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CompletedNCT00377689Updated Oct 29, 2008

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

A Phase 2 interventional study of high intensity functional exercise in Cerebrovascular Accident and Musculoskeletal Equilibrium, sponsored by Umeå University. Completed at 1 site in Sweden. Open to participants aged 55 Years and older. Per ClinicalTrials.gov, last updated 2008-10-29.

Sponsored by Umeå University · Phase 2 and Interventional

Phase
Phase 2
Study type
Interventional
Enrollment
34
Allocation
Randomized
Ages
55 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Cerebrovascular Accident
  • Musculoskeletal Equilibrium

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Keywords

  • Accidental falls
  • Cerebrovascular accident
  • Balance
  • ADL
  • Self efficacy
  • Quality of Life
  • Gait parameters
03

In context

Stroke

7,286 studies on the registry are indexed under Stroke; 2,007 are open to participants now.

This study's enrollment of 34 is below the median of 50 across 5,369 interventional studies indexed under Stroke.

Browse Stroke studies →

Lead sponsor

Umeå University is the lead sponsor of 263 studies on the registry; 60 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
55 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

Exclusion Criteria:

  • TIA
  • independent in walking outdoors
  • serious visual impairment
  • serious hearing impairment
  • long distance to intervention station
05

Study design

Phase
Phase 2
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
34 participants (actual)

Interventions

  • Behavioralhigh intensity functional exercise

    high intensity functional exercise

06

What researchers measure

Primary outcomes

  1. Improvement in balance

    Time frame: post, 3 & 6 months

Secondary outcomes

  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

07

Study locations

1 site
  • Umeå University, department of Community science and rehabilitation
    Umeå, 90137, Sweden
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 29, 2008, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00377689
Lead 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
First posted
Sep 18, 2006
Start date
Sep 2006
Primary completion
Apr 2008
Completion
Apr 2008
Last update
Oct 29, 2008

Study contacts

Eva Holmgren, PhD student
principal investigator · Umeå University & The Vårdal Institute
Per Wester, MD Professor
study chair · Umeå University
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Oct 2008. You cannot join it, but the record below documents what was studied.

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