The Efficacy of Treadmill Training in Establishing Walking After Stroke
1 other identifier
interventional
126
1 country
5
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 Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2 stroke
Started Aug 2002
Longer than P75 for phase_2 stroke
5 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2002
CompletedFirst Submitted
Initial submission to the registry
September 12, 2005
CompletedFirst Posted
Study publicly available on registry
September 14, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2009
CompletedOctober 2, 2009
September 1, 2006
6.7 years
September 12, 2005
October 1, 2009
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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').
Within 6 months
Secondary Outcomes (2)
Quality of walking: measured by quantifying parameters such as speed, affected and intact step length, step width, and cadence during 10 m walk test.
Within 6 months
Walking capacity at six months measured by 10 m and 6 minute walk tests. Walking participation measured using the Adelaide Activity Profile.
6 months
Study Arms (2)
Treadmill walking
EXPERIMENTAL30 minutes per day of treadmill walking with body weight support and assistance from one therapist
Overground walking
ACTIVE COMPARATOR30 minutes per day of overground walking with assistance from one therapist
Interventions
30 minutes per day of overground walking with the assistance of one therapist
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (5)
The Prince Henry and Prince of Wales Hospitals
Sydney, New South Wales, 2031, Australia
Royal Rehabilitation Centre Sydney
Sydney, New South Wales, 2112, Australia
Blacktown / Mt Druitt Hospital
Sydney, New South Wales, 2148, Australia
St George Hospital
Sydney, New South Wales, 2217, Australia
Kingston Centre
Melbourne, Victoria, 3192, Australia
Related Publications (4)
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.
PMID: 14586916BACKGROUNDDean 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.
PMID: 20482476DERIVEDAda 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.
PMID: 20413741DERIVEDAda 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.
PMID: 17803825DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Louise Ada, PhD
University of Sydney
- PRINCIPAL INVESTIGATOR
Catherine Dean, PhD
University of Sydney
- PRINCIPAL INVESTIGATOR
Meg Morris, PhD
University of Melbourne
- PRINCIPAL INVESTIGATOR
Judy Simpson, PhD
University of Sydney
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
September 12, 2005
First Posted
September 14, 2005
Study Start
August 1, 2002
Primary Completion
April 1, 2009
Study Completion
July 1, 2009
Last Updated
October 2, 2009
Record last verified: 2006-09