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The Efficacy of Treadmill Training in Establishing Walking After Stroke

This study has been completed.
Sponsor:
Information provided by:
University of Sydney
ClinicalTrials.gov Identifier:
NCT00167531
First received: September 12, 2005
Last updated: October 1, 2009
Last verified: September 2006
History of Changes

September 12, 2005
October 1, 2009
August 2002
April 2009   (final data collection date for primary outcome measure)
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 ]
*Achievement of independent walking (defined for the purposes of this study as‘being able to walk 15 m continuously across flat ground without any aids’).
Complete list of historical versions of study NCT00167531 on ClinicalTrials.gov Archive Site
  • 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 ]
  • *Quality of walking: measured by quantifying parameters such as speed, affected and intact step length, step width, and cadence during 10 m walk test.
  • * Walking capacity at six months measured by 10 m and 6 minute walk tests and self efficacy questionnaire.
Not Provided
Not Provided
 
The Efficacy of Treadmill Training in Establishing Walking After Stroke
The Efficacy of Treadmill Training in Establishing Walking After Stroke

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.

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.
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind
Primary Purpose: Treatment
Stroke
  • Behavioral: treadmill walking with partial weight support
  • Behavioral: assisted overground walking
    30 minutes per day of overground walking with the assistance of one therapist
  • Experimental: Treadmill walking
    30 minutes per day of treadmill walking with body weight support and assistance from one therapist
    Intervention: Behavioral: treadmill walking with partial weight support
  • Active Comparator: Overground walking
    30 minutes per day of overground walking with assistance from one therapist
    Intervention: Behavioral: assisted overground walking

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
126
July 2009
April 2009   (final data collection date for primary outcome measure)

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.
Both
50 Years to 85 Years
No
Contact information is only displayed when the study is recruiting subjects
Australia
 
NCT00167531
02/06/09
No
Not Provided
University of Sydney
Not Provided
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
University of Sydney
September 2006

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP