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StrokePhase 2NCT00561405

A Comparison of Two Intensive Walking Training Interventions in Community Dwelling Individuals With History of Stroke

A Phase 2 study testing Motor Learning Walking Program and Body Weight Supported Treadmill Training in people with Stroke, run by McMaster University at 1 site in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Stroke is a major cause of disability in Canadian adults. Following a stroke, many people have difficulty walking in their home and in the community. The purpose of this study is to compare the effect of two different approaches to walking retraining in people who have had a stroke. Read more about this study

Who is it for?
Ages 40 years and older
Conditions the study is for
Stroke
What is being tested?
Motor Learning Walking Program and Body Weight Supported Treadmill Training
Could I receive a placebo?
No, everyone receives an active treatment
How many people
71 participants
Where
1 siteCanada
Study dates
Dec 2006to Jun 2011
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 40 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Stroke onset within previous 12 months
  • Age 40 or older
  • Able to follow 2 step verbal command (English),
  • Able to walk 10 metres without human assistance (may use walking aid)
  • Independent community ambulatory prior to stroke
  • Community dwelling
  • Approval from physician for participation in study

Who cannot join

  • Walking speed greater than 1.0 m/s without walking aid
  • Within normal limits on Modified Mini Mental Status test (age and education adjusted)
  • Documented global aphasia
  • Legal blindness
  • Unable to exercise due to the any of the following conditions
  • A recent significant change in resting ECG suggesting ischemia
Show all 20Show fewer
  • Recent Myocardial infarction (within 3 months) or other acute cardiac event
  • Unstable angina
  • Severe SOB at rest or with activities of daily living
  • Uncontrolled cardiac arrhythmias causing symptoms
  • Severe symptomatic aortic stenosis
  • Uncontrolled symptomatic heart failure
  • Acute pulmonary embolus or pulmonary infarction
  • Acute myocarditis or pericarditis
  • Suspected or known dissecting aneurysm
  • Acute systemic infection, accompanied by fever, body ache or swollen lymph glands
  • Uncontrolled hypertension (systolic > 200 mmHg, diastolic > 110 mmHg )
  • Severe peripheral vascular disease with sustained claudication (resulting in limited walking tolerance)
  • Severe lower extremity orthopedic problems with severe pain on weight bearing
  • Lower extremity amputation that requires prosthesis

Trial locations and contacts

1 site in 1 country.

Canada1 site

  • St. Joseph's Healthcare Hamilton

    Hamilton, Ontario, L8N 4A6

Other trials in Canada

About this study

Official title: A Motor Learning Based Walking Program Versus Body Weight Supported Treadmill Training in Community Dwelling Adults Within One Year of Stroke Onset: A Randomized Controlled Trial

Stroke is a major cause of disability in Canadian adults. Following a stroke, many people have difficulty walking in their home and in the community. The purpose of this study is to compare the effect of two different approaches to walking retraining in people who have had a stroke.

Individuals living in the community who have had recently had a stroke will be asked to participate in this study. Participants will be randomly assigned to one of two five week walking training programs. In one program, individuals will re-learn to walk in a variety of real-life situations. Practice sessions will encourage active problem solving by the participants. The other program will have participants practice walking on a treadmill while some of their body weight is supported by a special harness system. Participants will also be assisted by a physiotherapist to walk in a more normal manner.

Read more

Participants' will be assessed at the beginning of the study, after the 5 week training program and again, eight weeks later. The research assistant will assess their ability to walk, their confidence level and the average daily walking activity.

Primary Hypothesis: Individuals assigned to the Motor Learning Walking Program will improve their walking ability from baseline to follow up assessment significantly more than individuals assigned to the Treadmill Training Program.

The results of this study will help physiotherapists plan effective treatment programs for individuals with walking difficulties following stroke. It will also give researchers direction for future studies in the areas of walking retraining and motor skill development post-stroke.

Conditions
Stroke
Being tested
Motor Learning Walking Program, Body Weight Supported Treadmill Training
Keywords
Stroke, Walking, Motor learning, Skill acquisition
Medical subject headings
Stroke

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Motor Learning Walking ProgramBehavioural

    Also called Task oriented walking training

    Motor Learning principles based Walking Program (MLWP) Participants practice variety of real life over ground walking related activities. Order of practice, instructions, guidance and feedback are provided in a manner that facilitates cognitive engagement of learner. Sessions 45 minutes, 3x per week over 5 weeks for a total of 15 sessions

  • Body Weight Supported Treadmill TrainingBehavioural

    Also called Treadmill training

    Participants practice walking on a treadmill while supported with an overhead harness system. Up to 40% body weight support. Target Treadmill speed 2.0 mph. 1 or 2 Trainers (at least one Physical Therapist plus another Physical Therapist or Physiotherapy Assistant) will help guide participants leg, foot and trunk during treatment. Aim is to practice high numbers of repetition of the normal gait cycle on treadmill. Duration of sessions - 20 minutes of treadmill training within a 45 minute session ( 4 sets of 5 minutes of training with 5 minute rests). 3 sessions per week for 5 weeks. Total of 15 sessions.

