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OpenTrials
Completed

NCT Number: NCT01818271

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

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.

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Key information

Conditions

Age range

55 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Riverview Health Centre, Winnipeg, Manitoba, Canada

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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 ,
  • Aged 50-70 years,
  • Montreal Cognitive Assessment score greater than 26,
  • English-speaking and possess the ability to understand the nature of the study and provide informed consent,
  • 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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Treatment and study plan

Conventional Physical Therapy

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

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.

Primary outcomes

  1. Gait speed

    Time frame: pre and post intervention of 8 weeks

    Proportion of participants with an improved functional level of walking As per LEAPS multi-centre RCT.47 Improved functional level was defined as; (a) the ability to walk independently at a speed of 0.8 m per second or faster for persons with initially moderate gait impairment , or (b) ability to walk independently at a speed of 0.4 m per second or faster for persons with initially severe gait impairment. These transitions are associated with improvements in home or community ambulation, functional status, and quality of life.50

  2. Stroke Impact Scale

    Time frame: Pre and post intervention of 8 weeks

    This scale is a self reported, stroke specific, valid, reliable, and responsive measure that includes 59 items and assesses eight domains related to activities and participation.

Secondary outcomes

  1. Berg Balance Scale

    Time frame: pre and post intervention of 8 weeks

  2. Timed Up and Go Test

    Time frame: Pre and Post intervention of 8 weeks

Other outcomes

  1. 6-minute wlak test

    Time frame: Pre and Post intervention of 8 weeks

  2. Spatial-Temporal gait variables

    Time frame: pre and post intervention of 8 weeks

    . Spatial-Temporal gait parameters using instrumented walkway.56 Average walking speed (in 4 meters) mean and variance measurement (over 20 steps) will be obtained for the following parameters: swing and stance duration, single support

Sponsors and collaborators

Lead sponsor

University of Manitoba

Other

Collaborators

  • Manitoba Medical Service Foundation

Registry information

Official study title

Phase 1 Study of the Effects of a Community-based Group Rehabilitation Program for Dynamic Balance and Mobility; as an Alternate to Out-patient Rehabilitation Post Stroke;

Important dates

Study start
2013
Primary completion
2015
Study completion
2015
First posted
Mar 26, 2013
Registry last updated
Dec 21, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.