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Completed

NCT Number: NCT00311025

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

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.

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Key information

Age range

0 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Sykehuset Asker og Bærum HF, Postboks 83,

Rud, 1309, Norway

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

intensive endurance, strength and balance exercises

Procedure

Primary outcomes

  1. Motor Assessment Scale

Secondary outcomes

  1. Bergs Balance Scale,

  2. Timed-Up-and-Go,

  3. 6 minute walk test,

  4. Nottingham Health Profile,

  5. Martin Vigorimeter,

  6. Ashworth Scale,

  7. Barthel ADL index,

  8. Fillenbaum´s I-ADL,

  9. blood pressure,

  10. heart rate

Sponsors and collaborators

Lead sponsor

Oslo University College

Other

Registry information

Official study title

Stroke: Reduction of Physical Performance Post Stroke. Inactivity or Secondary Complications? How to Cope Daily Life Activities for as Long as Possible.

Important dates

Study start
2003
Study completion
2005
First posted
Apr 5, 2006
Registry last updated
Apr 5, 2006

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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