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Completed

NCT Number: NCT00167531

The Efficacy of Treadmill Training in Establishing Walking After Stroke

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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Key information

Conditions

Stroke Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Nervous System Diseases Vascular Diseases

Age range

50 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Blacktown / Mt Druitt Hospital, Sydney, New South Wales, Australia

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

treadmill walking with partial weight support

Behavioral

assisted overground walking

Behavioral

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

Primary outcomes

  1. 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 outcomes

  1. 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

  2. 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

Sponsors and collaborators

Lead sponsor

University of Sydney

Other

Registry information

Important dates

Study start
2002
Primary completion
2009
Study completion
2009
First posted
Sep 14, 2005
Registry last updated
Oct 2, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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