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
  Purpose

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.


Condition Intervention Phase
Cerebral Stroke
Procedure: intensive endurance, strength and balance exercises
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Educational/Counseling/Training
Official Title: Stroke: Reduction of Physical Performance Post Stroke. Inactivity or Secondary Complications? How to Cope Daily Life Activities for as Long as Possible.

Resource links provided by NLM:


Further study details as provided by Oslo University College:

Primary Outcome Measures:
  • Motor Assessment Scale

Secondary Outcome Measures:
  • 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

Estimated Enrollment: 60
Study Start Date: September 2003
Estimated Study Completion Date: September 2005
Detailed Description:

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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00311025

Locations
Norway
Sykehuset Asker og Bærum HF, Postboks 83,
Rud, Norway, 1309
Sponsors and Collaborators
Oslo University College
Investigators
Principal Investigator: Birgitta M Langhammer, phd student Oslo University College
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00311025     History of Changes
Other Study ID Numbers: S-03054
Study First Received: April 3, 2006
Last Updated: April 3, 2006
Health Authority: Norway: Medical Faculty, University of Oslo

Keywords provided by Oslo University College:
stroke
physical therapy
rehabilitation
exercise
longterm follow-up

Additional relevant MeSH terms:
Cerebral Infarction
Stroke
Brain Diseases
Brain Infarction
Brain Ischemia
Cardiovascular Diseases
Central Nervous System Diseases
Cerebrovascular Disorders
Nervous System Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on October 23, 2014