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Trial registered on ANZCTR


Registration number
ACTRN12611001079932
Ethics application status
Approved
Date submitted
17/10/2011
Date registered
18/10/2011
Date last updated
16/06/2016
Type of registration
Prospectively registered

Titles & IDs
Public title
SCIPA (Spinal Cord Injury and Physical Activity) Switch-On - Electrical Stimulation : Acute Care
Scientific title
Functional electrical stimulation (FES)-assisted cycling versus passive cycling following spinal cord injury: Change in muscle cross-sectional are of thigh and calf post-intervention compared with baseline post spinal cord injury.
Secondary ID [1] 273228 0
None
Universal Trial Number (UTN)
Trial acronym
SCIPA Switch-On
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Spinal Cord Injury 278982 0
Condition category
Condition code
Injuries and Accidents 279158 279158 0 0
Other injuries and accidents

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Group A: FES Cycling Group
Participants assigned to this group will undertake up to 60 minutes (excluding preparation time) of leg cycling 4 days/week for 12 weeks using a Hasomed RehaStim FES Unit attached to a MOTOmed cycle at a pedal cadence between 25-50 rev/min. This can be undertaken as a single session or split into two sessions per day, depending on the participant’s performance and the availability of staff. Surface electrodes will be applied to gluteal, quadriceps, and hamstrings muscles (not calves). Stimulation intensity will be gradually increased to a maximum of 140 mA, pulse width of 0.3 – 0.5ms and frequency of 35Hz and this will be sufficient to induce vigorous muscle contractions (Fornusek & Davis, 2008). Participants will exercise at the maximal power output possible at their level of recovery. Therapists will evaluate the degree of muscle contraction, power output and fatigue, and adjust parameters appropriately to maximise time, intensity, and power of training with a principle of overloading the muscle. When fatigue occurs, cycling can be stopped and then re-commenced after a 5 min break if muscle contraction can be elicited again. For participants with some degree of volitional muscle activity, the settings will be adjusted to ensure that resistance is maintained.
While patients are confined to bed, the MOTOmed Letto cycle will be attached to the end of the bed and patients will cycle whilst supine. The use of a similar cycle to exercise critically ill patients in ICU has resulted in no adverse events (Burtin et al. 2009). Once mobilised, patients may use an upright RT300 or MOTOmed Viva cycle attached to their wheelchair.
Intervention code [1] 269550 0
Rehabilitation
Intervention code [2] 269551 0
Treatment: Devices
Comparator / control treatment
Group B: Passive Cycling Group
Participants allocated to this group will undertake up to 60 minutes (excluding preparation time) passive cycling 4 days/week at identical pedal cadence to Group A. This can be undertaken as a single session or split into two sessions per day, depending on the participant’s performance and the availability of staff. Cycling while the participant is confined to bed will be with the MOTOmed Letto device and, once mobilised into a wheelchair, may use the RT300 or MOTOmed Viva cycle but without FES-evoked contractions.
Control group
Active

Outcomes
Primary outcome [1] 279800 0
Change in muscle cross-sectional area of thigh and calf post-intervention (3 months) compared to baseline.

This will be measured by MRI and DEXA scans as well as body measurements (skin folds and leg volumes).
Timepoint [1] 279800 0
After 12 weeks of treatment compared to baseline.
Secondary outcome [1] 294471 0
Changes in ASIA Impairtment Scale (AIS) motor and sensory scores post-intervention (3 months) compared to baseline.
Note: ASIA = American Spinal Cord Association

This will be measured by completing an ASIA assessment.
Timepoint [1] 294471 0
After 12 weeks of treatment compared to baseline.
Secondary outcome [2] 294472 0
Changes in intramuscular fat post-intervention (3 months) compared to baseline.

This will be measured by DEXA scans as well as body measurements (skin folds and leg volumes).
Timepoint [2] 294472 0
12 weeks of treatment compared to baseline.
Secondary outcome [3] 294473 0
Changes in lean muscle mass post-intervention (3 months) compared to baseline.

This will be measured by DEXA scans as well as body measurements (skin folds and leg volumes).
Timepoint [3] 294473 0
After 12 weeks of treatment compared to baseline.
Secondary outcome [4] 294474 0
Changes in total fat mass post-intervention (3 months) compared to baseline.

This will be measured by DEXA scans as well as body measurements (skin folds and leg volumes).
Timepoint [4] 294474 0
After 12 weeks of treatment compared to baseline.
Secondary outcome [5] 294475 0
Changes in leg volumes post-intervention (3 months) compared to baseline.

This will be measured by body measurements (skin folds and leg volumes).
Timepoint [5] 294475 0
After 12 weeks of treatment compared to baseline.

