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Stroke: Reduction of Physical Performance Post Stroke. Inactivity or Secondary Complications?

This study has been completed.
Sponsor:
Information provided by:
Oslo University College
ClinicalTrials.gov Identifier:
NCT00311025
First received: April 3, 2006
Last updated: NA
Last verified: September 2005
History: No changes posted

April 3, 2006
April 3, 2006
September 2003
Not Provided
Motor Assessment Scale
Same as current
No Changes Posted
  • Bergs Balance Scale,
  • Timed-Up-and-Go,
  • 6 minute walk test,
  • Nottingham Health Profile,
  • Martin Vigorimeter,
  • Ashworth Scale,
  • Barthel ADL index,
  • Fillenbaum´s I-ADL,
  • blood pressure,
  • heart rate
Same as current
Not Provided
Not Provided
 
Stroke: Reduction of Physical Performance Post Stroke. Inactivity or Secondary Complications?
Stroke: Reduction of Physical Performance Post Stroke. Inactivity or Secondary Complications? How to Cope Daily Life Activities for as Long as Possible.

The purpose of this project is to follow first-ever- acute stroke patients from onset, one, two and four years post stroke and study the effect of two different approaches of exercises implemented the first year post-stroke.

Stroke is a major cause of disability and the long-term effects of stroke often lead to need of rehabilitation services. It has been shown that intensive stroke unit care and functional exercises are beneficial in the acute rehabilitation of stroke. The duration of the rehabilitation of patients with acute stroke is decreasing, leaving patients with not complete recovery at discharge in need of follow-up services. There is a general assumption that physical exercises are beneficial at all stages of stroke but it is questionable if these benefits are sustained after treatment ends. There are, to our knowledge, no longitudinal studies of non-interrupted regular physical exercises from the acute phase till one year post stroke.

The purpose of this project is to follow first-ever- acute stroke patients from onset, one, two and four years post stroke. All acute stroke patients will be treated in a stroke unit and the physiotherapy treatment will be according to Motor Relearning Programme principles with functional goals, environmental context and early mobilisation. When patients are discharged they will be block randomised and stratified according to gender and hemisphere lesion into two groups. Group 1 will be offered an intensive follow-up programme, which will run four times in the post-stroke year with a total amount of 80 hours of physiotherapy. The physiotherapy treatment will be focused on physical endurance, strength and balance.

Group 2, or the control group, will be offered the same physiotherapy programme that is practised within the community as of now (2003) that is when the need for follow-up is considered by someone involved. The physiotherapy then given is according to specified needs e.g. walking capacity, transfers and assistive devices.

Interventional
Phase 1
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Educational/Counseling/Training
Cerebral Stroke
Procedure: intensive endurance, strength and balance exercises
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
60
September 2005
Not Provided

Inclusion Criteria:

  • First-time ever stroke
  • Neurological signs
  • Computer tomography confirmed stroke
  • Voluntary participation

Exclusion Criteria:

  • Subarachnoid bleeding
  • Tumour
  • Other serious illness
  • Brain stem or cerebellum stroke
Both
Not Provided
No
Contact information is only displayed when the study is recruiting subjects
Norway
 
NCT00311025
S-03054
Not Provided
Not Provided
Oslo University College
Not Provided
Principal Investigator: Birgitta M Langhammer, phd student Oslo University College
Oslo University College
September 2005

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP