StrokePhase 2/3NCT00108030
PBWST (Partial Body-Weight Supported Treadmill Training) and Muscle Power Training After Sub-acute Stroke
A Phase 2/3 study testing Partial Body-weight supported Treadmill Training, PBWST + Power training and "Usual" physiotherapy care in people with Stroke, run by University of Sydney at 3 sites in Australia.
Trial summary
The specific aim of this project is to improve walking ability in persons following stroke using 'treadmill training plus power training'. This modality addresses the two major impairments followings stroke: weakness and incoordination, as well as loss of fitness. Read more about this study
- Who is it for?
- Ages 45 to 80 years
- Conditions the study is for
- Stroke
- What is being tested?
- Partial Body-weight supported Treadmill Training, PBWST + Power training and "Usual" physiotherapy care
- Type of treatment
- Surgery or procedure
- How many people
- 102 participants
- Where
- 3 sitesAustralia
- Study dates
- Mar 2004to Dec 2006
- Phase
- Phase 2/3
- 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 45 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- First stroke resulting in hemiplegia;
- Mini-Mental State Exam score > 15;
- Distance walked in 6-min walk test is less than the lower limit of 'normal' according to reference equations for healthy adults (adjusted for gender, age, BMI [Body Mass Index])
- Score on walking subscale of the Motor Assessment Scale of ≥ 2.
Who cannot join
- Unstable cardiac disease,
- Known un-repaired aortic or cerebral aneurysm
- Hemorrhagic stroke, symptomatic hernias, symptom limiting peripheral vascular disease,
- End-stage congestive cardiac failure,
- Any of the exclusion criteria contraindicating moderate exercise as outlined by American College of Sports Medicine guidelines for cardiac disease rehabilitation or for frail and elderly adults.
- Significant musculotendinous or bony restrictions of either limb,
- Any serious chronic disease independently causing significant disability or profound atrophy of the affected limb will comprise further exclusion criteria.
Trial locations and contacts
3 sites in 1 country.
Australia3 sites
Rehabilitation Research Centre, University of Sydney
Sydney, New South Wales, 2141
School of Physiotherapy, University of Sydney
Sydney, New South Wales, 2141
Coorabel Brain Injury Unit, Royal Rehabilitation Centre Sydney
Sydney, New South Wales
About this study
Official title: A RCT of Power Training and Treadmill Training to Improve Walking Ability in Sub-acute Stroke Patients
The specific aim of this project is to improve walking ability in persons following stroke using 'treadmill training plus power training'. This modality addresses the two major impairments followings stroke: weakness and incoordination, as well as loss of fitness. Importantly, this training will be presented at higher intensity and greater volume than is currently received. Furthermore, to ensure that persons continue to maintain the level of improvement from an intensive exercise program, we will also implement a behavioral change for long-term maintenance of exercise behavior in a less supervised environment. A randomized controlled clinical trial will be conducted in 102 sub-acute stroke patients to ascertain the efficacy of this approach to improving walking ability.
Hypotheses:
- Walking endurance will be increased to a greater degree in a patient group receiving treadmill plus muscle power training compared with a treadmill training only group, or 'usual care' group.
- Gait stability, muscle function, aerobic fitness and balance will improve more in a group receiving treadmill plus muscle power training, than either those in treadmill training or usual care patient groups.
- Habitual activity levels will be higher in the group receiving treadmill plus muscle power training compared with a treadmill training only group or 'usual care' group.
- The change in 6-minute walk distance will be positively related to changes in muscle power, strength and endurance, aerobic fitness, gait mechanics, and balance.
- Baseline depression and low self-efficacy will be associated with less robust adaptations to all types of training and lower rates of long-term compliance to the exercise prescription in the experimental groups.
Read the detailed description
To determine treatment efficacy, a single blinded, randomized controlled trial will be conducted. One hundred and two subjects will be randomly allocated to one of three groups comprising: (i) "Treadmill training + Power training" (TT+POWER), (ii) "Treadmill training" (TT), or (iii) "Usual Care" (USUAL). Those in the TT+POWER and TT will also receive 'usual care'. Subjects will be recruited within a week or two following their stroke, at which time they would be expected to be medically stable. Subjects in the training groups will attend training for 10 weeks, 3 times per week. Following the ten-week training program, subjects will be given a home-based training package to follow for 6 months.
Interventions:
Treadmill Training: The emphasis of the weight-supported treadmill training program will be initially to emphasize walking alignment. The amount of support will be reduced as quickly as possible to attain full weight-bearing on the motorized treadmill. Once a subject has attained full weight-bearing with correct segmental alignment, the emphasis will be on improving aerobic fitness whilst maintaining proper walking alignment.
Treadmill Training + Power Training: Subjects will undertake 30 min treadmill training, as described above, followed by 30 min of power training using pneumatic resistance equipment (Keiser Sports Health, Inc., Fresco, CA, USA) (leg press, knee extension and flexion, hip abduction, and plantarflexion). Standard principles governing frequency, volume, duration, and intensity of exercise known to provide maximal adaptation in both healthy and frail adults will be followed. Legs will be trained unilaterally.
