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Trial registered on ANZCTR


Registration number
ACTRN12608000637347
Ethics application status
Approved
Date submitted
19/09/2008
Date registered
16/12/2008
Date last updated
12/11/2018
Date data sharing statement initially provided
12/11/2018
Date results provided
12/11/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
A multi-modality approach to prevent and treat contracture after traumatic brain injury: a randomised controlled trial
Scientific title
Does a multi-modality approach combining splinting, tilt table standing and electrical stimulation produce greater increases in passive dorsiflexion range of motion compared to tilt table standing alone in adults with traumatic brain injury: a randomised controlled trial
Secondary ID [1] 721 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Contracture after traumatic brain injury 3721 0
Condition category
Condition code
Physical Medicine / Rehabilitation 3893 3893 0 0
Physiotherapy

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants in the multi-modality group will receive a 6-week programme of 30 minutes of passive standing on a tilt table plus electrical stimulation to the ankle dorsiflexors while on the tilt table, and 12 hours of ankle splinting per day, 5 times per week. Electrical stimulation will be applied using the Neuro Trac Sports stimulation unit at a frequency of 50hz. The amplitude will be set at a level to produce maximum muscle contractions within the participants' tolerance. Electrical stimulation will not be used on participants who have contraindications (ie., rate controlled cardiac pacemaker and broken skin) or are unable to tolerate even the smallest amount of simulation. Commercially available splint (Formit) will be used to splint ankles. The ankles will be splinted in maximum tolerable dorsiflexion. The splints will generally be worn at night however this can be varied to minimise interference with hygiene and therapy. Different splints can be used if there are problems with the Formit and care sill be taken to ensure that they provide adequate stretch.
Intervention code [1] 3433 0
Treatment: Devices
Intervention code [2] 3434 0
Treatment: Other
Comparator / control treatment
Participants in the control group will be stood on a tilt table for 30 minutes 3 times a week over the 6-week period.
Control group
Active

Outcomes
Primary outcome [1] 4793 0
Passive ankle dorsiflexion range of motion will be measured with the application of 12Nm of torque.
Timepoint [1] 4793 0
At baseline, at the end of the 6-week intervention period (ie., post-intervention) and 4 weeks later (ie., follow-up)
Secondary outcome [1] 8088 0
Spasticity will be rated using the Tardieu Scale.
Timepoint [1] 8088 0
At baseline, at the end of the 6-week intervention period (ie., post-intervention) and 4 weeks later (ie., follow-up)
Secondary outcome [2] 8090 0
Activity limitations will be assessed in two ways:
i) Using the walking item of the Functional Independence Measures (FIM).
ii) Using the 10-metre walk test. Time taken to walk 10 metres at the fastest speed will be measured and used to calculate walking speed.
Timepoint [2] 8090 0
At baseline, at the end of the 6-week intervention period (ie., post-intervention) and 4 weeks later (ie., follow-up)
Secondary outcome [3] 8092 0
Global perceived effect of treatment will be collected from participants/person responsible for them and treating physiotherapists using two separate questionnaires.
Timepoint [3] 8092 0
At the end of the 6-week intervention period (ie., post-intervention) and 4 weeks later (ie., follow-up)
Secondary outcome [4] 8093 0
General perception of credibility of interventions will be collected from participants/person responsible for them and treating physiotherapists using two separate questionnaires.
Timepoint [4] 8093 0
At the end of the 6-week intervention period (ie., post-intervention) and 4 weeks later (ie., follow-up)
Secondary outcome [5] 8437 0
Passive ankle dorsiflexion range of motion will be measured with the application of 3, 5, 7 and 9 Nm of torque.
Timepoint [5] 8437 0
At baseline, at the end of the 6-week intervention period (ie., post-intervention) and 4 weeks later (ie., follow-up).

Eligibility
Key inclusion criteria
-Diagnosed with first traumatic brain injury
-Unable to walk 17 metres without physical assistance or 50 metres with supervision, ie., a score of <5 on the walking item of the Functional Independence Measure
-Have passive ankle dorsflexion range of motion <5 and >-15 degrees with the application of 12Nm of torque
-Willing and able to participate in a splinting regimen and tilt table standing
-Do not have unstable medical conditions or recent ankle fractures
-Currently receiving in-patient rehabilitation at the three brain injury units in Sydney
-Unlikely to be discharged in 6 weeks
-Provide consent to participate in the study (the participants or the person responsible for them)
Minimum age
16 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
-Passive ankle dorsiflexion range of motion >5 degrees
-Severe ankle contracture with passive ankle dorsiflexion range of motion <-15 degrees
-Unstable medical conditions or recent ankle fractures

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)
Potential participants who fit the eligibility criteria or the persons repsonsible for them will be given the Participant Information Sheets. An investigator will explain the study protocol to them. No pressure to participate will be placed on them under any circumstances. They will be informed that participation in the study is entirely voluntary and they are free to withdraw from the study at any stage without any effect on their current and future treatment. Those who agree to participate will be given the Consent Forms to sign and participate in the study.
Participants will be randomly allocated to one of two groups: splinting plus tilt table standing and electrical stimulation (experimental) and tilt table standing only (control). The allocation sequence is computer generated by a person not involved in recruitment and concealed using consecutively numbered, sealed and opaque envelopes. The envelopes will be kept off-site in a centralised registry and only opened by a person not involved in the study after the participants have completed all initial assessments.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The allocation sequence is computer generated by a person not involved in recruitment.
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
15/10/2008
Actual
1/01/2009
Date of last participant enrolment
Anticipated
Actual
20/09/2013
Date of last data collection
Anticipated
Actual
30/04/2014
Sample size
Target
36
Accrual to date
Final
36
Recruitment in Australia
Recruitment state(s)
Recruitment postcode(s) [1] 1165 0
2112
Recruitment postcode(s) [2] 1166 0
2145
Recruitment postcode(s) [3] 1167 0
2170

Funding & Sponsors
Funding source category [1] 3903 0
Hospital
Name [1] 3903 0
Rehabilitation and Disability Research Foundation Grant
Country [1] 3903 0
Australia
Primary sponsor type
Hospital
Name
Royal Rehabilitation Centre Sydney
Address
59 Charles Street, Ryde, NSW 2112
Country
Australia
Secondary sponsor category [1] 3502 0
Hospital
Name [1] 3502 0
Brain Injury Unit, Royal Rehabilitation Centre Sydney
Address [1] 3502 0
59 Charles Street, Ryde, NSW 2112
Country [1] 3502 0
Australia
Other collaborator category [1] 427 0
University
Name [1] 427 0
Rehabilitation Studies Unit, Northern Clinical School, Faculty of Medicine, University of Sydney, Australia
Address [1] 427 0
PO Box 6, RYDE NSW 1680
Country [1] 427 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 5957 0
Hawkesbury Human Research Ethics Committee of Northern Sydney Central Coast Health
Ethics committee address [1] 5957 0
Ethics committee country [1] 5957 0
Australia
Date submitted for ethics approval [1] 5957 0
19/03/2008
Approval date [1] 5957 0
14/07/2008
Ethics approval number [1] 5957 0
Protocol 0804-050M
Ethics committee name [2] 5958 0
Human Research Ethics Committee of the Sydney South West Area Health Service
Ethics committee address [2] 5958 0
Ethics committee country [2] 5958 0
Australia
Date submitted for ethics approval [2] 5958 0
05/08/2008
Approval date [2] 5958 0
Ethics approval number [2] 5958 0
Ethics committee name [3] 5959 0
Human Research Ethics Committee of the South West Area Health Service
Ethics committee address [3] 5959 0
Ethics committee country [3] 5959 0
Australia
Date submitted for ethics approval [3] 5959 0
30/07/2008
Approval date [3] 5959 0
Ethics approval number [3] 5959 0

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

Contacts
Principal investigator
Name 28956 0
Dr Joan Leung
Address 28956 0
Royal Rehabilitation Centre Sydney, 235 Morrison Road, RYDE 2112.
Country 28956 0
Australia
Phone 28956 0
+61 2 98099020
Fax 28956 0
Email 28956 0
Joan.leung@royalrehab.com.au
Contact person for public queries
Name 12113 0
Joan Leung
Address 12113 0
Brain Injury Unit, Royal Rehabilitation Centre Sydney, 59 Charles Street, RYDE 2112, NSW, Australia
Country 12113 0
Australia
Phone 12113 0
+61 2 9808 9215
Fax 12113 0
+61 2 9809 9027
Email 12113 0
Joan.Leung@royalrehab.com.au
Contact person for scientific queries
Name 3041 0
Joan Leung
Address 3041 0
Brain Injury Unit, Royal Rehabilitation Centre Sydney, 59 Charles Street, RYDE 2112, NSW, Australia
Country 3041 0
Australia
Phone 3041 0
+61 2 9808 9215
Fax 3041 0
+61 2 9809 9027
Email 3041 0
Joan.Leung@royalrehab.com.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Undecided
No/undecided IPD sharing reason/comment
It depends if there is a need or request or it.


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
199Study protocol    83187-(Uploaded-12-11-2018-08-20-14)-Study-related document.doc



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.