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

Cerebral Stroke Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00311025
• Other study ID #: S-03054
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: April 3, 2006
• Last updated: April 3, 2006
• Start date: September 2003
• Est. completion date: September 2005

Study information

• Verified date: September 2005
• Source: Oslo University College
• Contact: n/a
• Is FDA regulated: No
• Health authority: Norway: Medical Faculty, University of Oslo
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: September 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Educational/Counseling/Training

Related Conditions & MeSH terms

• Cerebral Stroke
• Stroke

Intervention

Procedure:
• intensive endurance, strength and balance exercises

Locations

Country	Name	City	State
Norway	Sykehuset Asker og Bærum HF, Postboks 83,	Rud

Sponsors (1)

Lead Sponsor	Collaborator
Oslo University College

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Motor Assessment Scale
Secondary	Bergs Balance Scale,
Secondary	Timed-Up-and-Go,
Secondary	6 minute walk test,
Secondary	Nottingham Health Profile,
Secondary	Martin Vigorimeter,
Secondary	Ashworth Scale,
Secondary	Barthel ADL index,
Secondary	Fillenbaum´s I-ADL,
Secondary	blood pressure,
Secondary	heart rate