The Efficacy of Treadmill Training in Establishing Walking After Stroke

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

126 participants

Study Classification

INTERVENTIONAL

Study Start Date

2002-08-31

Study Completion Date

2009-07-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Stroke

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Study Groups

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Treadmill walking

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

Group Type EXPERIMENTAL

treadmill walking with partial weight support

Intervention Type BEHAVIORAL

Overground walking

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

Group Type ACTIVE_COMPARATOR

assisted overground walking

Intervention Type BEHAVIORAL

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

Interventions

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treadmill walking with partial weight support

Intervention Type BEHAVIORAL

assisted overground walking

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

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.

Minimum Eligible Age

50 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No