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Trial registered on ANZCTR

Registration number
Ethics application status
Date submitted
Date registered
Date last updated
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

Study type
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
Comparator / control treatment
Control: 2 hours of upper limb motor trainining (predominately shoulder/elbow based) per week for 6 weeks.
Control group
Dose comparison

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

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
Both males and females
Can healthy volunteers participate?
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
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
Other design features
Type of endpoint(s)
Statistical methods / analysis

Recruitment status
Date of first participant enrolment
Date of last participant enrolment
Date of last data collection
Sample size
Accrual to date
Recruitment in Australia
Recruitment state(s)
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
Address [1] 1338 0
Butterfield St, Herston, Brisbane.
Country [1] 1338 0
Primary sponsor type
Government body
Queensland Health
Butterfield St, Herston, Brisbane
Secondary sponsor category [1] 1181 0
Name [1] 1181 0
Address [1] 1181 0
Country [1] 1181 0

Ethics approval
Ethics application status
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
Date submitted for ethics approval [1] 2687 0
Approval date [1] 2687 0
Ethics approval number [1] 2687 0
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
Date submitted for ethics approval [2] 296118 0
Approval date [2] 296118 0
Ethics approval number [2] 296118 0

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

Principal investigator
Name 35879 0
Mr Leo Ross
Address 35879 0
QEII Jubilee Hospital, Brisbane, Australia
Country 35879 0
Phone 35879 0
+61 731826148
Fax 35879 0
Email 35879 0
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
Phone 10214 0
+61 731826148
Fax 10214 0
+61 7 47962621
Email 10214 0
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
Phone 1142 0
+61 731826148
Fax 1142 0
+61 7 47962621
Email 1142 0

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