A Randomized Controlled Trial Comparing Intensive Task Specific Training With Traditional Follow up Care After Discharge From a Stroke Unit.
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 62
- Locations
- 1
- Primary Endpoint
- The Berg Balance Scale
Study Overview
Brief Summary
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
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Participant)
Eligibility Criteria
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
A
Intensive task specific balance training
Intervention: Physical therapy technique and exercises (Behavioral)
B
Traditional physical therapy
Intervention: Physical therapy technique and exercises (Behavioral)
Outcomes
Primary Outcomes
The Berg Balance Scale
Time Frame: Inclusion, four weeks follow-up, twelve weeks follow-up and six months follow-up
Secondary Outcomes
- 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)