ANZCTR - Registration

Please note the ANZCTR will be unattended from Friday 20 December 2024 for the holidays. The Registry will re-open on Tuesday 7 January 2025. Submissions and updates will not be processed during that time.

Registering a new trial?

To achieve prospective registration, we recommend submitting your trial for registration at the same time as ethics submission.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers

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]

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)

Condition category

Condition code

Neurological

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]

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]

Action Research Armtest score

Timepoint [1]

At 6 weeks post treatment

Primary outcome [2]

Hand strength

Timepoint [2]

At 6 weeks post treatment

Secondary outcome [1]

1.Passive extensibility of wrist and finger flexors.

Timepoint [1]

At 6 weeks post

Secondary outcome [2]

2. Wolf Motor Function Test score

Timepoint [2]

At 6 weeks post

Secondary outcome [3]

3. Canadian Occupational Performance

Timepoint [3]

At 6 weeks post

Secondary outcome [4]

4. Disability of Arm, Schoulder, Hand score

Timepoint [4]

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?

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

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

QLD

Recruitment hospital [1]

The Townsville Hospital - Douglas

Funding & Sponsors

Funding source category [1]

Government body

Name [1]

Queensland Health

Address [1]

Butterfield St, Herston, Brisbane.

Country [1]

Australia

Primary sponsor type

Government body

Name

Queensland Health

Address

Butterfield St, Herston, Brisbane

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Nil

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

The Townsville Health Service District Institutional Ethics Committee

Ethics committee address [1]

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

Approval date [1]

22/02/2006

Ethics approval number [1]

01/06

Ethics committee name [2]

The Townsville Hospital HREC

Ethics committee address [2]

The Townsville Hospital, Douglas, Townsville

Ethics committee country [2]

Australia

Date submitted for ethics approval [2]

06/01/2006

Approval date [2]

22/02/2006

Ethics approval number [2]

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

Mr Leo Ross

Address

QEII Jubilee Hospital, Brisbane, Australia

Country

Australia

Phone

+61 731826148

Fax

leo.ross@health.qld.gov.au

Contact person for public queries

Name

Leo F Ross

Address

Department of Occupational Therapy, QEII Jubilee Hospital. Brisbane, QLD, Australia

Country

Australia

Phone

+61 731826148

Fax

+61 7 47962621

leo.ross@health.qld.gov.au

Contact person for scientific queries

Name

Leo Ross

Address

Department of Occupational Therapy, QEII Jubilee Hospital. Brisbane, QLD, Australia

Country

Australia

Phone

+61 731826148

Fax

+61 7 47962621

leo.ross@health.qld.gov.au

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.

Trial Review

Registering a new trial?

Documents added manually

Documents added automatically