After 12 weeks of treatment compared to baseline.]