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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00222339

Registration number

NCT00222339

Ethics application status

Date submitted

13/09/2005

Date registered

22/09/2005

Date last updated

22/09/2005

Titles & IDs

Public title

Task-Related Training of Arm Use After Stroke

Scientific title

Task-Related Training of Arm Use After Stroke: a Randomised Controlled Trial

Secondary ID [1]

H2001/01313

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Stroke

Condition category

Condition code

Stroke

Haemorrhagic

Stroke

Ischaemic

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

Comparator / control treatment

Control group

Outcomes

Primary outcome [1]

Arm and hand function measured using the Motor Assessment Scale and the Chedoke-McMaster Impairment Inventory.

Timepoint [1]

Primary outcome [2]

Grip and pinch strength measured using dynamometers.

Timepoint [2]

Secondary outcome [1]

Dexterity measured using the NK Dexterity Board

Timepoint [1]

Secondary outcome [2]

Quality of Life measured using the Stroke-adapted Sickness Impact Profile.

Timepoint [2]

Secondary outcome [3]

Sensation using a validated assessment of tactile spatial resolution.

Timepoint [3]

Eligibility

Key inclusion criteria

* within 6 weeks of first stroke
* unilateral stroke
* impaired arm function
* able to cope with intensive training program
* medically stable
* able to understand instructions

Minimum age

18 Years

Maximum age

No limit

Sex

Both males and females

Can healthy volunteers participate?

Key exclusion criteria

* uncontrolled systemic disease
* significant musculotendinous or bony restrictions of the affected upper limb
* any serious chronic disease independently causing significant disability of the affected limb

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)

Methods used to generate the sequence in which subjects will be randomised (sequence generation)

Masking / blinding

Blinded (masking used)

Who is / are masked / blinded?

Intervention assignment

Parallel

Other design features

Phase

Not applicable

Type of endpoint/s

Statistical methods / analysis

Recruitment

Recruitment status

Completed

Data analysis

Reason for early stopping/withdrawal

Other reasons

Date of first participant enrolment

Anticipated

Actual

1/02/2002

Date of last participant enrolment

Anticipated

Actual

Date of last data collection

Anticipated

Actual

Sample size

Target

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

VIC

Recruitment hospital [1]

Austin Health - Melbourne

Recruitment postcode(s) [1]

3084 - Melbourne

Funding & Sponsors

Primary sponsor type

Other

Name

University of Melbourne

Address

Country

Ethics approval

Ethics application status

Summary

Brief summary

Stroke is the leading cause of long-term physical disability in Australia. Currently around 25% of hemiplegic stroke patients discharged from rehabilitation have significantly impaired use of the affected hand with consequent dependence in dressing, grooming and feeding themselves. The poor outcome can be attributed in part to a lack of focus by therapists on the negative signs of stroke (weakness and lack of dexterity) as well as too little time (around 10 minutes per day) being devoted to retraining of the arm. Presently there is a very limited evidence base to guide the content of clinical practice. Results from both animal and human studies suggest that specific post-lesion training can result in substantial improvement in function. The hypothesis is that task-specific training of the affected upper limb to subjects in the early period following stroke will result in significantly better functional outcome than standard intervention.

Trial website

https://clinicaltrials.gov/study/NCT00222339

Trial related presentations / publications

Miller K, Galea M, Kilbreath S, Phillips B (2002) Early intensive task-specific sensory and motor training of the upper limb following acute stroke: a pilot study. In Battistin L, Dam M, Tonin P(eds) Neurological Rehabilitation. Bologna:Mondizzi Editore.

Public notes

Contacts

Principal investigator

Name

Mary P Galea, PhD

Address

University of Melbourne

Country

Phone

Fax

Contact person for public queries

Name

Address

Country

Phone

Fax

Contact person for scientific queries

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

Type	Citations or Other Details
Journal	Miller K, Galea M, Kilbreath S, Phillips B (2002) ... [More Details]

Results not provided in https://clinicaltrials.gov/study/NCT00222339

Trial Review

Registering a new trial?

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00222339