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

Primary Purpose

Sequelae of Stroke

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
conventional physical therapy
community-based group rehabilitation
Sponsored by
University of Manitoba
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Sequelae of Stroke focused on measuring community-stroke-rehabilitation,, group-exercise,, balance-mobility-exercise,, instrumented treadmill

Eligibility Criteria

55 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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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Sites / Locations

  • School of Medical Rehabilitation , University of Mantioba
  • Riverview Health Centre

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

conventional physical Therapy

community-based group rehabilitation

Arm Description

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 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.

Outcomes

Primary Outcome Measures

Gait speed
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
Stroke Impact Scale
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 Outcome Measures

Berg Balance Scale
Timed Up and Go Test

Full Information

First Posted
March 21, 2013
Last Updated
December 18, 2015
Sponsor
University of Manitoba
Collaborators
Manitoba Medical Service Foundation
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1. Study Identification

Unique Protocol Identification Number
NCT01818271
Brief Title
Effects of a Community-based Group Rehabilitation Program for Dynamic Balance and Mobility Post Stroke
Official 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;
Study Type
Interventional

2. Study Status

Record Verification Date
March 2013
Overall Recruitment Status
Completed
Study Start Date
April 2013 (undefined)
Primary Completion Date
September 2015 (Actual)
Study Completion Date
September 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Manitoba
Collaborators
Manitoba Medical Service Foundation

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sequelae of Stroke
Keywords
community-stroke-rehabilitation,, group-exercise,, balance-mobility-exercise,, instrumented treadmill

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
24 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
conventional physical Therapy
Arm Type
Active Comparator
Arm Description
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
Arm Title
community-based group rehabilitation
Arm Type
Experimental
Arm Description
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
Intervention Name(s)
conventional physical therapy
Intervention Description
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
Intervention Name(s)
community-based group rehabilitation
Intervention Description
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 Outcome Measure Information:
Title
Gait speed
Description
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
Time Frame
pre and post intervention of 8 weeks
Title
Stroke Impact Scale
Description
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.
Time Frame
Pre and post intervention of 8 weeks
Secondary Outcome Measure Information:
Title
Berg Balance Scale
Time Frame
pre and post intervention of 8 weeks
Title
Timed Up and Go Test
Time Frame
Pre and Post intervention of 8 weeks
Other Pre-specified Outcome Measures:
Title
6-minute wlak test
Time Frame
Pre and Post intervention of 8 weeks
Title
Spatial-Temporal gait variables
Description
. 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
Time Frame
pre and post intervention of 8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
55 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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 . -
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tony Szturm Szturm, PT, PhD
Organizational Affiliation
Faculty of Medicine University of Manitoba
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Sepideh Pooyania, MD
Organizational Affiliation
Faculty of Medicine University of Manitoba
Official's Role
Principal Investigator
Facility Information:
Facility Name
School of Medical Rehabilitation , University of Mantioba
City
Winnipeg
State/Province
Manitoba
ZIP/Postal Code
R3e 0T6
Country
Canada
Facility Name
Riverview Health Centre
City
Winnipeg
State/Province
Manitoba
ZIP/Postal Code
R3T 1a3
Country
Canada

12. IPD Sharing Statement

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

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