The Efficacy of Treadmill Training in Establishing Walking After Stroke

Phase 2

Completed

• Conditions: Stroke
• Interventions: Behavioral: treadmill walking with partial weight support; Behavioral: assisted overground walking

• Registration Number: NCT00167531
• Lead Sponsor: University of Sydney

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.

Study Timeline

• Study Start: 2002-08
• Study First Submitted: 2005-09-12
• Study First Submitted QC: 2005-09-12
• Study First Posted: 2005-09-14
• Status Verified: 2006-09
• Primary Completion: 2009-04
• Study Completion: 2009-07
• Last Update Submitted: 2009-10-01
• Last Update Posted: 2009-10-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 126

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Treadmill walking	treadmill walking with partial weight support	30 minutes per day of treadmill walking with body weight support and assistance from one therapist
Overground walking	assisted overground walking	30 minutes per day of overground walking with assistance from one therapist

Primary Outcome Measures

Name	Time	Method
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').	Within 6 months

Secondary Outcome Measures

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

Trial Locations

Locations (5)

Kingston Centre; 🇦🇺 Melbourne, Victoria, Australia

The Prince Henry and Prince of Wales Hospitals; 🇦🇺 Sydney, New South Wales, Australia

Royal Rehabilitation Centre Sydney; 🇦🇺 Sydney, New South Wales, Australia

Blacktown / Mt Druitt Hospital; 🇦🇺 Sydney, New South Wales, Australia

St George Hospital; 🇦🇺 Sydney, New South Wales, Australia