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

This study has been completed.
Sponsor:
Collaborators:
Vardalinstitutet The Swedish Institute for Health Sciences
Erik & AnnMarie Detlofs Foundation
The Swedish National Stroke society
The Northern County Councils Regional Federation
Information provided by:
Umeå University
ClinicalTrials.gov Identifier:
NCT00377689
First received: September 15, 2006
Last updated: October 27, 2008
Last verified: October 2008
History of Changes
  Purpose

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 Intervention Phase
Cerebrovascular Accident
Musculoskeletal Equilibrium
 Behavioral: high intensity functional exercise
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Official Title: Evaluation of an Intervention Program Targeted at Improving Balance and Functional Skills After Stroke - a Randomized Controlled Study

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Umeå University:

Primary Outcome Measures:
  • Improvement in balance [ Time Frame: post, 3 & 6 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Reduced falls [ Time Frame: post, 3 & 6 months ] [ Designated as safety issue: Yes ]
  • Improved self-efficacy [ Time Frame: post, 3 & 6 months ] [ Designated as safety issue: Yes ]
  • Improved ADL [ Time Frame: post, 3 & 6 months ] [ Designated as safety issue: Yes ]
  • Improved walking ability [ Time Frame: post, 3 & 6 months ] [ Designated as safety issue: Yes ]

Enrollment: 34
Study Start Date: September 2006
Study Completion Date: April 2008
Primary Completion Date: April 2008 (Final data collection date for primary outcome measure)
Intervention Details:
    Behavioral: high intensity functional exercise
    high intensity functional exercise
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.

  Eligibility

Ages Eligible for Study:   55 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

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
Study First Received: September 15, 2006
Last Updated: October 27, 2008
Health Authority: Sweden: Regional Ethical Review Board

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

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

ClinicalTrials.gov processed this record on May 23, 2013