The Efficacy of Treadmill Training in Establishing Walking After Stroke

October 1, 2009 updated by: University of Sydney

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

126

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

48 years to 83 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
Within 6 months

Secondary Outcome Measures

Outcome Measure
Time Frame
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
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
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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, University of Melbourne
  • Principal Investigator: Judy Simpson, PhD, University of Sydney

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2002

Primary Completion (Actual)

April 1, 2009

Study Completion (Actual)

July 1, 2009

Study Registration Dates

First Submitted

September 12, 2005

First Submitted That Met QC Criteria

September 12, 2005

First Posted (Estimate)

September 14, 2005

Study Record Updates

Last Update Posted (Estimate)

October 2, 2009

Last Update Submitted That Met QC Criteria

October 1, 2009

Last Verified

September 1, 2006

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 02/06/09

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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