Trial Review

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 details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00167531




Registration number
NCT00167531
Ethics application status
Date submitted
12/09/2005
Date registered
14/09/2005
Date last updated
2/10/2009

Titles & IDs
Public title
The Efficacy of Treadmill Training in Establishing Walking After Stroke
Scientific title
The Efficacy of Treadmill Training in Establishing Walking After Stroke
Secondary ID [1] 0 0
02/06/09
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Stroke 0 0
Condition category
Condition code
Stroke 0 0 0 0
Haemorrhagic
Stroke 0 0 0 0
Ischaemic

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
BEHAVIORAL - assisted overground walking

Experimental: Treadmill walking - 30 minutes per day of treadmill walking with body weight support and assistance from one therapist

Active comparator: Overground walking - 30 minutes per day of overground walking with assistance from one therapist


BEHAVIORAL: assisted overground walking
30 minutes per day of overground walking with the assistance of one therapist
Intervention code [1] 0 0
BEHAVIORAL
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Proportion of participants walking independently (defined for the purposes of this study as'being able to walk 15 m continuously across flat ground without any aids').
Timepoint [1] 0 0
Within 6 months
Secondary outcome [1] 0 0
Quality of walking: measured by quantifying parameters such as speed, affected and intact step length, step width, and cadence during 10 m walk test.
Timepoint [1] 0 0
Within 6 months
Secondary outcome [2] 0 0
Walking capacity at six months measured by 10 m and 6 minute walk tests. Walking participation measured using the Adelaide Activity Profile.
Timepoint [2] 0 0
6 months

Eligibility
Key inclusion criteria
* First stroke
* Within 28 days post stroke
* Aged between 50 and 85 years of age
* Unilateral hemiplegia/hemiparesis and
* Score for Item 5 of the Motor Assessment Scale for Stroke < 2
Minimum age
50 Years
Maximum age
85 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Any barriers to taking part in a physical rehabilitation program
* Insufficient cognition/language
* Unstable cardiac status
* Neuro-surgery
* Any pre-morbid history of orthopaedic conditions or any other problems that would preclude patient from relearning to walk.

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
Phase 2
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
1/08/2002
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/07/2009
Sample size
Target
Accrual to date
Final
126
Recruitment in Australia
Recruitment state(s)
NSW,VIC
Recruitment hospital [1] 0 0
The Prince Henry and Prince of Wales Hospitals - Sydney
Recruitment hospital [2] 0 0
Royal Rehabilitation Centre Sydney - Sydney
Recruitment hospital [3] 0 0
Blacktown / Mt Druitt Hospital - Sydney
Recruitment hospital [4] 0 0
St George Hospital - Sydney
Recruitment hospital [5] 0 0
Kingston Centre - Melbourne
Recruitment postcode(s) [1] 0 0
2031 - Sydney
Recruitment postcode(s) [2] 0 0
2112 - Sydney
Recruitment postcode(s) [3] 0 0
2148 - Sydney
Recruitment postcode(s) [4] 0 0
2217 - Sydney
Recruitment postcode(s) [5] 0 0
3192 - Melbourne

Funding & Sponsors
Primary sponsor type
Other
Name
University of Sydney
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Being able to walk is a major determinant of whether a patient returns home after stroke or lives in residential care. For the family, the loss of the stroke sufferer from everyday life is a catastrophic event. For the community, the costs of being unable to walk after stroke are exorbitant, involving a lifetime of residential care. Therefore, an increase in the proportion of stroke patients who regain walking ability will be a significant advance.

This trial will determine, in patients early after stroke who are unable to walk, whether training walking using a treadmill with partial weight support via an overhead harness will be more effective than current intervention in (i) establishing more independent walking, reducing the time taken to achieve independent walking, and improving the quality of independent walking, and (ii) improving walking capacity and participation 6 months later.
Trial website
https://clinicaltrials.gov/study/NCT00167531
Trial related presentations / publications
Ada L, Dean CM, Hall JM, Bampton J, Crompton S. A treadmill and overground walking program improves walking in persons residing in the community after stroke: a placebo-controlled, randomized trial. Arch Phys Med Rehabil. 2003 Oct;84(10):1486-91. doi: 10.1016/s0003-9993(03)00349-6.
Dean CM, Ada L, Bampton J, Morris ME, Katrak PH, Potts S. Treadmill walking with body weight support in subacute non-ambulatory stroke improves walking capacity more than overground walking: a randomised trial. J Physiother. 2010;56(2):97-103. doi: 10.1016/s1836-9553(10)70039-4.
Ada L, Dean CM, Morris ME, Simpson JM, Katrak P. Randomized trial of treadmill walking with body weight support to establish walking in subacute stroke: the MOBILISE trial. Stroke. 2010 Jun;41(6):1237-42. doi: 10.1161/STROKEAHA.109.569483. Epub 2010 Apr 22.
Ada L, Dean CM, Morris ME. Supported treadmill training to establish walking in non-ambulatory patients early after stroke. BMC Neurol. 2007 Sep 6;7:29. doi: 10.1186/1471-2377-7-29.
Public notes

Contacts
Principal investigator
Name 0 0
Louise Ada, PhD
Address 0 0
University of Sydney
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT00167531