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

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified March 2013 by University of Manitoba
Sponsor:
Collaborator:
Manitoba Medical Service Foundation
Information provided by (Responsible Party):
University of Manitoba
ClinicalTrials.gov Identifier:
NCT01818271
First received: March 21, 2013
Last updated: September 6, 2013
Last verified: March 2013
  Purpose

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.


Condition Intervention
Sequelae of Stroke
Behavioral: conventional physical therapy
Behavioral: community-based group rehabilitation

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
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;

Resource links provided by NLM:


Further study details as provided by University of Manitoba:

Primary Outcome Measures:
  • Gait speed [ Time Frame: pre and post intervention of 8 weeks ] [ Designated as safety issue: No ]
    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 [ Time Frame: Pre and post intervention of 8 weeks ] [ Designated as safety issue: No ]
    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 [ Time Frame: pre and post intervention of 8 weeks ] [ Designated as safety issue: No ]
  • Timed Up and Go Test [ Time Frame: Pre and Post intervention of 8 weeks ] [ Designated as safety issue: No ]

Other Outcome Measures:
  • 6-minute wlak test [ Time Frame: Pre and Post intervention of 8 weeks ] [ Designated as safety issue: No ]
  • Spatial-Temporal gait variables [ Time Frame: pre and post intervention of 8 weeks ] [ Designated as safety issue: No ]
    . 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


Estimated Enrollment: 24
Study Start Date: April 2013
Estimated Study Completion Date: April 2014
Estimated Primary Completion Date: April 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 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
Behavioral: 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
Experimental: 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.
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.

  Eligibility

Ages Eligible for Study:   55 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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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  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01818271

Contacts
Contact: Sepideh Pooyania, MD (204) 478-6219 spooyania@rhc.mb.ca
Contact: Tony Szturm, PT, PhD 204 787-4794 tony.szturm@med.umanitoba.ca

Locations
Canada, Manitoba
School of Medical Rehabilitation , University of Mantioba Recruiting
Winnipeg, Manitoba, Canada, R3e 0T6
Principal Investigator: Tony Szturm, PT, PhD         
Riverview Health Centre Recruiting
Winnipeg, Manitoba, Canada, R3T 1a3
Contact: Sepideh Pooyania, MD    (204) 478-6219    spooyania@rhc.mb.ca   
Sponsors and Collaborators
University of Manitoba
Manitoba Medical Service Foundation
Investigators
Principal Investigator: Tony Szturm Szturm, PT, PhD Faculty of Medicine University of Manitoba
Principal Investigator: Sepideh Pooyania, MD Faculty of Medicine University of Manitoba
  More Information

No publications provided

Responsible Party: University of Manitoba
ClinicalTrials.gov Identifier: NCT01818271     History of Changes
Other Study ID Numbers: Hr2013:086
Study First Received: March 21, 2013
Last Updated: September 6, 2013
Health Authority: Canada: Ethics Review Committee

Keywords provided by University of Manitoba:
community-stroke-rehabilitation,
group-exercise,
balance-mobility-exercise,
instrumented treadmill

Additional relevant MeSH terms:
Stroke
Cerebral Infarction
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Brain Infarction
Brain Ischemia

ClinicalTrials.gov processed this record on July 28, 2014