Does Intensive Task Specific Training Improve Balance After Acute Stroke?

Cerebrovascular Accident Clinical Trial

Official title:

A Randomized Controlled Trial Comparing Intensive Task Specific Training With Traditional Follow up Care After Discharge From a Stroke Unit.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00184431
• Other study ID #: SU01-ISM-NTNU
• Status: Completed
• Phase: N/A
• First received: September 15, 2005
• Last updated: October 17, 2011
• Start date: April 2004
• Est. completion date: April 2008

Study information

• Verified date: October 2011
• Source: Norwegian University of Science and Technology
• Contact: n/a
• Is FDA regulated: No
• Health authority: Norway: Norwegian Social Science Data Services
• Study type: Interventional

Clinical Trial Summary

The aim of this study is to investigate whether additional task specific physiotherapy treatment and a self administrated home training program results in better balance compared to traditional follow up care.

Description:

Increased risk of falling is a major problem after stroke and impaired balance is one of the main reasons for falling. Early and intensive physiotherapy seems to be beneficial for functional outcome after stroke although it is still unknown whether one specific physiotherapy technique is better than another.

Comparison: Traditional follow up care by the community health care system with additional task specific physiotherapy three times a week and a daily self administrated home training program compared to traditional follow up care by the community health care system.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 62
• Est. completion date: April 2008
• Est. primary completion date: April 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Admitted to the stroke unit with a diagnosis of stroke

• Living in the city of Trondheim

• Included 4 - 14 days after first sign of symptoms

• Modified Rankin Scale > 3 before admission to hospital

• Scandinavian Stroke Scale (SSS) less than 58 points and more than 14 points

• SSS leg item less than 6 points or SSS movement item less than 12 points

• Discharged to home or a rehabilitation clinic

• Mini Mental State Examination Score more than 20 points

• Able and willing to provide informed consent

Exclusion Criteria:

• Seriously heart- and lung-diseases

• Other diseases which makes it difficult to evaluate the function

• Already included in the trial

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cerebrovascular Accident
• Stroke

Intervention

Behavioral:
• Physical therapy technique and exercises
The experimental group receives task specific physical therapy three times a week for the first four weeks after discharge from hospital and one session pr week for the next eight weeks in addition to ordinary physical therapy The active comparator group receives only ordinary physical therapy during this period.

Locations

Country	Name	City	State
Norway	Norwegian University of Science and Technology	Trondheim

Sponsors (3)

Lead Sponsor	Collaborator
Norwegian University of Science and Technology	Norwegian Fund for Postgraduate Training in Physiotherapy, St. Olavs Hospital

Country where clinical trial is conducted

Norway, 

References & Publications (1)

Askim T, Mørkved S, Engen A, Roos K, Aas T, Indredavik B. Effects of a community-based intensive motor training program combined with early supported discharge after treatment in a comprehensive stroke unit: a randomized, controlled trial. Stroke. 2010 Au — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The Berg Balance Scale		Inclusion, four weeks follow-up, twelve weeks follow-up and six months follow-up	No
Secondary	Mini Mental State Examination		Inclusion	No
Secondary	Scandinavian Stroke Scale		Inclusion	No
Secondary	Motor Assessment Scale		Inclusion, four weeks follow-up, twelve weeks follow-up, six months follow-up	No
Secondary	Timed Up and Go		Inclusion, four weeks follow-up, twelve weeks follow-up, six months follow-up	No
Secondary	Step Test		Inclusion, four weeks follow-up, twelve weeks follow-up, six months follow-up	No
Secondary	Walking speed		Inclusion, four weeks follow-up, twelve weeks follow-up, six months follow-up	No
Secondary	Barthel Index		Inclusion, four weeks follow-up, twelve weeks follow-up, six months follow-up	No
Secondary	Modified Rankin Scale		Inclusion, four weeks follow-up, twelve weeks follow-up, six months follow-up	No
Secondary	Fall Efficacy Scale		Inclusion, four weeks follow-up, twelve weeks follow-up, six months follow-up	No
Secondary	Stroke Impact Scale		Inclusion, four weeks follow-up, twelve weeks follow-up, six months follow-up	No