Does Intensive Task Specific Training Improve Balance After Acute Stroke?

Study Overview
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Brief Summary
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The aim of this study is to investigate whether additional task specific physiotherapy treatment and a self administrated home training program results in better balance compared to traditional follow up care.

Detailed Description
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Increased risk of falling is a major problem after stroke and impaired balance is one of the main reasons for falling. Early and intensive physiotherapy seems to be beneficial for functional outcome after stroke although it is still unknown whether one specific physiotherapy technique is better than another. Comparison: Traditional follow up care by the community health care system with additional task specific physiotherapy three times a week and a daily self administrated home training program compared to traditional follow up care by the community health care system.

Official Title
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A Randomized Controlled Trial Comparing Intensive Task Specific Training With Traditional Follow up Care After Discharge From a Stroke Unit.

Conditions
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Cerebrovascular Accident

Intervention / Treatment
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* Behavioral: Physical therapy technique and exercises


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Admitted to the stroke unit with a diagnosis of stroke Living in the city of Trondheim Included 4 - 14 days after first sign of symptoms Modified Rankin Scale > 3 before admission to hospital Scandinavian Stroke Scale (SSS) less than 58 points and more than 14 points SSS leg item less than 6 points or SSS movement item less than 12 points Discharged to home or a rehabilitation clinic Mini Mental State Examination Score more than 20 points Able and willing to provide informed consent Exclusion Criteria: Seriously heart- and lung-diseases Other diseases which makes it difficult to evaluate the function Already included in the trial
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: A<br>Intensive task specific balance training | Behavioral: Physical therapy technique and exercises<br>* The experimental group receives task specific physical therapy three times a week for the first four weeks after discharge from hospital and one session pr week for the next eight weeks in addition to ordinary physical therapy The active comparator group receives only ordinary physical therapy during this period.<br>|
| Active Comparator: B<br>Traditional physical therapy | Behavioral: Physical therapy technique and exercises<br>* The experimental group receives task specific physical therapy three times a week for the first four weeks after discharge from hospital and one session pr week for the next eight weeks in addition to ordinary physical therapy The active comparator group receives only ordinary physical therapy during this period.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Berg Balance Scale |  | Inclusion, four weeks follow-up, twelve weeks follow-up and six months follow-up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mini Mental State Examination |  | Inclusion | 
| Scandinavian Stroke Scale |  | Inclusion | 
| Motor Assessment Scale |  | Inclusion, four weeks follow-up, twelve weeks follow-up, six months follow-up | 
| Timed Up and Go |  | Inclusion, four weeks follow-up, twelve weeks follow-up, six months follow-up | 
| Step Test |  | Inclusion, four weeks follow-up, twelve weeks follow-up, six months follow-up | 
| Walking speed |  | Inclusion, four weeks follow-up, twelve weeks follow-up, six months follow-up | 
| Barthel Index |  | Inclusion, four weeks follow-up, twelve weeks follow-up, six months follow-up | 
| Modified Rankin Scale |  | Inclusion, four weeks follow-up, twelve weeks follow-up, six months follow-up | 
| Fall Efficacy Scale |  | Inclusion, four weeks follow-up, twelve weeks follow-up, six months follow-up | 
| Stroke Impact Scale |  | Inclusion, four weeks follow-up, twelve weeks follow-up, six months follow-up | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cerebrovascular Accident, Physical Therapy Techniques, Musculoskeletal Equilibrium, Rehabilitation