Effects of a Community-based Group Rehabilitation Program for Dynamic Balance and Mobility Post Stroke

NCT ID: NCT01818271

Last Updated: 2015-12-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-04-30
• Study Completion Date: 2015-09-30

Brief Summary

Stroke patients clearly benefit from intensive and coordinated inpatient care. While inpatient rehabilitation care is the preferred form for many patients post-stroke, due to access and financial barriers, many patients do not have this option. Community, outpatient rehabilitation programs will allow the patients with moderately disabling strokes the opportunity to maintain or augment gains achieved during inpatient stroke rehabilitation , while allowing some patients with mild disability to avoid inpatient rehabilitation completely.

Objective: Phase 1 randomized control trial to test the efficiency and effectiveness of treating adults who have suffered a single stroke using the following essential treatment components; a) community setting, b) group activity program, c) flexible, task-specific, computer-based exercise regime This program is designed to allow an extension of the in-patient rehabilitation experience to a community-based setting, in a cost-effective manner using paraprofessional staff and rehabilitation specialists, to provide a challenging, functional program to promote recovery and independence from physical impairments affecting balance and walking.

The specific objectives are to:

1. assess the benefits and feasibility of the multi-functional group exercise intervention for balance and mobility in a community setting. Secondary objectives

2. identify effective combinations of exercises & activities that translate to increased abilities and participation levels.

Hypothesis: Intense training targeting standing balance, and walking will significantly improve stroke clients' functional mobility. Training in a group setting and incorporating interactive and engaging computer gaming further provides the benefits of motivation and peer support while providing treatment in a cost effective manner.

Conditions

Sequelae of Stroke

Keywords

community-stroke-rehabilitation,; group-exercise,; balance-mobility-exercise,; instrumented treadmill

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

conventional physical Therapy

will receive a conventional out-patient program which will include: lower extremity stretching and strengthening exercise; fitness using cycle ergometer; balance exercises in standing; over ground walking and stair exercises

Group Type: ACTIVE_COMPARATOR

conventional physical therapy

Intervention Type: BEHAVIORAL

will receive a conventional out-patient program which will include: lower extremity stretching and strengthening exercise; fitness using cycle ergometer; balance exercises in standing; over ground walking and stair exercises

community-based group rehabilitation

Group training will include different workstations to target dynamic standing balance and walking. The key features includes facilitate repetition of task-related movements, tailored to the patient and patient's goals, in a meaningful context. Specifically:

• Advanced dynamic tasks, including stepping and other transitional tasks to treadmill & over ground walking) with use of various inexpensive exercise "assistive" equipment such as mini-exercise stepper or elliptical machines.
• Treadmill walking exercise program.

Group Type: EXPERIMENTAL

community-based group rehabilitation

Intervention Type: BEHAVIORAL

Group training will include different workstations to target dynamic standing balance and walking. The key features includes facilitate repetition of task-related movements, tailored to the patient and patient's goals, in a meaningful context. Specifically:

• Advanced dynamic tasks, including stepping and other transitional tasks to treadmill & over ground walking) with use of various inexpensive exercise "assistive" equipment such as mini-exercise stepper or elliptical machines.
• Treadmill walking exercise program.

Interventions

conventional physical therapy

will receive a conventional out-patient program which will include: lower extremity stretching and strengthening exercise; fitness using cycle ergometer; balance exercises in standing; over ground walking and stair exercises

Intervention Type: BEHAVIORAL

community-based group rehabilitation

Group training will include different workstations to target dynamic standing balance and walking. The key features includes facilitate repetition of task-related movements, tailored to the patient and patient's goals, in a meaningful context. Specifically:

• Advanced dynamic tasks, including stepping and other transitional tasks to treadmill & over ground walking) with use of various inexpensive exercise "assistive" equipment such as mini-exercise stepper or elliptical machines.
• Treadmill walking exercise program.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

1. community dwelling individuals, who have suffered a single stroke of thrombic -embolic or hemorrhagic origin in the last 3-12 months and are waiting for outpatient rehabilitation ,

2. Aged 50-70 years,

3. Montreal Cognitive Assessment score greater than 26,

4. English-speaking and possess the ability to understand the nature of the study and provide informed consent,

5. Independent in sit to stand transfer and ambulatory functions, with or without an assistive device (cane or walker), f ) Gait speed (average over 25 meters) between 0.3 and 0.8 m/s and Berg Balance Scale score of less than 45.

Exclusion Criteria

Any medical condition or disability that prevents participation in an exercise program. For example, a reported medical history of current treatment for cancer, kidney disease, recent fracture, uncontrolled diabetes or seizure disorder, uncontrolled cardiovascular-related problems .

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• Minimum Eligible Age: 55 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Manitoba Medical Service Foundation

OTHER

Sponsor Role: collaborator

University of Manitoba

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Tony Szturm Szturm, PT, PhD

Role: PRINCIPAL_INVESTIGATOR

Faculty of Medicine University of Manitoba

Sepideh Pooyania, MD

Role: PRINCIPAL_INVESTIGATOR

Faculty of Medicine University of Manitoba

Locations

School of Medical Rehabilitation , University of Mantioba

Winnipeg, Manitoba, Canada

Riverview Health Centre

Winnipeg, Manitoba, Canada

Countries

Canada

Other Identifiers

Hr2013:086

Identifier Type: -

Identifier Source: org_study_id