StrokePhase 2NCT00167531
The Efficacy of Treadmill Training in Establishing Walking After Stroke
A Phase 2 study testing treadmill walking with partial weight support and assisted overground walking in people with Stroke, run by University of Sydney at 5 sites in Australia.
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. Read more about this study
- Who is it for?
- Ages 50 to 85 years
- Conditions the study is for
- Stroke
- What is being tested?
- treadmill walking with partial weight support and assisted overground walking
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 126 participants
- Where
- 5 sitesAustralia
- Study dates
- Aug 2002to Jul 2009
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
Australia5 sites
Kingston Centre
Melbourne, Victoria, 3192
The Prince Henry and Prince of Wales Hospitals
Sydney, New South Wales, 2031
Royal Rehabilitation Centre Sydney
Sydney, New South Wales, 2112
Blacktown / Mt Druitt Hospital
Sydney, New South Wales, 2148
St George Hospital
Sydney, New South Wales, 2217
About this study
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.
Read the 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.
- Conditions
- Stroke
- Being tested
- treadmill walking with partial weight support, assisted overground walking
- Keywords
- Stroke, health outcomes, physiotherapy, rehabilitation, treadmill
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
treadmill walking with partial weight supportBehavioural
assisted overground walkingBehavioural
30 minutes per day of overground walking with the assistance of one therapist
| Study group | Role | What they receive |
|---|---|---|
| Treadmill walking | Experimental | 30 minutes per day of treadmill walking with body weight support and assistance from one therapist Receives: Behavioral: treadmill walking with partial weight support |
| Overground walking | Active comparator | 30 minutes per day of overground walking with assistance from one therapist Receives: Behavioral: assisted overground walking |
What is being measured
The primary outcome is the main question the study is designed to answer.
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').
Measured: Within 6 months
Secondary outcomes (2)
Quality of walking: measured by quantifying parameters such as speed, affected and intact step length, step width, and cadence during 10 m walk test.
Measured: 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.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2005 (estimated)
- Study startAug 2002
- Primary completionApr 2009
- Study completionJul 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Enrolment
- 126 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Sydney
- Sponsor type
- University, hospital or other
- Investigators
- Louise Ada, PhD, Principal investigator, University of SydneyCatherine Dean, PhD, Principal investigator, University of SydneyMeg Morris, PhD, Principal investigator, University of MelbourneJudy Simpson, PhD, Principal investigator, University of Sydney
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00167531
- Sponsor's protocol ID
- 02/06/09
- Status last verified
- Sep 2006
- First submitted
- 12 Sep 2005
- Last updated
- 2 Oct 2009
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 14586916Dean 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.
PubMed 20482476Ada 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.
PubMed 20413741Ada 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.
PubMed 17803825
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy of Treadmill Training in Establishing Walking After Stroke
- ClinicalTrials.gov ID
- NCT00167531
- Acronym / sponsor ID
- 02/06/09
- Conditions
- Stroke
- Keywords
- Stroke, health outcomes, physiotherapy, rehabilitation, treadmill
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 126 participants (actual)
- Lead sponsor
- University of SydneyUniversity, hospital or other
- Study start
- Aug 2002
- Primary completion
- Apr 2009 (actual)
- Study completion
- Jul 2009 (actual)
- First posted
- 14 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treadmill walking | Experimental | Behavioral: treadmill walking with partial weight support30 minutes per day of treadmill walking with body weight support and assistance from one therapist |
| Overground walking | Active comparator | Behavioral: assisted overground walking30 minutes per day of overground walking with assistance from one therapist |
Who may qualify
- Ages
- 50 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| treadmill walking with partial weight support | Behavioural | Treadmill walking |
| assisted overground walking30 minutes per day of overground walking with the assistance of one therapist | Behavioural | Overground walking |
Primary outcome
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
2 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2009.
- Background: PubMed 14586916Ada 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.
- Derived from this study: PubMed 20482476Dean 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.
- Derived from this study: PubMed 20413741Ada 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.
- Derived from this study: PubMed 17803825Ada 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Louise Ada, PhD principal investigator
University of Sydney
Catherine Dean, PhD principal investigator
University of Sydney
Meg Morris, PhD principal investigator
University of Melbourne
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing treadmill walking with partial weight support and assisted overground walking in people with Stroke, run by University of Sydney at 5 sites in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Oct 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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'). (time frame: Within 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00167531, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Oct 2009.