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

McMaster University

Status and phase: Completed; Phase 2

Conditions: Stroke

Treatments: Behavioral: Body Weight Supported Treadmill Training; Behavioral: Motor Learning Walking Program

Study type: Interventional

Funder types: Other

Identifiers

NCT00561405

06356

Details and patient eligibility

About

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.

Enrollment: 71 patients

Sex: All

Ages: 40+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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71 participants in 2 patient groups

Motor Learning Walking Program

Experimental group

Description:

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.

Treatment:

Behavioral: Motor Learning Walking Program

Body weight supported treadmill training

Active Comparator group

Description:

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.

Treatment:

Behavioral: Body Weight Supported Treadmill Training