Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12606000173594
Ethics application status
Approved
Date submitted
8/05/2006
Date registered
12/05/2006
Date last updated
12/10/2016
Type of registration
Retrospectively registered

Titles & IDs
Public title
Does an intensive, functionally-based motor training program improve the hand function of people with acquired brain impairment
Scientific title
Intensive, task-specific, functionally-based motor retraining to improve hand function following acquired brain impairment: a randomised controlled trial
Secondary ID [1] 290315 0
nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Acquired brain impairment (stroke, TBI, other ABI) 1146 0
Condition category
Condition code
Neurological 1226 1226 0 0
Brain

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Intensive, task-specific, functionally-based upper limb motor retraining.

Experimental:- 4 to 5.25 hours of upper limb motor training (predominately hand) per week for 6 weeks.
Intervention code [1] 1025 0
Rehabilitation
Comparator / control treatment
Control: 2 hours of upper limb motor trainining (predominately shoulder/elbow based) per week for 6 weeks.
Control group
Dose comparison

Outcomes
Primary outcome [1] 1663 0
Action Research Armtest score
Timepoint [1] 1663 0
At 6 weeks post treatment
Primary outcome [2] 1664 0
Hand strength
Timepoint [2] 1664 0
At 6 weeks post treatment
Secondary outcome [1] 2971 0
1.Passive extensibility of wrist and finger flexors.
Timepoint [1] 2971 0
At 6 weeks post
Secondary outcome [2] 2972 0
2. Wolf Motor Function Test score
Timepoint [2] 2972 0
At 6 weeks post
Secondary outcome [3] 2973 0
3. Canadian Occupational Performance
Timepoint [3] 2973 0
At 6 weeks post
Secondary outcome [4] 2974 0
4. Disability of Arm, Schoulder, Hand score
Timepoint [4] 2974 0
At 6 weeks post

Eligibility
Key inclusion criteria
1. ABI within past 5 years2. Unable to achieve a score greater than 45 (80%) on the Action Research Armtest3. Cognitively and physically able to participate in an intensive program of repetitive, task-specific motor re-training to improve hand function.
Population: All Adults, admitted to the Rehabilitation Service at The Townsville Hospital will be screened for eligibility.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Co-existing hand injury or disease other than ABI (e.g. fractures, MS, Rheumatoid Arthritis, peripheral nerve injury)2. Unlikely to be able to complete the 6 week study period (e.g. leaving town, medically unwell/unstable).

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)
Sequence generated by independent off site person and placed in sequentially numbered, sealed, opaque envelopes. Envelopes held off site, and allocation done via telephone.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Generated off site using random number function in MS Excell
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
27/02/2006
Actual
27/02/2006
Date of last participant enrolment
Anticipated
Actual
1/05/2007
Date of last data collection
Anticipated
Actual
19/06/2007
Sample size
Target
40
Accrual to date
Final
40
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 6816 0
The Townsville Hospital - Douglas

Funding & Sponsors
Funding source category [1] 1338 0
Government body
Name [1] 1338 0
Queensland Health
Country [1] 1338 0
Australia
Primary sponsor type
Government body
Name
Queensland Health
Address
Butterfield St, Herston, Brisbane
Country
Australia
Secondary sponsor category [1] 1181 0
None
Name [1] 1181 0
Nil
Address [1] 1181 0
Country [1] 1181 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 2687 0
The Townsville Health Service District Institutional Ethics Committee
Ethics committee address [1] 2687 0
Ethics committee country [1] 2687 0
Australia
Date submitted for ethics approval [1] 2687 0
Approval date [1] 2687 0
22/02/2006
Ethics approval number [1] 2687 0
01/06
Ethics committee name [2] 296118 0
The Townsville Hospital HREC
Ethics committee address [2] 296118 0
The Townsville Hospital, Douglas, Townsville
Ethics committee country [2] 296118 0
Australia
Date submitted for ethics approval [2] 296118 0
06/01/2006
Approval date [2] 296118 0
22/02/2006
Ethics approval number [2] 296118 0
01/2006

Summary
Brief summary
Many people who acquire a brain impairment (e.g. through stroke or traumatic injury) suffer significant paralysis and loss of function in their arms and hands. This loss of function is extremely disabling and effects many aspects of their daily lives. Therapists frequently provide motor retraining programs to try and help them regain functional use of their limbs. Unfortunately, there is considerable variation in the type and amount of therapy given. Current evidence also suggests that many of these patients do not regain their function despite participating in therapy. This randomised controlled trial will attempt to determine if an intensive daily program of specific functionally based hand exercises is able to improve the hand function of people with acquired brain impairment. It is hoped that its results will help to guide the current and future practice of Occupational and Physiotherapists working in rehabilitation. Final measured outcome assessor of the study is blinded.
Trial website
Trial related presentations / publications
Ross, L. Harvey, L. and Lannin, N. (2009) Do people with acquired brain impairment benefit from additional therapy specifically directed at the hand? A randomised controlled trial. Clinical Rehabilitation (23) 492-503

Ross, L. Harvey, L. and Lannin, N (2016) Strategies for increasing the intensity of upper limb task specific practice after acquired brain impairment: A secondary analysis from a randomised controlled trial
Public notes

Contacts
Principal investigator
Name 35879 0
Mr Leo Ross
Address 35879 0
QEII Jubilee Hospital, Brisbane, Australia
Country 35879 0
Australia
Phone 35879 0
+61 731826148
Fax 35879 0
Email 35879 0
[email protected]
Contact person for public queries
Name 10214 0
Mr Leo F Ross
Address 10214 0
Department of Occupational Therapy, QEII Jubilee Hospital. Brisbane, QLD, Australia
Country 10214 0
Australia
Phone 10214 0
+61 731826148
Fax 10214 0
+61 7 47962621
Email 10214 0
[email protected]
Contact person for scientific queries
Name 1142 0
Mr Leo Ross
Address 1142 0
Department of Occupational Therapy, QEII Jubilee Hospital. Brisbane, QLD, Australia
Country 1142 0
Australia
Phone 1142 0
+61 731826148
Fax 1142 0
+61 7 47962621
Email 1142 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
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.