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

NCT ID: NCT00311025

Last Updated: 2006-04-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-09-30

Study Completion Date

2005-09-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Cerebral Stroke

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

ECT

Blinding Strategy

DOUBLE

Interventions

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intensive endurance, strength and balance exercises

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

0 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Oslo University College

OTHER

Sponsor Role lead

Principal Investigators

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Birgitta M Langhammer, phd student

Role: PRINCIPAL_INVESTIGATOR

Oslo University College

Locations

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Sykehuset Asker og Bærum HF, Postboks 83,

Rud, , Norway

Site Status

Countries

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Norway

Other Identifiers

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S-03054

Identifier Type: -

Identifier Source: org_study_id