The Efficacy of Treadmill Training in Establishing Walking After Stroke

Stroke Clinical Trial

Official title:

The Efficacy of Treadmill Training in Establishing Walking After Stroke

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00167531
• Other study ID #: 02/06/09
• Status: Completed
• Phase: Phase 2
• First received: September 12, 2005
• Last updated: October 1, 2009
• Start date: August 2002
• Est. completion date: July 2009

Study information

• Verified date: September 2006
• Source: University of Sydney
• Contact: n/a
• Is FDA regulated: No
• Health authority: Australia: Department of Health and Ageing Therapeutic Goods Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 126
• Est. completion date: July 2009
• Est. primary completion date: April 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 50 Years to 85 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Stroke

Intervention

Behavioral:
• treadmill walking with partial weight support

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

Locations

Country	Name	City	State
Australia	Kingston Centre	Melbourne	Victoria
Australia	Blacktown / Mt Druitt Hospital	Sydney	New South Wales
Australia	Royal Rehabilitation Centre Sydney	Sydney	New South Wales
Australia	St George Hospital	Sydney	New South Wales
Australia	The Prince Henry and Prince of Wales Hospitals	Sydney	New South Wales

Sponsors (1)

Lead Sponsor	Collaborator
University of Sydney

Country where clinical trial is conducted

Australia, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Walking capacity at six months measured by 10 m and 6 minute walk tests. Walking participation measured using the Adelaide Activity Profile.		6 months