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

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ClinicalTrials.gov Identifier: NCT00377689
Recruitment Status : Completed
First Posted : September 18, 2006
Last Update Posted : October 29, 2008
Sponsor:
Collaborators:
Information provided by:

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

Condition or disease Intervention/treatment Phase
Cerebrovascular Accident Musculoskeletal Equilibrium Behavioral: high intensity functional exercise Phase 2

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 Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 34 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Official Title: Evaluation of an Intervention Program Targeted at Improving Balance and Functional Skills After Stroke - a Randomized Controlled Study
Study Start Date : September 2006
Primary Completion Date : April 2008
Study Completion Date : April 2008
Arms and Interventions

Intervention Details:
    Behavioral: high intensity functional exercise
    high intensity functional exercise

Outcome Measures

Primary Outcome Measures :
  1. Improvement in balance [ Time Frame: post, 3 & 6 months ]

Secondary Outcome Measures :
  1. Reduced falls [ Time Frame: post, 3 & 6 months ]
  2. Improved self-efficacy [ Time Frame: post, 3 & 6 months ]
  3. Improved ADL [ Time Frame: post, 3 & 6 months ]
  4. Improved walking ability [ Time Frame: post, 3 & 6 months ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   55 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00377689


Locations
Sweden
Umeå University, department of Community science and rehabilitation
Umeå, Sweden, 90137
Sponsors and Collaborators
Umeå University
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
More Information

Responsible Party: Umea University, Mrs Eva Holmgren, RPt, PhD student, Umea University
ClinicalTrials.gov Identifier: NCT00377689     History of Changes
Other Study ID Numbers: Dnr 04-022
First Posted: September 18, 2006    Key Record Dates
Last Update Posted: October 29, 2008
Last Verified: October 2008

Keywords provided by Umeå University:
Accidental falls
Cerebrovascular accident
Balance
ADL
Self efficacy
Quality of Life
Gait parameters

Additional relevant MeSH terms:
Stroke
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases