search
Back to results

The Efficacy of Treadmill Training in Establishing Walking After Stroke

Primary Purpose

Stroke

Status
Completed
Phase
Phase 2
Locations
Australia
Study Type
Interventional
Intervention
treadmill walking with partial weight support
assisted overground walking
Sponsored by
University of Sydney
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke focused on measuring Stroke, health outcomes, physiotherapy, rehabilitation, treadmill

Eligibility Criteria

50 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • The Prince Henry and Prince of Wales Hospitals
  • Royal Rehabilitation Centre Sydney
  • Blacktown / Mt Druitt Hospital
  • St George Hospital
  • Kingston Centre

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Treadmill walking

Overground walking

Arm Description

30 minutes per day of treadmill walking with body weight support and assistance from one therapist

30 minutes per day of overground walking with assistance from one therapist

Outcomes

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').

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.
Walking capacity at six months measured by 10 m and 6 minute walk tests. Walking participation measured using the Adelaide Activity Profile.

Full Information

First Posted
September 12, 2005
Last Updated
October 1, 2009
Sponsor
University of Sydney
search

1. Study Identification

Unique Protocol Identification Number
NCT00167531
Brief Title
The Efficacy of Treadmill Training in Establishing Walking After Stroke
Official Title
The Efficacy of Treadmill Training in Establishing Walking After Stroke
Study Type
Interventional

2. Study Status

Record Verification Date
September 2006
Overall Recruitment Status
Completed
Study Start Date
August 2002 (undefined)
Primary Completion Date
April 2009 (Actual)
Study Completion Date
July 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
University of Sydney

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke
Keywords
Stroke, health outcomes, physiotherapy, rehabilitation, treadmill

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Single
Allocation
Randomized
Enrollment
126 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Treadmill walking
Arm Type
Experimental
Arm Description
30 minutes per day of treadmill walking with body weight support and assistance from one therapist
Arm Title
Overground walking
Arm Type
Active Comparator
Arm Description
30 minutes per day of overground walking with assistance from one therapist
Intervention Type
Behavioral
Intervention Name(s)
treadmill walking with partial weight support
Intervention Type
Behavioral
Intervention Name(s)
assisted overground walking
Intervention Description
30 minutes per day of overground walking with the assistance of one therapist
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
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
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Louise Ada, PhD
Organizational Affiliation
University of Sydney
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Catherine Dean, PhD
Organizational Affiliation
University of Sydney
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Meg Morris, PhD
Organizational Affiliation
University of Melbourne
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Judy Simpson, PhD
Organizational Affiliation
University of Sydney
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Prince Henry and Prince of Wales Hospitals
City
Sydney
State/Province
New South Wales
ZIP/Postal Code
2031
Country
Australia
Facility Name
Royal Rehabilitation Centre Sydney
City
Sydney
State/Province
New South Wales
ZIP/Postal Code
2112
Country
Australia
Facility Name
Blacktown / Mt Druitt Hospital
City
Sydney
State/Province
New South Wales
ZIP/Postal Code
2148
Country
Australia
Facility Name
St George Hospital
City
Sydney
State/Province
New South Wales
ZIP/Postal Code
2217
Country
Australia
Facility Name
Kingston Centre
City
Melbourne
State/Province
Victoria
ZIP/Postal Code
3192
Country
Australia

12. IPD Sharing Statement

Citations:
PubMed Identifier
14586916
Citation
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.
Results Reference
background
PubMed Identifier
20482476
Citation
Dean 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.
Results Reference
derived
PubMed Identifier
20413741
Citation
Ada 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.
Results Reference
derived
PubMed Identifier
17803825
Citation
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. doi: 10.1186/1471-2377-7-29.
Results Reference
derived

Learn more about this trial

The Efficacy of Treadmill Training in Establishing Walking After Stroke

We'll reach out to this number within 24 hrs