Eligibility
Key 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
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key 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
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Participants will participate in pre-screening, then screening and baseline visits prior to randomisation. Eligible participants will be randomised to one of two groups: 1. Group A - FES-Cycling or 2. Group B - Passive-Cycling. Randomisation will be stratified by injury status (ASIA A, B or C) and co-ordinated by a central randomisation unit. Upon completion of all screening and baseline assessments and suitability checks, a participant eligibility checklist will be completed by the Site Coordinator and signed by the Principal Investigator. This checklist will be sent to the central randomisation unit who will notify the Site Coordinator of treatment assignment. This will not be disclosed to the Blinded Assessors.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation by using a randomization table created by a computer software (i.e. computerised sequence generation)

Participants will be stratefied by injury status (ASIA A, B or C)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint(s)
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment postcode(s) [1] 4649 0
3084
Recruitment postcode(s) [2] 4650 0
4102
Recruitment postcode(s) [3] 4651 0
6008
Recruitment outside Australia
Country [1] 3911 0
New Zealand
State/province [1] 3911 0
Christchurch

Funding & Sponsors
Funding source category [1] 270050 0
Other Collaborative groups
Name [1] 270050 0
Transport Accident Commission (TAC)
Address [1] 270050 0
Level 2, 60 Brougham Street
PO Box 2314
Geelong VIC 3220
Country [1] 270050 0
Australia
Funding source category [2] 270051 0
Government body
Name [2] 270051 0
National Health and Medical Research Council (NH&MRC)
Address [2] 270051 0
GPO Box 1421
Canberra ACT 2601
Country [2] 270051 0
Australia
Primary sponsor type
University
Name
The University of Melbourne
Address
The University of Melbourne, Parkville, VIC 3101
Country
Australia
Secondary sponsor category [1] 269019 0
None
Name [1] 269019 0
Address [1] 269019 0
Country [1] 269019 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 272009 0
Austin Health Research Ethics Committee
Ethics committee address [1] 272009 0
Henry Buck Building
Austin Hospital
145 Studley Road
Heidelberg
Victoria, 3084
Ethics committee country [1] 272009 0
Australia
Date submitted for ethics approval [1] 272009 0
27/10/2011
Approval date [1] 272009 0
20/02/2012
Ethics approval number [1] 272009 0
H2012/04476

Summary
Brief summary
This study is a multi-centre, assessor-blinded, randomised controlled Phase I trial in people with spinal cord injury. This study is funded by a grant from the Victorian Neurotrauma Initiative. A total of 50 participants with complete or incomplete spinal cord injury will be randomised into two groups: an experimental group and a control group. The control group will undertake a passive cycling program using a bed bike while in the acute ward and an upright bike once they progress to rehabilitation. The experimental group will undertake a FES-assisted cycling program using a bed bike while in the acute ward and an upright bike once they progress to rehabilitation. Both programs will consist of 60 minutes of training 4 times per week for 12 weeks. Training will commence once the participant is considered medically stable (a minimum 5 days post-injury, maximum 4 weeks post-injury).
The main objective of the study is to determine the relative effectiveness of FES-assisted cycling compared to passive cycling on muscle cross-sectional area of thigh and calf.
The total study duration is 2 years, including an 18month recruitment period, a 12 week treatment period and post-intervention assessments (within a week of last treatment).
Trial website
www.scipa.unimelb.edu.au
Trial related presentations / publications
MP Galea,, SA Dunlop, R Marshall, J Clark, L Churilov. Early exercise after spinal cord injury (‘Switch-On’): study protocol for a randomised controlled trial. Trials (2015) 16:7

Results publication is pending submission.
Public notes

Contacts
Principal investigator
Name 33274 0
Prof Mary Galea
Address 33274 0
Department of Medicine (Royal Melbourne Hospital)
The University of Melbourne
Royal Park Campus
34-54 Poplar Road
Parkville, Victoria, 3052
Australia
Country 33274 0
Australia
Phone 33274 0
+61 3 8387 2017
Fax 33274 0
Email 33274 0
m.galea@unimelb.edu.au
Contact person for public queries
Name 16521 0
Mrs Melanie Hurley
Address 16521 0
Neuroscience Trials Australia (SCIPA / University of Melbourne)
(a business unit within the Florey Institute of Neuroscience and Mental Health) Melbourne Brain Centre - Austin Campus
245 Burgundy Street
Heidelberg VIC 3084
Country 16521 0
Australia
Phone 16521 0
+61 3 9035 7235
Fax 16521 0
+61 3 9496 2881
Email 16521 0
mhurley@unimelb.edu.au
Contact person for scientific queries
Name 7449 0
Prof Prof Mary Galea
Address 7449 0
Department of Medicine (Royal Melbourne Hospital)
The University of Melbourne
Royal Park Campus
34-54 Poplar Road
Parkville, Victoria, 3052
Australia
Country 7449 0
Australia
Phone 7449 0
+61 3 8387 2017
Fax 7449 0
Email 7449 0
m.galea@unimelb.edu.au

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary