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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treadmill walking | Experimental | 30 minutes per day of treadmill walking with body weight support and assistance from one therapist |
|
| Overground walking | Active Comparator | 30 minutes per day of overground walking with assistance from one therapist |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| treadmill walking with partial weight support | Behavioral |
| ||
| assisted overground walking |
| 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 |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| 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 | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Prince Henry and Prince of Wales Hospitals | Sydney | New South Wales | 2031 | Australia | ||
| Royal Rehabilitation Centre Sydney |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 14586916 | Background | 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. doi: 10.1016/s0003-9993(03)00349-6. | |
| 20482476 | Derived | Dean CM, Ada L, Bampton J, Morris ME, Katrak PH, Potts S. Treadmill walking with body weight support in subacute non-ambulatory stroke improves walking capacity more than overground walking: a randomised trial. J Physiother. 2010;56(2):97-103. doi: 10.1016/s1836-9553(10)70039-4. |
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| ID | Term |
|---|---|
| D020521 | Stroke |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| Behavioral |
30 minutes per day of overground walking with the assistance of one therapist |
|
| 6 months |
| Sydney |
| New South Wales |
| 2112 |
| Australia |
| Blacktown / Mt Druitt Hospital | Sydney | New South Wales | 2148 | Australia |
| St George Hospital | Sydney | New South Wales | 2217 | Australia |
| Kingston Centre | Melbourne | Victoria | 3192 | Australia |
| 20413741 | Derived | Ada L, Dean CM, Morris ME, Simpson JM, Katrak P. Randomized trial of treadmill walking with body weight support to establish walking in subacute stroke: the MOBILISE trial. Stroke. 2010 Jun;41(6):1237-42. doi: 10.1161/STROKEAHA.109.569483. Epub 2010 Apr 22. |
| 17803825 | Derived | Ada L, Dean CM, Morris ME. Supported treadmill training to establish walking in non-ambulatory patients early after stroke. BMC Neurol. 2007 Sep 6;7:29. doi: 10.1186/1471-2377-7-29. |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |