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

Primary Purpose

Cerebral Stroke

Status
Completed
Phase
Phase 1
Locations
Norway
Study Type
Interventional
Intervention
intensive endurance, strength and balance exercises
Sponsored by
Oslo University College
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional educational/counseling/training trial for Cerebral Stroke focused on measuring stroke, physical therapy, rehabilitation, exercise, longterm follow-up

Eligibility Criteria

0 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Sykehuset Asker og Bærum HF, Postboks 83,

Outcomes

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

Full Information

First Posted
April 3, 2006
Last Updated
April 3, 2006
Sponsor
Oslo University College
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1. Study Identification

Unique Protocol Identification Number
NCT00311025
Brief Title
Stroke: Reduction of Physical Performance Post Stroke. Inactivity or Secondary Complications?
Official Title
Stroke: Reduction of Physical Performance Post Stroke. Inactivity or Secondary Complications? How to Cope Daily Life Activities for as Long as Possible.
Study Type
Interventional

2. Study Status

Record Verification Date
September 2005
Overall Recruitment Status
Completed
Study Start Date
September 2003 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
September 2005 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Oslo University College

4. Oversight

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cerebral Stroke
Keywords
stroke, physical therapy, rehabilitation, exercise, longterm follow-up

7. Study Design

Primary Purpose
Educational/Counseling/Training
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
60 (false)

8. Arms, Groups, and Interventions

Intervention Type
Procedure
Intervention Name(s)
intensive endurance, strength and balance exercises
Primary Outcome Measure Information:
Title
Motor Assessment Scale
Secondary Outcome Measure Information:
Title
Bergs Balance Scale,
Title
Timed-Up-and-Go,
Title
6 minute walk test,
Title
Nottingham Health Profile,
Title
Martin Vigorimeter,
Title
Ashworth Scale,
Title
Barthel ADL index,
Title
Fillenbaum´s I-ADL,
Title
blood pressure,
Title
heart rate

10. Eligibility

Sex
All
Minimum Age & Unit of Time
0 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Birgitta M Langhammer, phd student
Organizational Affiliation
Oslo University College
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sykehuset Asker og Bærum HF, Postboks 83,
City
Rud
ZIP/Postal Code
1309
Country
Norway

12. IPD Sharing Statement

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