- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00377689
Evaluation of an Intervention Program Targeted at Improving Balance and Functional Skills After Stroke
Evaluation of an Intervention Program Targeted at Improving Balance and Functional Skills After Stroke - a Randomized Controlled Study
Study Overview
Status
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
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
-
-
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Umeå, Sweden, 90137
- Umeå University, department of Community science and rehabilitation
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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
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
Sponsor
Collaborators
Investigators
- Principal Investigator: Eva Holmgren, PhD student, Umeå University & The Vårdal Institute
- Study Chair: Per Wester, MD Professor, Umea University
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
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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