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
  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 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind
Primary Purpose: Treatment
Official Title: The Efficacy of Treadmill Training in Establishing Walking After Stroke

Resource links provided by NLM:


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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00167531     History of Changes
Other Study ID Numbers: 02/06/09
Study First Received: September 12, 2005
Last Updated: October 1, 2009
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:
Stroke
Cerebral Infarction
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Brain Infarction
Brain Ischemia

ClinicalTrials.gov processed this record on August 19, 2014