Home-based program: Following 10 weeks of training, subjects will be given a home-based training program to continue indefinitely. Subjects in the TT+Power group will be given weights with instructions on use, and a walking program whereas those in the TT group will be given a walking program. To encourage compliance with the program, subjects will be telephoned weekly, and visited monthly. Subjects also will be requested to fill in a weekly log sheet detailing their exercise sessions and other physical activities, which is mailed to the trainer for feedback each week.
Outcomes: Outcomes will be measured prior to commencement of training, after 10 weeks training, and then after 6-months home based exercise.
The Primary outcome is the distance walked in 6-min. This test was selected because walking distance is an important criterion for community ambulation. It is related to functional impairment as well as strength of the lower limb muscles and aerobic fitness, avoids the problem of gait velocity being relevant only for short-distance ambulation, and is a robust measurement.
Secondary Outcomes:
- Other walking variables and balance variables: The total number of steps taken during waking hours, using an accelerometer with a large capacity data logger. Temporal and spatial variables associated with walking, as well as balance will be assessed.
- Lower limb muscular strength, power and endurance will be assessed using the pneumatic resistance machines.
- Cardiorespiratory fitness will be assessed from variables collected during a maximal effort cycle test and a multistage exercise test.
- Scales and questionnaires will provide an assessment of changes in the subject's psychological and functional states. Scales include a stroke impact scale, a self-efficacy scale, health related qualify of life questionnaire, and a geriatric depression scale.
- Conditions
- Stroke
- Being tested
- Partial Body-weight supported Treadmill Training, PBWST + Power training, "Usual" physiotherapy care
- Keywords
- PBWST training, Strength training, 6-min walking endurance, Cardiovascular fitness, Psychosocial attributes
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Partial Body-weight supported Treadmill TrainingProcedure or surgery
PBWST + Power trainingProcedure or surgery
"Usual" physiotherapy careProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
Distance walked in 6-min
Secondary outcomes (5)
Other walking variables and balance variables: *The total number of steps taken during waking hours, using an accelerometer with a large capacity data logger. *Temporal and spatial variables associated with walking, as well as balance will be assessed.
Lower limb muscular strength, power and endurance will be assessed using the pneumatic resistance machines.
Cardiorespiratory fitness will be assessed from variables collected during a maximal effort cycle test and a multistage exercise test.
Scales and questionnaires will provide an assessment of changes in the subject's psychological and functional states.
Scales include a stroke impact scale, a self-efficacy scale, health related qualify of life questionnaire, and a geriatric depression scale.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2005 (estimated)
- Study startMar 2004
- Study completionDec 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind
- Enrolment
- 102 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Sydney
- Sponsor type
- University, hospital or other
- Investigators
- Sharon L Kilbreath, PhD, Principal investigator, University of Sydney
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00108030
- Sponsor's protocol ID
- NHMRC 301974
- Other IDs
- Australia: NHMRC 301974
- Status last verified
- Dec 2015
- First submitted
- 12 Apr 2005
- Last updated
- 3 Dec 2015
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A RCT of Power Training and Treadmill Training to Improve Walking Ability in Sub-acute Stroke Patients
- ClinicalTrials.gov ID
- NCT00108030
- Acronym / sponsor ID
- NHMRC 301974
- Conditions
- Stroke
- Keywords
- PBWST training, Strength training, 6-min walking endurance, Cardiovascular fitness, Psychosocial attributes
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 102 participants (estimated)
- Lead sponsor
- University of SydneyUniversity, hospital or other
- Study start
- Mar 2004
- Study completion
- Dec 2006 (actual)
- First posted
- 13 Apr 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.
The specific aim of this project is to improve walking ability in persons following stroke using 'treadmill training plus power training'. This modality addresses the two major impairments followings stroke: weakness and incoordination, as well as loss of fitness. Importantly, this training will be presented at higher intensity and greater volume than is currently received. Furthermore, to ensure that persons continue to maintain the level of improvement from an intensive exercise program, we will also implement a behavioral change for long-term maintenance of exercise behavior in a less supervised environment. A randomized controlled clinical trial will be conducted in 102 sub-acute stroke patients to ascertain the efficacy of this approach to improving walking ability.
Hypotheses:
- Walking endurance will be increased to a greater degree in a patient group receiving treadmill plus muscle power training compared with a treadmill training only group, or 'usual care' group.
- Gait stability, muscle function, aerobic fitness and balance will improve more in a group receiving treadmill plus muscle power training, than either those in treadmill training or usual care patient groups.
- Habitual activity levels will be higher in the group receiving treadmill plus muscle power training compared with a treadmill training only group or 'usual care' group.
- The change in 6-minute walk distance will be positively related to changes in muscle power, strength and endurance, aerobic fitness, gait mechanics, and balance.
- Baseline depression and low self-efficacy will be associated with less robust adaptations to all types of training and lower rates of long-term compliance to the exercise prescription in the experimental groups.
