Clinical trial NCT00184431: Does Intensive Task Specific Training Improve Balance After Acute Stroke?
Official title: A Randomized Controlled Trial Comparing Intensive Task Specific Training With Traditional Follow up Care After Discharge From a Stroke Unit.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cerebrovascular Accident
Keywords: Cerebrovascular Accident
Physical Therapy Techniques
Musculoskeletal Equilibrium
Rehabilitation
Lead sponsor: Norwegian University of Science and Technology
Sponsor class: OTHER
Collaborators: name: St. Olavs Hospital
name: Norwegian Fund for Postgraduate Training in Physiotherapy
First posted: 2005-09-16
Enrollment: 62
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: The Berg Balance Scale
timeFrame: Inclusion, four weeks follow-up, twelve weeks follow-up and six months follow-up
Secondary outcomes:
measure: Mini Mental State Examination
timeFrame: Inclusion
measure: Scandinavian Stroke Scale
timeFrame: Inclusion
measure: Motor Assessment Scale
timeFrame: Inclusion, four weeks follow-up, twelve weeks follow-up, six months follow-up
measure: Timed Up and Go
timeFrame: Inclusion, four weeks follow-up, twelve weeks follow-up, six months follow-up
measure: Step Test
timeFrame: Inclusion, four weeks follow-up, twelve weeks follow-up, six months follow-up
measure: Walking speed
timeFrame: Inclusion, four weeks follow-up, twelve weeks follow-up, six months follow-up
measure: Barthel Index
timeFrame: Inclusion, four weeks follow-up, twelve weeks follow-up, six months follow-up
measure: Modified Rankin Scale
timeFrame: Inclusion, four weeks follow-up, twelve weeks follow-up, six months follow-up
measure: Fall Efficacy Scale
timeFrame: Inclusion, four weeks follow-up, twelve weeks follow-up, six months follow-up
measure: Stroke Impact Scale
timeFrame: Inclusion, four weeks follow-up, twelve weeks follow-up, six months follow-up
Other outcomes:
Locations:
city: Trondheim
country: Norway
facility: Norwegian University of Science and Technology
Study officials:
affiliation: Department of Neuroscience, Faculty of Medicine, Norwegian university of Science and Technology
name: Bent Indredavik, assoc-prof
role: STUDY_CHAIR
References:
citation: Askim T, Morkved S, Engen A, Roos K, Aas T, Indredavik B. Effects of a community-based intensive motor training program combined with early supported discharge after treatment in a comprehensive stroke unit: a randomized, controlled trial. Stroke. 2010 Aug;41(8):1697-703. doi: 10.1161/STROKEAHA.110.584284. Epub 2010 Jun 17.