A Phase 2 interventional study of treadmill walking with partial weight support and assisted overground walking in Stroke, sponsored by University of Sydney. Completed at 5 sites in Australia. Open to participants aged 50 Years to 85 Years. Per ClinicalTrials.gov, last updated 2009-10-02.
Sponsored by University of Sydney · Phase 2, Interventional, and Treatment
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.
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.
7,286 studies on the registry are indexed under Stroke; 2,007 are open to participants now.
This study's enrollment of 126 is above the median of 50 across 5,369 interventional studies indexed under Stroke.
Browse Stroke studies →University of Sydney is the lead sponsor of 91 studies on the registry; 25 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
30 minutes per day of treadmill walking with body weight support and assistance from one therapist
Behavioral: treadmill walking with partial weight support
30 minutes per day of overground walking with assistance from one therapist
Behavioral: assisted overground walking
30 minutes per day of overground walking with the assistance of one therapist
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
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
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
This study is completed, as verified in Sep 2006. You cannot join it, but the record below documents what was studied.
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University of Sydney