Detailed description
To determine treatment efficacy, a single blinded, randomized controlled trial will be conducted. One hundred and two subjects will be randomly allocated to one of three groups comprising: (i) "Treadmill training + Power training" (TT+POWER), (ii) "Treadmill training" (TT), or (iii) "Usual Care" (USUAL). Those in the TT+POWER and TT will also receive 'usual care'. Subjects will be recruited within a week or two following their stroke, at which time they would be expected to be medically stable. Subjects in the training groups will attend training for 10 weeks, 3 times per week. Following the ten-week training program, subjects will be given a home-based training package to follow for 6 months.
Interventions:
Treadmill Training: The emphasis of the weight-supported treadmill training program will be initially to emphasize walking alignment. The amount of support will be reduced as quickly as possible to attain full weight-bearing on the motorized treadmill. Once a subject has attained full weight-bearing with correct segmental alignment, the emphasis will be on improving aerobic fitness whilst maintaining proper walking alignment.
Treadmill Training + Power Training: Subjects will undertake 30 min treadmill training, as described above, followed by 30 min of power training using pneumatic resistance equipment (Keiser Sports Health, Inc., Fresco, CA, USA) (leg press, knee extension and flexion, hip abduction, and plantarflexion). Standard principles governing frequency, volume, duration, and intensity of exercise known to provide maximal adaptation in both healthy and frail adults will be followed. Legs will be trained unilaterally.
Home-based program: Following 10 weeks of training, subjects will be given a home-based training program to continue indefinitely. Subjects in the TT+Power group will be given weights with instructions on use, and a walking program whereas those in the TT group will be given a walking program. To encourage compliance with the program, subjects will be telephoned weekly, and visited monthly. Subjects also will be requested to fill in a weekly log sheet detailing their exercise sessions and other physical activities, which is mailed to the trainer for feedback each week.
Outcomes: Outcomes will be measured prior to commencement of training, after 10 weeks training, and then after 6-months home based exercise.
The Primary outcome is the distance walked in 6-min. This test was selected because walking distance is an important criterion for community ambulation. It is related to functional impairment as well as strength of the lower limb muscles and aerobic fitness, avoids the problem of gait velocity being relevant only for short-distance ambulation, and is a robust measurement.
Secondary Outcomes:
- Other walking variables and balance variables: The total number of steps taken during waking hours, using an accelerometer with a large capacity data logger. Temporal and spatial variables associated with walking, as well as balance will be assessed.
- Lower limb muscular strength, power and endurance will be assessed using the pneumatic resistance machines.
- Cardiorespiratory fitness will be assessed from variables collected during a maximal effort cycle test and a multistage exercise test.
- Scales and questionnaires will provide an assessment of changes in the subject's psychological and functional states. Scales include a stroke impact scale, a self-efficacy scale, health related qualify of life questionnaire, and a geriatric depression scale.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind
Who may qualify
- Ages
- 45 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- First stroke resulting in hemiplegia;
- Mini-Mental State Exam score > 15;
- Distance walked in 6-min walk test is less than the lower limit of 'normal' according to reference equations for healthy adults (adjusted for gender, age, BMI [Body Mass Index])
- Score on walking subscale of the Motor Assessment Scale of ≥ 2.
Key exclusion criteria (7 listed)
- Unstable cardiac disease,
- Known un-repaired aortic or cerebral aneurysm
- Hemorrhagic stroke, symptomatic hernias, symptom limiting peripheral vascular disease,
- End-stage congestive cardiac failure,
- Any of the exclusion criteria contraindicating moderate exercise as outlined by American College of Sports Medicine guidelines for cardiac disease rehabilitation or for frail and elderly adults.
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 |
|---|---|---|
| Partial Body-weight supported Treadmill Training | Procedure or surgery | – |
| PBWST + Power training | Procedure or surgery | – |
| "Usual" physiotherapy care | Procedure or surgery | – |
Primary outcome
Distance walked in 6-min
5 secondary outcomes
Other walking variables and balance variables: *The total number of steps taken during waking hours, using an accelerometer with a large capacity data logger. *Temporal and spatial variables associated with walking, as well as balance will be assessed.
Lower limb muscular strength, power and endurance will be assessed using the pneumatic resistance machines.
Cardiorespiratory fitness will be assessed from variables collected during a maximal effort cycle test and a multistage exercise test.
Scales and questionnaires will provide an assessment of changes in the subject's psychological and functional states.
Scales include a stroke impact scale, a self-efficacy scale, health related qualify of life questionnaire, and a geriatric depression scale.
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 3 Dec 2015.
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Web-Based Tele-Rehabilitation Using Action Observation and Mirror Therapy for Subacute Stroke: A Randomized Controlled Trial
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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.
Sharon L Kilbreath, PhD principal investigator
University of Sydney
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Partial Body-weight supported Treadmill Training, PBWST + Power training and "Usual" physiotherapy care in people with Stroke, run by University of Sydney at 3 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 4 inclusion and 7 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 3 Dec 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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 combined 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.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Distance walked in 6-min. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 3 Dec 2015.