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Trial registered on ANZCTR


Registration number
ACTRN12611000923965
Ethics application status
Approved
Date submitted
25/07/2011
Date registered
29/08/2011
Date last updated
26/09/2011
Type of registration
Retrospectively registered

Titles & IDs
Public title
The effectiveness of functional electrical stimulation cycling on urine output, lower limb swelling and spasticity in recent spinal cord injury: a randomised control trial.
Scientific title
The effectiveness of functional electrical stimulation cycling on urine output, lower limb swelling and spasticity in recent spinal cord injury: a randomised control trial.
Secondary ID [1] 262696 0
N/A
Universal Trial Number (UTN)
N/A
Trial acronym
N/A
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Spinal cord injury 270397 0
Condition category
Condition code
Physical Medicine / Rehabilitation 268540 268540 0 0
Physiotherapy
Neurological 270843 270843 0 0
Other neurological disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
Intervention code [1] 267045 0
Rehabilitation
Comparator / control treatment
Two weeks of usual rehabilitation. Usual rehabilitation commonly involves a combination of functional task retraining; strength and fitness training; maintenance of joint range of movement and muscle length. The rehabilitation program is tailored to the individual to optimise independence and quality of life.
This is a cross over trial where the order of intervention / control phases are randomised and separated by a one week wash out period.
Control group
Active

Outcomes
Primary outcome [1] 269288 0
Urine output as assessed by a blinded assessor. Measurements during both phases will be taken over a one hour period either immediately following FES cycling (if the participant is at the end of the experimental phase) or sitting quietly (if the participant is at the end of the control phase). Measurements during both phases will be performed while the participant is sitting quietly. Prior to each measurement, fluid intake will be restricted for 3 hours according to normal recommended intake for weight.
Timepoint [1] 269288 0
On four occasions, before and after both intervention and control phases.
Secondary outcome [1] 279304 0
Lower limb spasticity, as assessed by a blinded assessor using the Ashworth scale.
Timepoint [1] 279304 0
On four occasions, before and after both intervention and control phases.
Secondary outcome [2] 279305 0
Lower limb swelling, as assessed by a blinded assessor using circumferential measures.
Timepoint [2] 279305 0
On four occasions, before and after both intervention and control phases.
Secondary outcome [3] 279306 0
Patient perceptions of their spasticity using the patient reported impact of spasticity measure (PRISM).
Timepoint [3] 279306 0
On four occasions, before and after both intervention and control phases.
Secondary outcome [4] 279307 0
Participant perception of treatment effectiveness, participants will be asked to rate their perceived change since commencement of the trial on a 15 point scale.
Timepoint [4] 279307 0
At the final assessment.

Eligibility
Key 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.
Minimum age
16 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Fourteen participants from 2 NSW Spinal Units will be recruited. Possible participants will undergo a screening process and suitable participants will be invited to participate. Randomisation must occur within one week of initial screening and consent. Once the eligibility checklist is complete, eligible participants will be randomised to the order of experimental and control phases named phase one and phase two.
The randomisation schedule will be formulated by an independent person. Each participant’s allocation will be placed in sealed opaque and sequentially numbered envelopes that will be kept off-site. A participant will be entered into the trial when baseline details are logged, an envelope is opened and the phase order provided.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The simple randomisation schedule was computer generated.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
Phase
Phase 3
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
25/07/2011
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
14
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 267515 0
Self funded/Unfunded
Name [1] 267515 0
Country [1] 267515 0
Primary sponsor type
Individual
Name
Associate Professor Lisa Harvey
Address
Rehabilitation Studies Unit
Royal Rehabilitation Centre Sydney
PO Box 6
RYDE NSW
2112
Country
Australia
Secondary sponsor category [1] 268769 0
Individual
Name [1] 268769 0
Ms Keira Ralston
Address [1] 268769 0
Prince of Wales Hospital
Spinal Injuries Unit
Level 1 High Street, Clinical Services Building
Randwick
NSW 2031
Country [1] 268769 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 269482 0
University of Wollongong Human Research Ethics Committee
Ethics committee address [1] 269482 0
Ethics committee country [1] 269482 0
Australia
Date submitted for ethics approval [1] 269482 0
08/03/2011
Approval date [1] 269482 0
14/04/2011
Ethics approval number [1] 269482 0
HE11/037

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 32920 0
Address 32920 0
Country 32920 0
Phone 32920 0
Fax 32920 0
Email 32920 0
Contact person for public queries
Name 16167 0
Lisa Harvey
Address 16167 0
Rehabilitation Studies Unit
Northern Clinical School
Sydney School of Medicine
University of Sydney
PO Box 6, Ryde
NSW 1680
Country 16167 0
Australia
Phone 16167 0
+61 2 9809 9099
Fax 16167 0
Email 16167 0
lisa.harvey@sydney.edu.au
Contact person for scientific queries
Name 7095 0
Lisa Harvey
Address 7095 0
Rehabilitation Studies Unit
Northern Clinical School
Sydney School of Medicine
University of Sydney
PO Box 6, Ryde
NSW 1680
Country 7095 0
Australia
Phone 7095 0
+61 2 9809 9099
Fax 7095 0
Email 7095 0
lisa.harvey@sydney.edu.au

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.