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

Stroke Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00561405
• Other study ID #: 06356
• Status: Completed
• Phase: Phase 2
• First received: November 20, 2007
• Last updated: September 23, 2011
• Start date: December 2006
• Est. completion date: June 2011

Study information

• Verified date: September 2011
• Source: McMaster University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Ministry of Health & Long Term Care, Ontario
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 71
• Est. completion date: June 2011
• Est. primary completion date: January 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years and older

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Stroke

Intervention

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
• 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.

Locations

Country	Name	City	State
Canada	St. Joseph's Healthcare Hamilton	Hamilton	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
McMaster University	Ontario Ministry of Health and Long Term Care

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Self selected over ground gait speed - 5 metre walk test		8 week follow up	No
Secondary	Six Minute Walk Test		Post Intervention and 8 week follow up	No
Secondary	Self selected over ground gait speed - 5 metre walk test		Post Intervention	No
Secondary	Balance related Self Efficacy - Activities-specific Balance Confidence Scale		Post intervention and 8 week follow up	No
Secondary	Average Daily Step Count - StepWatch 3 Step Activity Monitor		Post Intervention and 8 Week Follow up	No
Secondary	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.	Baseline, Post-intervention and 8 week Follow-up	No
Secondary	Life Space Questionnaire	Self-report measure of mobility partipation.	Baseline, Post-intervention, and at 8 week follow up	No
Secondary	Number of trainers required per treatment session		Documented at every treatment session for both experimental and active comparison interventions.	No
Secondary	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).	Baseline, Post-intervention, Follow-up (8weeks)	No
Secondary	Rating of Walking functional level - Modified Functional Walking Categories		Baseline, Post-intervention, Follow-up (8 weeks)	No
Secondary	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.	Post Intervention Assessment	Yes
Secondary	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)	Follow - up - 8 weeks after post-intervention assessment	Yes
Secondary	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.	Post-intervention, Follow up (8 weeks)	Yes