Clinical trial NCT01818271: 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
Overall status: COMPLETED
Phase: NA
Conditions: Sequelae of Stroke
Keywords: community-stroke-rehabilitation,
group-exercise,
balance-mobility-exercise,
instrumented treadmill
Lead sponsor: University of Manitoba
Sponsor class: OTHER
Collaborators: name: Manitoba Medical Service Foundation
First posted: 2013-03-26
Enrollment: 24
Sex: ALL
Minimum age (years): 55
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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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Primary outcomes:
measure: Gait speed
timeFrame: pre and post intervention of 8 weeks
measure: Stroke Impact Scale
timeFrame: Pre and post intervention of 8 weeks
Secondary outcomes:
measure: Berg Balance Scale
timeFrame: pre and post intervention of 8 weeks
measure: Timed Up and Go Test
timeFrame: Pre and Post intervention of 8 weeks
Other outcomes:
measure: 6-minute wlak test
timeFrame: Pre and Post intervention of 8 weeks
measure: Spatial-Temporal gait variables
timeFrame: pre and post intervention of 8 weeks
Locations:
city: Winnipeg
country: Canada
facility: School of Medical Rehabilitation , University of Mantioba
state: Manitoba
city: Winnipeg
country: Canada
facility: Riverview Health Centre
state: Manitoba
Study officials:
affiliation: Faculty of Medicine University of Manitoba
name: Tony Szturm Szturm, PT, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Faculty of Medicine University of Manitoba
name: Sepideh Pooyania, MD
role: PRINCIPAL_INVESTIGATOR
References: