The Efficacy of Treadmill Training in Establishing Walking After Stroke

Study Overview
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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.

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.

Official Title
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The Efficacy of Treadmill Training in Establishing Walking After Stroke

Conditions
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Stroke

Intervention / Treatment
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* Behavioral: treadmill walking with partial weight support
* Behavioral: assisted overground walking


Participation Criteria
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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.

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treadmill walking<br>30 minutes per day of treadmill walking with body weight support and assistance from one therapist | Behavioral: treadmill walking with partial weight support<br> <br> |
| Active Comparator: Overground walking<br>30 minutes per day of overground walking with assistance from one therapist | Behavioral: assisted overground walking<br>* 30 minutes per day of overground walking with the assistance of one therapist<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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'). |  | Within 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | 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. |  | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Stroke, health outcomes, physiotherapy, rehabilitation, treadmill