Study groups in NCT00561405
Study groupRoleWhat they receive
Motor Learning Walking ProgramExperimentalMotor Learning principles based Walking Program (MLWP) Participants practice variety of real life over ground walking related activities. Order of practice, instructions, guidance and feedback are provided in a manner that facilitates cognitive engagement of learner.
Receives: Behavioral: Motor Learning Walking Program
Body weight supported treadmill trainingActive comparatorBody Weight Supported Treadmill Training. Participants walk on a treadmill while partially supported with an overhead harness system. Mass repetition of the normal gait cycle is encouraged through the support of the harness, the movement of the treadmill, and the assistance of one or two trainers to position limbs and trunk.
Receives: Behavioral: Body Weight Supported Treadmill Training

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Self selected over ground gait speed - 5 metre walk test

    Measured: 8 week follow up

Secondary outcomes (12)

  1. Six Minute Walk Test

    Measured: Post Intervention and 8 week follow up

  2. Self selected over ground gait speed - 5 metre walk test

    Measured: Post Intervention

  3. Balance related Self Efficacy - Activities-specific Balance Confidence Scale

    Measured: Post intervention and 8 week follow up

  4. Average Daily Step Count - StepWatch 3 Step Activity Monitor

    Measured: Post Intervention and 8 Week Follow up

  5. Dynamic Balance - Functional Balance Test

    Over a 9 m track - participants are required to perform 5 balance and walking related tasks. Participants are required to 1) rise from a chair, walk 3 m, 2) step up and down an 8 inch step, walk 3 m, 3) bend down to pick up and return a 2.5 kilo weight off floor, walk 3 m to marked spot on the floor, 4) turn 180 degrees and walk 9 m back to the chair, 5. sit back down in the chair.

    Each task is scored on a 4 point scale (total score of out 20) Participants are timed on how long it takes them to perform the entire circuit.

    Measured: Baseline, Post-intervention and 8 week Follow-up

  6. Life Space Questionnaire

    Self-report measure of mobility partipation.

    Measured: Baseline, Post-intervention, and at 8 week follow up

  7. Number of trainers required per treatment session

    Measured: Documented at every treatment session for both experimental and active comparison interventions.

  8. Patient Specific Functional Scale

    In this measure, participants are asked to identify 3 walking related functional activities that they currently have some difficulty performing and would like to improve with treatment. For each activity, the participant rates their current ability to perform the task on a numeric rating scale of 0 to 10.

    At Post-intervention and Follow-up, participants re-rate their current ability on the same activites (without seeing their previous score).

    Measured: Baseline, Post-intervention, Follow-up (8weeks)

  9. Rating of Walking functional level - Modified Functional Walking Categories

    Measured: Baseline, Post-intervention, Follow-up (8 weeks)

  10. Adverse event - Self-report of a fall(s) since baseline assessment

    Participants will be asked whether or not they have had a fall since baseline assessment. Details of the fall(s) will be recorded. Fall report based on participant recall - no other tools (e.g. diary) will be used.

    Measured: Post Intervention Assessment

  11. Adverse event - Falls (yes or no)

    Participant asked to report whether or not they had a fall since Post Intervention assessment. Details of the fall will be provided.

    Based on participant recall - no other tools for falls recording will be used (ie. will not be using falls diary)

    Measured: Follow - up - 8 weeks after post-intervention assessment

  12. Serious adverse events - ie. new stroke, myocardial infarction, overnight hospital admission, death

    Serious adverse events will be based on participant or caregiver report, and confirmed with primary care physician as appropriate.

    Measured: Post-intervention, Follow up (8 weeks)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Nov 2007 (estimated)
  2. Study startDec 2006
  3. Primary completionJan 2011
  4. Study completionJun 2011

Resources

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
Who is masked
Outcomes assessor
Enrolment
71 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00561405
Sponsor's protocol ID
06356
Status last verified
Sep 2011
First submitted
20 Nov 2007
Last updated
26 Sep 2011
Results posted
No
Data monitoring committee
No

Publications

  • DePaul VG, Wishart LR, Richardson J, Lee TD, Thabane L. Varied overground walking-task practice versus body-weight-supported treadmill training in ambulatory adults within one year of stroke: a randomized controlled trial protocol. BMC Neurol. 2011 Oct 21;11:129. doi: 10.1186/1471-2377-11-129.

    PubMed 22018267

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Motor Learning Walking Program and Body Weight Supported Treadmill Training in people with Stroke, run by McMaster University at 1 site in Canada.

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 7 inclusion and 20 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 26 Sep 2011. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. 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?

Self selected over ground gait speed - 5 metre walk test (time frame: 8 week follow up). 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 NCT00561405, which also lists 1 linked publication.

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 26 Sep 2011.

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