ANZCTR - Registration

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Trial registered on ANZCTR

Registration number

ACTRN12606000235505

Ethics application status

Approved

Date submitted

5/06/2006

Date registered

14/06/2006

Date last updated

26/09/2011

Type of registration

Retrospectively registered

Titles & IDs

Public title

Regaining the ability to walk outdoors following stroke: the efficacy of the Bobath concept compared to structured task practice.

Scientific title

Regaining the ability to walk outdoors following stroke: the efficacy of the Bobath concept compared to structured task practice.

Secondary ID [1]

Nil known

Universal Trial Number (UTN)

Trial acronym

Nil

Linked study record

Health condition

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

Stroke

Condition category

Condition code

Stroke

Ischaemic

Stroke

Haemorrhagic

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

A) Bobath Intervention - Intervention Group

Each group receives 6 x 1 hour treatment sessions within a 2 week period.

Therapists must have at least 5 years postgraduate experience and at least two years experience in the fields of rehabilitation or neurology. The therapsit providing Intervention A must have completed a Basic Bobath Course and at least two Advanced Bobath Courses.

During the intervention period the participant does not receive any other physiotherapy aimed at improving mobility, postur, balance or lower limb function.

Intervention code [1]

Rehabilitation

Comparator / control treatment

B) Structured task practice - Control Group

Control group

Active

Outcomes

Primary outcome [1]

Six minute walk test (modified)

Timepoint [1]

The test will be performed prior to commencement of the 6 treatment sessions and following completion of the 6 treatment sessions.

Secondary outcome [1]

Berg Balance Scale

Timepoint [1]

The test will be performed prior to commencement of the 6 treatment sessions and following completion of the 6 treatment sessions.

Secondary outcome [2]

Gait speed

Timepoint [2]

The test will be performed prior to commencement of the 6 treatment sessions and following completion of the 6 treatment sessions.

Secondary outcome [3]

Stair Climbing speed

Timepoint [3]

The test will be performed prior to commencement of the 6 treatment sessions and following completion of the 6 treatment sessions.

Eligibility

Key inclusion criteria

First or recurrent stroke diagnosis, haemorrhage or infarct. Between four weeks and sixteen weeks post stroke at commencement of trial. Currently participating in an inpatient or outpatient rehabilitation program. Able to walk 15 metres indoors on a level surface, with or without an aid, with supervision.

Minimum age

18 Years

Maximum age

Not stated

Sex

Both males and females

Can healthy volunteers participate?

Key exclusion criteria

Premorbid mobility limited to walking indoors only. Inability to follow single stage verbal commands with visual prompts sufficient to complete the required assessments. Able to walk safely outdoors without supervision. Mobility disability due primarily to pathologies other than stroke.

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)

Concealed evelopes

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

Computer randomisation

Masking / blinding

Blinded (masking used)

Who is / are masked / blinded?

Intervention assignment

Parallel

Other design features

Phase

Phase 1

Type of endpoint/s

Efficacy

Statistical methods / analysis

Recruitment

Recruitment status

Completed

Date of first participant enrolment

Anticipated

1/06/2005

Actual

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)

Funding & Sponsors

Funding source category [1]

Charities/Societies/Foundations

Name [1]

St Vincents Health Rsearch Grant

Address [1]

Victoria Parade Fitzroy 3065 Victoria

Country [1]

Australia

Primary sponsor type

Charities/Societies/Foundations

Name

St Vincents Health

Address

Victoria Parade Fitzroy 3065 Victoria

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

St Vincents Health

Ethics committee address [1]

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

Approval date [1]

25/05/2005

Ethics approval number [1]

6-05

Ethics committee name [2]

Goulburn Valley Health

Ethics committee address [2]

Ethics committee country [2]

Australia

Date submitted for ethics approval [2]

Approval date [2]

12/09/2005

Ethics approval number [2]

GVH - 04/05

Ethics committee name [3]

Kliniken Schmeider in Constanz

Ethics committee address [3]

Ethics committee country [3]

Germany

Date submitted for ethics approval [3]

Approval date [3]

Ethics approval number [3]

Summary

Brief summary

The purpose of this project is to investigate the effectiveness of physiotherapy treatment interventions aimed at improving ability to walk safely outdoors following stroke. This project is a pilot study that will compare the effectiveness of two physiotherapy interventions for regaining the ability to walk outdoors. The structured task practice is an evidence based approach focusing on repeated practice of the different tasks involved in walking outdoors, such as walking on slopes and crossing gutters. The alternative interventions are based on the Bobath Concept, a treatment approach that focuses on the development of postural stability to improve balance and walking function. Participants for the pilot study will be sought from patients who are currently undergoing rehabilitation (either inpatient or outpatient) following stroke and who have recently achieved the ability to walk with supervision indoors. Thirty participants will be recruited for the pilot study. Participants will have baseline assessments including the adapted six minute walk test, their walking velocity (over the central 6 metres of a 10 metre track), the time taken to ascend and descend a flight of stairs and scores on the Berg Balance Scale (an ordinal scale assessing ability to perform 14 balance tasks) by a blind assessor.  Participants will be randomised to either of the two interventions. Patients are blinded to which group they have been randomised.  Both interventions will require the participant to attend six one hour physiotherapy sessions over a two week period. In the structured task practice intervention, participants will practice activities such as walking on slopes, going up and down a single step, and walking on uneven ground. In the Bobath Concept intervention, the postural stability of the participant will be assessed and individualised treatment programs established, aimed at improving postural stability. These sessions will include activities in standing and walking to enhance standing balance, patterns of muscle activation and postural responses. The sessions will incorporate some task practice to a maximum of 1/6 of the treatment time. The baseline assessments will be repeated following the intervention stage.Analysis of the pilot data will enable accurate power calculations for a larger multi centre trial.

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Address

Country

Phone

Fax

Contact person for public queries

Name

Dr Kim Brock

Address

Physiotherapy Department
St Vincents Hospital
Victoria Pde
Fitzroy VIC 3065

Country

Australia

Phone

+61 3 92882211

Fax

kim.brock@svhm.org.au

Contact person for scientific queries

Name

Dr Kim Brock

Address

Physiotherapy Department
St Vincents Hospital
Victoria Pde
Fitzroy VIC 3065

Country

Australia

Phone

+61 3 92882211

Fax

kim.brock@svhm.org.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

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Documents added manually

Documents added automatically