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Clinical Trials/NCT00377689
NCT00377689CompletedPhase 2

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

Umeå University1 site in 1 country34 target enrollmentStarted: September 1, 2006Last updated:
Conditions

Trial Snapshot

Phase
Phase 2
Status
Completed
Enrollment
34
Locations
1
Primary Endpoint
Improvement in balance

Study Overview

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.

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
Allocation
Randomized
Intervention Model
Parallel
Masking
Double (Participant, Outcomes Assessor)

Eligibility Criteria

Ages
55 Years to — (Adult, Older Adult)
Sex
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

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

Outcomes

Primary Outcomes

Improvement in balance

Time Frame: post, 3 & 6 months

Secondary Outcomes

  • Reduced falls(post, 3 & 6 months)
  • Improved self-efficacy(post, 3 & 6 months)
  • Improved ADL(post, 3 & 6 months)
  • Improved walking ability(post, 3 & 6 months)

Investigators

Sponsor Class
Other

Study Sites (1)

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