Evaluation of an Intervention Program Targeted at Improving Balance and Functional Skills After Stroke

October 27, 2008 updated by: Umeå University

Evaluation of an Intervention Program Targeted at Improving Balance and Functional Skills After Stroke - a Randomized Controlled Study

The purpose of this study is to evaluate a 5-week intervention program targeted at improving balance and functional skills for people with stroke.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Many people with stroke experience a deterioration in balance and a functional decline due to hemiplegic muscle strength. This tend to restrict the persons activity in daily life and also leads to a low falls self efficacy.

High intensity exercise have shown to be effective for improving strength and balance for older people in general living in residential care facilities. It is interesting to see if this high intensity exercise also is applicable in the older stroke population.

Comparison: An intervention group receives three training sessions per week and one theory session per week during 5 weeks, compared to a control group that receives one theory session per week during 5 weeks.

Study Type

Interventional

Enrollment (Actual)

34

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Sweden
      • Umeå, Sweden, 90137
        • Umeå University, department of Community science and rehabilitation

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

55 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 55 years of age or older
  • stroke diagnosis 3-6 months prior to inclusion
  • ability to walk 10 meter with or without assistive device
  • ability to understand simple instructions

Exclusion Criteria:

  • TIA
  • independent in walking outdoors
  • serious visual impairment
  • serious hearing impairment
  • long distance to intervention station

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Improvement in balance
Time Frame: post, 3 & 6 months
post, 3 & 6 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Reduced falls
Time Frame: post, 3 & 6 months
post, 3 & 6 months
Improved self-efficacy
Time Frame: post, 3 & 6 months
post, 3 & 6 months
Improved ADL
Time Frame: post, 3 & 6 months
post, 3 & 6 months
Improved walking ability
Time Frame: post, 3 & 6 months
post, 3 & 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Umeå University

Collaborators

Vardalinstitutet The Swedish Institute for Health Sciences
Erik & AnnMarie Detlofs Foundation
The Swedish National Stroke society
The Northern County Councils Regional Federation

Investigators

  • Principal Investigator: Eva Holmgren, PhD student, Umeå University & The Vårdal Institute
  • Study Chair: Per Wester, MD Professor, Umeå University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2006

Primary Completion (Actual)

April 1, 2008

Study Completion (Actual)

April 1, 2008

Study Registration Dates

First Submitted

September 15, 2006

First Submitted That Met QC Criteria

September 15, 2006

First Posted (Estimate)

September 18, 2006

Study Record Updates

Last Update Posted (Estimate)

October 29, 2008

Last Update Submitted That Met QC Criteria

October 27, 2008

Last Verified

October 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Dnr 04-022

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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