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

NCT01818271 | Completed

• 1 other identifier: Hr2013:086
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 2

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. 1.assess the benefits and feasibility of the multi-functional group exercise intervention for balance and mobility in a community setting. Secondary objectives
2. 2.identify effective combinations of exercises \& activities that translate to increased abilities and participation levels.

Conditions

Sequelae of Stroke

Keywords

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

Outcome Measures

Primary Outcomes (2)

• 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

  pre and post intervention of 8 weeks

• 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.

  Pre and post intervention of 8 weeks

Secondary Outcomes (2)

• Berg Balance Scale

  pre and post intervention of 8 weeks

• Timed Up and Go Test

  Pre and Post intervention of 8 weeks

Other Outcomes (2)

• 6-minute wlak test

  Pre and Post intervention of 8 weeks

• Spatial-Temporal gait variables

  pre and post intervention of 8 weeks

Study Arms (2)

conventional physical Therapy

ACTIVE COMPARATOR

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

community-based group rehabilitation

EXPERIMENTAL

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

Interventions

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

conventional physical Therapy

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.

community-based group rehabilitation

Eligibility Criteria

• Age: 55 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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 .

Sponsors & Collaborators

• University of Manitoba: lead
• Manitoba Medical Service Foundation: collaborator

Study Sites (2)

School of Medical Rehabilitation , University of Mantioba

Winnipeg, Manitoba, R3e 0T6, Canada

Location

Riverview Health Centre

Winnipeg, Manitoba, R3T 1a3, Canada

Location

Study Officials

• Tony Szturm Szturm, PT, PhD

  Faculty of Medicine University of Manitoba

  PRINCIPAL INVESTIGATOR

• Sepideh Pooyania, MD

  Faculty of Medicine University of Manitoba

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 21, 2013
• First Posted: March 26, 2013
• Study Start: April 1, 2013
• Primary Completion: September 1, 2015
• Study Completion: September 1, 2015
• Last Updated: December 21, 2015

Record last verified: 2013-03

Locations

CA (2)