Sequelae of Stroke Clinical Trial
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;
| Verified date | March 2013 |
| Source | University of Manitoba |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | Canada: Ethics Review Committee |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 24 |
| Est. completion date | September 2015 |
| Est. primary completion date | September 2015 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 55 Years to 70 Years |
| Eligibility |
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 . |
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| Canada | Riverview Health Centre | Winnipeg | Manitoba |
| Canada | School of Medical Rehabilitation , University of Mantioba | Winnipeg | Manitoba |
| Lead Sponsor | Collaborator |
|---|---|
| University of Manitoba | Manitoba Medical Service Foundation |
Canada,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Other | 6-minute wlak test | Pre and Post intervention of 8 weeks | No | |
| Other | Spatial-Temporal gait variables | . 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 | pre and post intervention of 8 weeks | No |
| Primary | 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 | No |
| Primary | 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 | No |
| Secondary | Berg Balance Scale | pre and post intervention of 8 weeks | No | |
| Secondary | Timed Up and Go Test | Pre and Post intervention of 8 weeks | No |