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Trial registered on ANZCTR


Registration number
ACTRN12609000495224
Ethics application status
Approved
Date submitted
19/05/2009
Date registered
22/06/2009
Date last updated
10/12/2014
Type of registration
Prospectively registered

Titles & IDs
Public title
A bi-modal approach to treat and prevent wrist contracture in adults with acquired brain injury: a randomised controlled trial
Scientific title
Does a bi-modal approach combining electrical stimulation and splinting produce greater increases in passive wrist extension range of motion compared to splinting alone in adults with acquired brain injury: a randomised controlled trial
Secondary ID [1] 796 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Contracture after acquired brain injury 4238 0
Condition category
Condition code
Physical Medicine / Rehabilitation 4460 4460 0 0
Physiotherapy

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants in the splinting and electrical stimulation group will receive a 4-week programme of an hour electrical stimulation to wrist and finger extensors plus 12 hours of hand splinting per day, 5-7 days a week. Customised hand splints will be used. The splints will be worn during electrical stimulation and generally at night. However, splinting time may need to be varied to minimise interference with hygiene and therapy. Wrists will be stretched to maximum tolerable extension while in a splint. Electrical stimulation will be applied using the Neuro Trac Sports simulation unit at a frequency of 50hz. The amplitude of stimulation will be set at a level to achieve maximum tolerable contractions.
Intervention code [1] 3961 0
Rehabilitation
Intervention code [2] 3962 0
Treatment: Devices
Intervention code [3] 3963 0
Prevention
Comparator / control treatment
Participants in the splinting alone group will receive hand splinting 12 hours a day, 5 -7 days a week, over a 4-week period. Customised hand splints will be used. The splints will be worn generally at night. However, splinting time may need to be varied to minimise interference with hygiene and therapy. Wrists will be stretched to maximum tolerable extension while in a splint.
Control group
Active

Outcomes
Primary outcome [1] 5340 0
Extensibility of the extrinsic wrist and finger flexor muscles. This will be determined by measuring the passive wrist extension range at a torque of 3Nm with fingers in full extension.
Timepoint [1] 5340 0
At baseline, at the end of the 4-week intervention period (i.e., post-intervention) and 2 weeks later (i.e., follow-up).
Secondary outcome [1] 8972 0
Spasticity will be rated using the Tardieu Scale.
Timepoint [1] 8972 0
At baseline, at the end of the 4-week intervention period (i.e., post-intervention) and 2 weeks later (i.e., follow-up).
Secondary outcome [2] 8973 0
Strength of wrist extensors will be determined with a dynamometer.
Timepoint [2] 8973 0
At the end of the 4-week intervention period (i.e., post-intervention) and 2 weeks later (i.e., follow-up).
Secondary outcome [3] 242080 0
Motor control will be assessed using the hand movement item of the Motor Assessment Scale.
Timepoint [3] 242080 0
At the end of the 4-week intervention period (i.e., post-intervention) and 2 weeks later (i.e., follow-up).
Secondary outcome [4] 242081 0
Global perceived effect of treatment will be collected from participants or the person responsible for them and treating physiotherapists using two separate questionnaires.
Timepoint [4] 242081 0
At baseline, at the end of the 4-week intervention period (i.e., post-intervention) and 2 weeks later (i.e., follow-up).
Secondary outcome [5] 242082 0
General perception on credibility of interventions will be collected from participants or the person responsible for them and treating physiotherapists using two separate questionnaires.
Timepoint [5] 242082 0
At baseline, at the end of the 4-week intervention period (i.e., post-intervention).
Secondary outcome [6] 242083 0
Extensibility of the extrinsic wrist and finger flexor muscles. This will be determined by measuring the passive wrist extension range at a torque of 1Nm with fingers in full extension.
Timepoint [6] 242083 0
At baseline, at the end of the 4-week intervention period (i.e., post-intervention) and 2 weeks later (i.e., follow-up).
Secondary outcome [7] 242085 0
Extensibility of the extrinsic wrist and finger flexor muscles. This will be determined by measuring the passive wrist extension range at a torque of 2Nm with fingers in full extension.
Timepoint [7] 242085 0
At baseline, at the end of the 4-week intervention period (i.e., post-intervention) and 2 weeks later (i.e., follow-up).

Eligibility
Key inclusion criteria
-first diagnosis of stroke or traumatic brain injury
-weakness of wrist and finger extensors (inability to extend wrist fully in a gravity eliminated position)
-presence of reduced flexibility, spasticity (Tardieu scale score >1) or dystonia in the wrist and finger flexor muscles
-inpatient rehabilitation stay anticipated to be of at least 4 weeks
-ability to participate in a splinting regimen and an electrical stimulation programme
-passive wrist extension to at least neutral with fingers extended (ie. able to place the hand with wrist in neutral and fingers extended on a flat surface)
-informed consent from the participants or their person responsible
Minimum age
16 Years
Maximum age
85 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
medical conditions that limit compliance with a hand splint or electrical stimulation;
recent wrist or finger fractures; fixed flexion deformities in the individual finger joints; previous wrist problems that limit passive wrist range of motion.

Study design
Purpose of the study
Prevention
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 responsible 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. After completion of the baseline assessment, participants will be randomly allocated to one of the two groups: splinting and electrical stimulation (experimental) and splinting 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 the baseline assessment.
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 the 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
15/07/2009
Actual
15/07/2009
Date of last participant enrolment
Anticipated
15/07/2011
Actual
17/12/2011
Date of last data collection
Anticipated
Actual
Sample size
Target
36
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 3252 0
Royal Rehabilitation Hospital - Coorabel/Moorong - Ryde
Recruitment hospital [2] 3253 0
Liverpool Hospital - Liverpool
Recruitment hospital [3] 3254 0
Westmead Hospital - Westmead
Recruitment postcode(s) [1] 1401 0
2112
Recruitment postcode(s) [2] 1402 0
2041
Recruitment postcode(s) [3] 1403 0
2170

Funding & Sponsors
Funding source category [1] 4419 0
Government body
Name [1] 4419 0
Lifetime Care and Support Authority of NSW
Country [1] 4419 0
Australia
Primary sponsor type
Government body
Name
Lifetime Care and Support Authority of NSW
Address
Level 24, 580 George Street, Sydney NSW 2000
Country
Australia
Secondary sponsor category [1] 3978 0
Hospital
Name [1] 3978 0
Royal Rehabilitation Centre Sydney
Address [1] 3978 0
59 Charles Street, RYDE, NSW 2112
Country [1] 3978 0
Australia
Other collaborator category [1] 540 0
University
Name [1] 540 0
Rehabilitation Studies Unit, Northern Clinical School, Sydney Medical School, University of Sydney, Australia
Address [1] 540 0
PO Box 6 RYDE NSW 1680
Country [1] 540 0
Australia
Other collaborator category [2] 671 0
Other Collaborative groups
Name [2] 671 0
The George Institute for International Health
Address [2] 671 0
PO box M201, Misseden Road, Sydney NSW 2050
Country [2] 671 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 6468 0
Hawkesbury Human Research Ethics Committee of Northern Sydney Central Coast Health
Ethics committee address [1] 6468 0
Level 4, Vindin House, Royal North Shore Hospital, Pacific Highway, St Leonards NSW 2065
Ethics committee country [1] 6468 0
Australia
Date submitted for ethics approval [1] 6468 0
Approval date [1] 6468 0
11/12/2008
Ethics approval number [1] 6468 0
Protocol 0811-231M

Summary
Brief summary
The primary objective of the project is to determine the benefit of using a bi-modal approach for treating and preventing contracture in adults with acquired brain injury. A multi-centre randomised controlled study with concealed allocation and assessor blinding will be conducted. In this study, the wrist is selected as a model to assess if a bi-modal programme (splinting and electrical stimulation) is more effective than usual care (splinting alone). The participants are people with acquired brain injury admitted to the rehabilitation units of Royal Rehabilitation Centre Sydney, Liverpool Hospital and Balmain hospital.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 29221 0
Mrs Joan Leung
Address 29221 0
Royal Rehabilitation Centre, 235 Morrison Road, RYDE NSW 2112
Country 29221 0
Australia
Phone 29221 0
+61 2 98099020
Fax 29221 0
Email 29221 0
[email protected]
Contact person for public queries
Name 12468 0
Joan Leung
Address 12468 0
Brain Injury Unit, Royal Rehabilitation Centre Sydney, 59 Charles Street, RYDE 2112, NSW, Australia
Country 12468 0
Australia
Phone 12468 0
+61 2 98089215
Fax 12468 0
+61 2 98099027
Email 12468 0
[email protected]
Contact person for scientific queries
Name 3396 0
Joan Leung
Address 3396 0
Brain Injury Unit, Royal Rehabilitation Centre Sydney, 59 Charles Street, RYDE 2112, NSW, Australia
Country 3396 0
Australia
Phone 3396 0
+61 2 98089215
Fax 3396 0
+61 2 98099027
Email 3396 0
[email protected]

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
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