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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT00108030




Registration number
NCT00108030
Ethics application status
Date submitted
12/04/2005
Date registered
13/04/2005
Date last updated
3/12/2015

Titles & IDs
Public title
PBWST (Partial Body-Weight Supported Treadmill Training) and Muscle Power Training After Sub-acute Stroke
Scientific title
A RCT of Power Training and Treadmill Training to Improve Walking Ability in Sub-acute Stroke Patients
Secondary ID [1] 0 0
Australia: NHMRC 301974
Secondary ID [2] 0 0
NHMRC 301974
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Stroke 0 0
Condition category
Condition code
Stroke 0 0 0 0
Haemorrhagic
Stroke 0 0 0 0
Ischaemic

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Surgery - Partial Body-weight supported Treadmill Training
Treatment: Surgery - PBWST + Power training
Treatment: Surgery - "Usual" physiotherapy care

Treatment: Surgery: Partial Body-weight supported Treadmill Training


Treatment: Surgery: PBWST + Power training


Treatment: Surgery: "Usual" physiotherapy care
Intervention code [1] 0 0
Treatment: Surgery
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Distance walked in 6-min
Timepoint [1] 0 0
Secondary outcome [1] 0 0
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.
Timepoint [1] 0 0
Secondary outcome [2] 0 0
Lower limb muscular strength, power and endurance will be assessed using the pneumatic resistance machines.
Timepoint [2] 0 0
Secondary outcome [3] 0 0
Cardiorespiratory fitness will be assessed from variables collected during a maximal effort cycle test and a multistage exercise test.
Timepoint [3] 0 0
Secondary outcome [4] 0 0
Scales and questionnaires will provide an assessment of changes in the subject's psychological and functional states.
Timepoint [4] 0 0
Secondary outcome [5] 0 0
Scales include a stroke impact scale, a self-efficacy scale, health related qualify of life questionnaire, and a geriatric depression scale.
Timepoint [5] 0 0

Eligibility
Key inclusion criteria
- 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.
Minimum age
45 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Factorial
Other design features
Phase
Phase 2/Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/03/2004
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/12/2006
Sample size
Target
102
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
Rehabilitation Research Centre, University of Sydney - Sydney
Recruitment hospital [2] 0 0
School of Physiotherapy, University of Sydney - Sydney
Recruitment hospital [3] 0 0
Coorabel Brain Injury Unit, Royal Rehabilitation Centre Sydney - Sydney
Recruitment postcode(s) [1] 0 0
2141 - Sydney
Recruitment postcode(s) [2] 0 0
- Sydney

Funding & Sponsors
Primary sponsor type
Other
Name
University of Sydney
Address
Country

Ethics approval
Ethics application status

Summary
Brief 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.
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:

1. 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.

2. 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.

3. 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.

4. 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.

5. 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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT00108030
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Sharon L Kilbreath, PhD
Address 0 0
University of Sydney
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT00108030