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

This study has been completed.
Sponsor:
Collaborator:
Ontario Ministry of Health and Long Term Care
Information provided by (Responsible Party):
Vince DePaul, McMaster University
ClinicalTrials.gov Identifier:
NCT00561405
First received: November 20, 2007
Last updated: September 23, 2011
Last verified: September 2011
  Purpose

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.

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.


Condition Intervention Phase
Stroke
Behavioral: Motor Learning Walking Program
Behavioral: Body Weight Supported Treadmill Training
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by McMaster University:

Primary Outcome Measures:
  • Self selected over ground gait speed - 5 metre walk test [ Time Frame: 8 week follow up ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Six Minute Walk Test [ Time Frame: Post Intervention and 8 week follow up ] [ Designated as safety issue: No ]
  • Self selected over ground gait speed - 5 metre walk test [ Time Frame: Post Intervention ] [ Designated as safety issue: No ]
  • Balance related Self Efficacy - Activities-specific Balance Confidence Scale [ Time Frame: Post intervention and 8 week follow up ] [ Designated as safety issue: No ]
  • Average Daily Step Count - StepWatch 3 Step Activity Monitor [ Time Frame: Post Intervention and 8 Week Follow up ] [ Designated as safety issue: No ]
  • Dynamic Balance - Functional Balance Test [ Time Frame: Baseline, Post-intervention and 8 week Follow-up ] [ Designated as safety issue: No ]

    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.


  • Life Space Questionnaire [ Time Frame: Baseline, Post-intervention, and at 8 week follow up ] [ Designated as safety issue: No ]
    Self-report measure of mobility partipation.

  • Number of trainers required per treatment session [ Time Frame: Documented at every treatment session for both experimental and active comparison interventions. ] [ Designated as safety issue: No ]
  • Patient Specific Functional Scale [ Time Frame: Baseline, Post-intervention, Follow-up (8weeks) ] [ Designated as safety issue: No ]

    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).


  • Rating of Walking functional level - Modified Functional Walking Categories [ Time Frame: Baseline, Post-intervention, Follow-up (8 weeks) ] [ Designated as safety issue: No ]
  • Adverse event - Self-report of a fall(s) since baseline assessment [ Time Frame: Post Intervention Assessment ] [ Designated as safety issue: Yes ]
    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.

  • Adverse event - Falls (yes or no) [ Time Frame: Follow - up - 8 weeks after post-intervention assessment ] [ Designated as safety issue: Yes ]

    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)


  • Serious adverse events - ie. new stroke, myocardial infarction, overnight hospital admission, death [ Time Frame: Post-intervention, Follow up (8 weeks) ] [ Designated as safety issue: Yes ]
    Serious adverse events will be based on participant or caregiver report, and confirmed with primary care physician as appropriate.


Enrollment: 71
Study Start Date: December 2006
Study Completion Date: June 2011
Primary Completion Date: January 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Motor Learning Walking Program
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.
Behavioral: Motor Learning Walking Program
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
Other Name: Task oriented walking training
Active Comparator: Body weight supported treadmill training
Body 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.
Behavioral: Body Weight Supported 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.
Other Name: Treadmill training

  Eligibility

Ages Eligible for Study:   40 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00561405

Locations
Canada, Ontario
St. Joseph's Healthcare Hamilton
Hamilton, Ontario, Canada, L8N 4A6
Sponsors and Collaborators
McMaster University
Ontario Ministry of Health and Long Term Care
Investigators
Principal Investigator: Vincent G DePaul, PhD (c) McMaster University, Hamilton, ON, Canada
  More Information

No publications provided by McMaster University

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Vince DePaul, Physiotherapist (PT), PhD (candidate), McMaster University
ClinicalTrials.gov Identifier: NCT00561405     History of Changes
Other Study ID Numbers: 06356
Study First Received: November 20, 2007
Last Updated: September 23, 2011
Health Authority: Canada: Ministry of Health & Long Term Care, Ontario

Keywords provided by McMaster University:
Stroke
Walking
Motor learning
Skill acquisition

Additional relevant MeSH terms:
Stroke
Cerebral Infarction
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Brain Infarction
Brain Ischemia

ClinicalTrials.gov processed this record on August 21, 2014