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

Cerebrovascular Accident Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00377689
• Other study ID #: Dnr 04-022
• Status: Completed
• Phase: Phase 2
• First received: September 15, 2006
• Last updated: October 27, 2008
• Start date: September 2006
• Est. completion date: April 2008

Study information

• Verified date: October 2008
• Source: Umeå University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Sweden: Regional Ethical Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 34
• Est. completion date: April 2008
• Est. primary completion date: April 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 55 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor)

Related Conditions & MeSH terms

• Cerebrovascular Accident
• Musculoskeletal Equilibrium
• Stroke

Intervention

Behavioral:
• high intensity functional exercise
high intensity functional exercise

Locations

Country	Name	City	State
Sweden	Umeå University, department of Community science and rehabilitation	Umeå

Sponsors (5)

Lead Sponsor	Collaborator
Umeå University	Erik & AnnMarie Detlofs Foundation, The Northern County Councils Regional Federation, The Swedish National Stroke society, Vardalinstitutet The Swedish Institute for Health Sciences

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Improvement in balance		post, 3 & 6 months	Yes
Secondary	Reduced falls		post, 3 & 6 months	Yes
Secondary	Improved self-efficacy		post, 3 & 6 months	Yes
Secondary	Improved ADL		post, 3 & 6 months	Yes
Secondary	Improved walking ability		post, 3 & 6 months	Yes