The Efficacy of Treadmill Training in Establishing Walking After Stroke - Full Text View

Sponsor:	University of Sydney
Information provided by:	University of Sydney
ClinicalTrials.gov Identifier:	NCT00167531

Purpose

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.

Condition	Intervention	Phase
Stroke	Behavioral: treadmill walking with partial weight support Behavioral: assisted overground walking	Phase II

Study Type:	Interventional
Study Design:	Treatment, Randomized, Single Blind, Active Control, Parallel Assignment, Efficacy Study
Official Title:	The Efficacy of Treadmill Training in Establishing Walking After Stroke

Resource links provided by NLM:

MedlinePlus related topics: Rehabilitation

U.S. FDA Resources

Further study details as provided by University of Sydney:

Primary Outcome Measures:

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'). [ Time Frame: Within 6 months ]

Secondary Outcome Measures:

Quality of walking: measured by quantifying parameters such as speed, affected and intact step length, step width, and cadence during 10 m walk test. [ Time Frame: 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. [ Time Frame: 6 months ]

Enrollment:	126
Study Start Date:	August 2002
Study Completion Date:	July 2009
Primary Completion Date:	April 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Treadmill walking: Experimental 30 minutes per day of treadmill walking with body weight support and assistance from one therapist	Behavioral: treadmill walking with partial weight support
Overground walking: Active Comparator 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

Detailed Description:

Only half of the stroke patients unable to walk who are admitted to inpatient rehabilitation in Australia learn to walk again. Treadmill training with partial weight support is a relatively new intervention that is designed to train walking. However, a Cochrane Systematic Review (Moseley et al 2003) concludes that there is as yet no definitive answer about whether this intervention helps more non-ambulatory patients learn to walk compared to assisted overground walking.

Participants will be 130 stroke patients who are unable to walk independently early after stroke. They will be recruited and randomly allocated to a control group or an experimental group.

The control group will undertake routine assisted overground walking training while the experimental group will undertake treadmill walking with partial weight support via an overhead harness. Duration and frequency of intervention and the amount of assistance from therapists will be standardised across groups.

Eligibility

Ages Eligible for Study:	50 Years to 85 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00167531

Locations

Australia, New South Wales
The Prince Henry and Prince of Wales Hospitals
Sydney, New South Wales, Australia, 2031
St George Hospital
Sydney, New South Wales, Australia, 2217
Royal Rehabilitation Centre Sydney
Sydney, New South Wales, Australia, 2112
Blacktown / Mt Druitt Hospital
Sydney, New South Wales, Australia, 2148
Australia, Victoria
Kingston Centre
Melbourne, Victoria, Australia, 3192

Sponsors and Collaborators

University of Sydney

Investigators

Principal Investigator:	Louise Ada, PhD	University of Sydney
Principal Investigator:	Catherine Dean, PhD	University of Sydney
Principal Investigator:	Meg Morris, PhD	The University of Melbourne
Principal Investigator:	Judy Simpson, PhD	University of Sydney

More Information

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.

Additional publications automatically indexed to this study by National Clinical Trials Identifier (NCT ID):

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.

Study ID Numbers:	02/06/09
Study First Received:	September 12, 2005
Last Updated:	October 1, 2009
ClinicalTrials.gov Identifier:	NCT00167531 History of Changes
Health Authority:	Australia: Department of Health and Ageing Therapeutic Goods Administration

Keywords provided by University of Sydney:

Stroke
health outcomes
physiotherapy
rehabilitation
treadmill

Additional relevant MeSH terms:

Cerebral Infarction
Nervous System Diseases
Stroke
Vascular Diseases
Brain Ischemia

Central Nervous System Diseases
Cardiovascular Diseases
Brain Infarction
Brain Diseases
Cerebrovascular Disorders

ClinicalTrials.gov processed this record on November 30, 2009