The Efficacy of Treadmill Training in Establishing Walking After Stroke
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|ClinicalTrials.gov Identifier: NCT00167531|
Recruitment Status : Completed
First Posted : September 14, 2005
Last Update Posted : October 2, 2009
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.
|Condition or disease||Intervention/treatment||Phase|
|Stroke||Behavioral: treadmill walking with partial weight support Behavioral: assisted overground walking||Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||126 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||The Efficacy of Treadmill Training in Establishing Walking After Stroke|
|Study Start Date :||August 2002|
|Actual Primary Completion Date :||April 2009|
|Actual Study Completion Date :||July 2009|
Experimental: Treadmill walking
30 minutes per day of treadmill walking with body weight support and assistance from one therapist
|Behavioral: treadmill walking with partial weight support|
Active Comparator: Overground walking
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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00167531
|Australia, New South Wales|
|The Prince Henry and Prince of Wales Hospitals|
|Sydney, New South Wales, Australia, 2031|
|Royal Rehabilitation Centre Sydney|
|Sydney, New South Wales, Australia, 2112|
|Blacktown / Mt Druitt Hospital|
|Sydney, New South Wales, Australia, 2148|
|St George Hospital|
|Sydney, New South Wales, Australia, 2217|
|Melbourne, Victoria, Australia, 3192|
|Principal Investigator:||Louise Ada, PhD||University of Sydney|
|Principal Investigator:||Catherine Dean, PhD||University of Sydney|
|Principal Investigator:||Meg Morris, PhD||University of Melbourne|
|Principal Investigator:||Judy Simpson, PhD||University of Sydney|