Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12607000412437
Ethics application status
Approved
Date submitted
16/05/2007
Date registered
13/08/2007
Date last updated
5/06/2009
Type of registration
Retrospectively registered

Titles & IDs
Public title
Treadmill walking to improve walking and fitness following stroke: a single blinded pilot randomised controlled trial.
Scientific title
In stroke patients undergoing rehabilitation does treadmill walking compared to usual physiotherapy gait retraining improve walking and cardiorespiratory fitness.
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
People with stroke 2246 0
Condition category
Condition code
Stroke 2276 2276 0 0
Ischaemic
Neurological 2337 2337 0 0
Other neurological disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treadmill walking - 30 minute sessions, 3 times a week for 6 weeks. Total dose of treadmill walking 9 hours. Participants will receive usual physiotherapy and rehabilitation during this time.
Intervention code [1] 1958 0
Rehabilitation
Comparator / control treatment
Will continue to recieve usual physiotherapy gait retraining program based on motor relearnig principles but will involve no treadmill walking.
Control group
Active

Outcomes
Primary outcome [1] 3162 0
Walking capacity as measured by distance walked in 6 minutes
Timepoint [1] 3162 0
For all measures is at baseline, at end of 6 week intervention and 3 months following completion of intervention period.
Primary outcome [2] 3163 0
Spatial temporal gait variables of walking speed, usual and fast measured by GAITRite.
Timepoint [2] 3163 0
For all measures is at baseline, at end of 6 week intervention and 3 months following completion of intervention period.
Primary outcome [3] 3164 0
Joint angles during overground walking
Timepoint [3] 3164 0
For all measures is at baseline, at end of 6 week intervention and 3 months following completion of intervention period.
Secondary outcome [1] 5278 0
6 minute walk test distance
Timepoint [1] 5278 0
All measures are at baseline, at end of 6 week intervention and 3 months following completion of intervention.
Secondary outcome [2] 5279 0
peak oxygen uptake during 6 minute walk test.
Timepoint [2] 5279 0
All measures are at baseline, at end of 6 week intervention and 3 months following completion of intervention.
Secondary outcome [3] 242310 0
Walking quality as measured by Visual analogue scale.
Timepoint [3] 242310 0
all measures will be recorded at baseline, at end of 6 week intervention and 3 months following completion of intervention

Eligibility
Key inclusion criteria
Diagnosis of stroke
Medically stable
Able to walk independently prior to stroke
Are referred for physiotherapy
Have gait deficits on initial assessment
Have sufficient cognition and communication to understand the purpose of the study and give informed consent or mini mental state exam >22
Attain a score of at least 3 on Motor Assessment Scale, Walking
Able to walk on the treadmill with or without assistance of 1 person
Minimum age
No limit
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Have any other neurological conditions that may influence their gait (eg. PD, MS)
Have major musculoskeletal disorders that may influence their gait (eg. amputation, fracture, THR)
Have any uncompensated sensory dysfunction that may affect their gait (e.g. blindness)
Have any cardiovascular problems that would limit their participation in physiotherapy

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)
Principal investigator will peruse admission list to identify potential participants.Regular contact will be made with treating physiotherapists. Once potential participant is identified, medical clearance will be sought from treating consultant. All potential participants will undergo assessment to ensure suitablility. Once approval gained and participant consented, assessment by a blinded assessor will be arranged. Following assessment, subjects will be randomised. Allocation will be concealed through the use of consecutively numbered opaque sealed envelopes and will be maintained at a central location.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Off site investigator using computer generated random number program will randomise subjects into experimental and controlled groups.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Factorial
Other design features
Assessors will be blinded.
Phase
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
2/07/2007
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
30
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 2441 0
Hospital
Name [1] 2441 0
Princess Alexandra Hospital
Country [1] 2441 0
Australia
Funding source category [2] 2442 0
University
Name [2] 2442 0
University of Queensland
Country [2] 2442 0
Australia
Funding source category [3] 2496 0
Hospital
Name [3] 2496 0
Princess Alexandra Hospital
Country [3] 2496 0
Australia
Funding source category [4] 3611 0
Self funded/Unfunded
Name [4] 3611 0
Country [4] 3611 0
Australia
Primary sponsor type
Hospital
Name
Princess Alexandra Hospital
Address
Ipswich Road
Wooloongabba Qld 4102
Country
Australia
Secondary sponsor category [1] 2213 0
University
Name [1] 2213 0
Griffith University
Address [1] 2213 0
Gold Coast Campus, PMB 50, Gold Coast 9726
Country [1] 2213 0
Australia
Secondary sponsor category [2] 2269 0
University
Name [2] 2269 0
University of Queensland
Address [2] 2269 0
School of Health and Rehabilitation Sciences
University of Queensland
St Lucia 4072
Country [2] 2269 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 4291 0
Princess Alexandra Hospital
Ethics committee address [1] 4291 0
Ipswich Road, Woollongabba
Ethics committee country [1] 4291 0
Australia
Date submitted for ethics approval [1] 4291 0
Approval date [1] 4291 0
01/09/2007
Ethics approval number [1] 4291 0
Ethics committee name [2] 4292 0
University of Queensland
Ethics committee address [2] 4292 0
St Lucia 4072
Ethics committee country [2] 4292 0
Australia
Date submitted for ethics approval [2] 4292 0
Approval date [2] 4292 0
01/09/2007
Ethics approval number [2] 4292 0
Ethics committee name [3] 4405 0
Ethics committee address [3] 4405 0
Ethics committee country [3] 4405 0
Date submitted for ethics approval [3] 4405 0
16/05/2007
Approval date [3] 4405 0
Ethics approval number [3] 4405 0
2007/097

Summary
Brief summary
Following stroke few survivors regain full walking ability as impaired balance;
slower walking speed and poor cardiorespiratory fitness are frequently evident by
rehabilitation end. Treadmills have been used to improve walking in acute stroke
patients and fitness in chronic stroke patients. There are no published studies
investigating if treadmill walking can improve walking and fitness simultaneously.
This single-blind randomised controlled trial will examine the effectiveness of a
treadmill-walking program with specific heart rate targets to improve walking
following stroke. If effective this intervention has the potential to improve
independence and mobility following stroke thus reducing the burden of care in the
community. This study will establish effectiveness to support a future larger trial.
The aim of this project is to investigate in people with a stroke who are able to
walk, does participation in a 6-week treadmill walking program with specific target
heart rates:
i. improve gait performance and cardiorespiratory fitness without compromising gait quality?
ii. result in gains that are maintained 3 months later?
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 27864 0
Address 27864 0
Country 27864 0
Phone 27864 0
Fax 27864 0
Email 27864 0
Contact person for public queries
Name 10950 0
Suzanne Kuys
Address 10950 0
Physiotherapy Department
Princess Alexandra Hospital
Ipswich Road
Woolloongabba QLD 4102
Country 10950 0
Australia
Phone 10950 0
07 32402401
Fax 10950 0
Email 10950 0
suzanne_kuys@health.qld.gov.au
Contact person for scientific queries
Name 1878 0
Suzanne Kuys
Address 1878 0
Physiotherapy Department
Princess Alexandra Hospital
Ipswich Road
Woolloongabba QLD 4102
Country 1878 0
Australia
Phone 1878 0
07 32402401
Fax 1878 0
Email 1878 0
suzanne_kuys@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

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