Clinical trial NCT00167531: The Efficacy of Treadmill Training in Establishing Walking After Stroke
Official title: The Efficacy of Treadmill Training in Establishing Walking After Stroke
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Stroke
Keywords: Stroke
health outcomes
physiotherapy
rehabilitation
treadmill
Lead sponsor: University of Sydney
Sponsor class: OTHER
First posted: 2005-09-14
Enrollment: 126
Sex: ALL
Minimum age (years): 50
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: 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').
timeFrame: Within 6 months
Secondary outcomes:
measure: Quality of walking: measured by quantifying parameters such as speed, affected and intact step length, step width, and cadence during 10 m walk test.
timeFrame: Within 6 months
measure: Walking capacity at six months measured by 10 m and 6 minute walk tests. Walking participation measured using the Adelaide Activity Profile.
timeFrame: 6 months
Other outcomes:
Locations:
city: Sydney
country: Australia
facility: The Prince Henry and Prince of Wales Hospitals
state: New South Wales
city: Sydney
country: Australia
facility: Royal Rehabilitation Centre Sydney
state: New South Wales
city: Sydney
country: Australia
facility: Blacktown / Mt Druitt Hospital
state: New South Wales
city: Sydney
country: Australia
facility: St George Hospital
state: New South Wales
city: Melbourne
country: Australia
facility: Kingston Centre
state: Victoria
Study officials:
affiliation: University of Sydney
name: Louise Ada, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Sydney
name: Catherine Dean, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Melbourne
name: Meg Morris, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Sydney
name: Judy Simpson, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.