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Trial registered on ANZCTR


Registration number
ACTRN12612001163897
Ethics application status
Approved
Date submitted
22/10/2012
Date registered
1/11/2012
Date last updated
14/07/2016
Type of registration
Prospectively registered

Titles & IDs
Public title
Does cycling with electrical stimulation (ES) improve strength and walking ability in people with an acquired brain injury? A randomised controlled trial
Scientific title
Does cycling with electrical stimulation (ES) improve strength and walking ability in people with an acquired brain injury? A randomised controlled trial
Secondary ID [1] 281399 0
nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Acquired brain injury 287637 0
Condition category
Condition code
Physical Medicine / Rehabilitation 287971 287971 0 0
Physiotherapy
Neurological 288088 288088 0 0
Other neurological disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Electrical Stimulation (ES) Cycling

A 30 min incremental progressive, individualised ES cycling program performed five times a week for four weeks as well as usual care. ES Cycling involves applying a small electrical current through pads attached to the skin over 4 muscle groups on the affected leg. This will be applied from 10-15 minutes initially increasing to 30 minutes 5 times weekly over a 4 week period. The parameters will be individualized and adjusted according to the participants' comfort levels. It will take approximately 10 minutes to set up a participant on the ES cycle however once set up the therapist will be able to provide one-to-one assistance to other people whilst supervising participants. This will allow more people to receive supervised exercise simultaneously.
Intervention code [1] 285882 0
Rehabilitation
Comparator / control treatment
The control group will receive usual physiotherapy care only. Usual care will consist of a daily one-hour strength, endurance, fitness, balance, dexterity and activities of daily living (ADL) re-training session administered by a Physiotherapist for 4 weeks.
Control group
Active

Outcomes
Primary outcome [1] 288182 0
Quadriceps strength will be measured using dynamometry, a hand-held device which is easy to use and not harmful to the participant.
Timepoint [1] 288182 0
Measured prior to randomization and again following the intervention period of 4 weeks.
Primary outcome [2] 288183 0
Walking ability will be assessed using the transfers and locomotion items of the Functional Independence Measure (FIM).
Timepoint [2] 288183 0
Measured prior to randomization and again following the intervention period of 4 weeks.
Secondary outcome [1] 299556 0
Spasticity will be assessed using the Tardieu scale
Timepoint [1] 299556 0
Measured prior to randomization and again following the intervention period of 4 weeks.
Secondary outcome [2] 299557 0
Global lower limb strength will be measured with manual muscle testing.
Timepoint [2] 299557 0
Measured prior to randomization and again following the intervention period of 4 weeks.

Eligibility
Key inclusion criteria
1. diagnosis of a first time stroke or any other acquired brain injury that is not progressive resulting in hemiparesis
2. acute event < 6 months before the study onset
3. sufficient cognition to consent (as evaluated by a physician) or consent will be obtained from the next of kin.
4. sufficient communication to indicate yes/no verbally or via gestures possible discomfort.
5. able to sit supported for 40 mins
Minimum age
18 Years
Maximum age
100 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. limited joint range of movement or musculoskeletal conditions that would prevent pedaling
2. cardiac pacemakers unless permission to participate by a medical officer
3. skin reaction to the electrodes
4. inability to tolerate or be stimulated by electrical stimulation
5. poor skin viability
6. pregnancy

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)
Allocation will involve contacting the holder of the allocation schedule who is in a central administration unit in another building on-site. This person will not have any other involvement in the trial.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Permuted block randomisation using a randomization table created by computer software
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint(s)
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)
NSW

Funding & Sponsors
Funding source category [1] 286156 0
Self funded/Unfunded
Name [1] 286156 0
Address [1] 286156 0
Country [1] 286156 0
Primary sponsor type
Individual
Name
Davide de Sousa
Address
Graythwaite Rehabilitation Centre
Ryde Hospital
Denistone Road
Eastwood
NSW
2122
Country
Australia
Secondary sponsor category [1] 284965 0
Individual
Name [1] 284965 0
Lisa Harvey
Address [1] 284965 0
Rehabilitation Studies Unit
PO Box 6
Ryde NSW 1680
Country [1] 284965 0
Australia
Secondary sponsor category [2] 284966 0
Individual
Name [2] 284966 0
Simone Dorsch
Address [2] 284966 0
Australian Catholic University
Faculty of Health Sciences
ACU
PO Box 968
North Sydney NSW 2059
Country [2] 284966 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 288214 0
Northern Sydney Coast Human Research Ethics Committee
Ethics committee address [1] 288214 0
Level 13, Kolling Building (6)
Royal North Shore Hospital
Pacific Highway,
St Leonards NSW 2065
Ethics committee country [1] 288214 0
Australia
Date submitted for ethics approval [1] 288214 0
12/06/2012
Approval date [1] 288214 0
29/08/2012
Ethics approval number [1] 288214 0
1207-218M
Ethics committee name [2] 288261 0
The University of Sydney HREC
Ethics committee address [2] 288261 0
Level 6, Jane Foss Russell Building - G02 The University of Sydney NSW 2006
Ethics committee country [2] 288261 0
Australia
Date submitted for ethics approval [2] 288261 0
12/09/2012
Approval date [2] 288261 0
11/10/2012
Ethics approval number [2] 288261 0
Protocol No. 15332

Summary
Brief summary
Primary objective:
To determine whether four weeks of ES cycling in addition to usual care results in greater improvements in quadriceps strength and walking ability in people with an acquired brain injury compared to usual physiotherapy alone.

Secondary objective:
To determine whether four weeks of ES cycling in addition to usual care improves global lower limb strength and reduces spasticity in people with an acquired brain injury compared to usual physiotherapy alone.

The null hypothesis is that application of ES cycling in addition to usual physiotherapy will not improve people’s lower limb strength and walking ability more than usual physiotherapy alone.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 34835 0
Mr Davide de Sousa
Address 34835 0
Graythwaite Rehabilitation Centre
Ryde Hospital
Denistone Road
Eastwood
NSW
2122
Country 34835 0
Australia
Phone 34835 0
+61298587144
Fax 34835 0
Email 34835 0
davide.desousa@health.nsw.gov.au
Contact person for public queries
Name 18082 0
Mr Davide de Sousa
Address 18082 0
Graythwaite Rehabilitation Centre
Ryde Hospital
Denistone Road
Eastwood
NSW
2122
Country 18082 0
Australia
Phone 18082 0
+61298587144
Fax 18082 0
+61298587558
Email 18082 0
davide.desousa@health.nsw.gov.au
Contact person for scientific queries
Name 9010 0
A/Prof A/Prof Lisa Harvey
Address 9010 0
Rehabilitation Studies Unit
Northern Clinical School
Sydney School of Medicine
Royal Rehabilitation Centre Sydney
PO Box 6
Ryde NSW 1680
Country 9010 0
Australia
Phone 9010 0
+61298099099
Fax 9010 0
+61298099037
Email 9010 0
lisa.harvey@sydney.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