Does Intensive Task Specific Training Improve Balance After Acute Stroke?

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

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.

Study Overview

• Status: Completed
• Conditions: Cerebrovascular Accident
• Intervention / Treatment: Behavioral: Physical therapy technique and exercises

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 62
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Norway
  • Trondheim, Norway, 7004
    • Norwegian University of Science and Technology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: A; Intensive task specific balance training	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.
Active Comparator: B; Traditional physical therapy	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
The Berg Balance Scale	Inclusion, four weeks follow-up, twelve weeks follow-up and six months follow-up

Secondary Outcome Measures

Outcome Measure	Time Frame
Mini Mental State Examination	Inclusion
Scandinavian Stroke Scale	Inclusion
Motor Assessment Scale	Inclusion, four weeks follow-up, twelve weeks follow-up, six months follow-up
Timed Up and Go	Inclusion, four weeks follow-up, twelve weeks follow-up, six months follow-up
Step Test	Inclusion, four weeks follow-up, twelve weeks follow-up, six months follow-up
Walking speed	Inclusion, four weeks follow-up, twelve weeks follow-up, six months follow-up
Barthel Index	Inclusion, four weeks follow-up, twelve weeks follow-up, six months follow-up
Modified Rankin Scale	Inclusion, four weeks follow-up, twelve weeks follow-up, six months follow-up
Fall Efficacy Scale	Inclusion, four weeks follow-up, twelve weeks follow-up, six months follow-up
Stroke Impact Scale	Inclusion, four weeks follow-up, twelve weeks follow-up, six months follow-up

Collaborators and Investigators

• Sponsor: Norwegian University of Science and Technology
• Collaborators: St. Olavs Hospital; Norwegian Fund for Postgraduate Training in Physiotherapy
• Investigators: Study Chair: Bent Indredavik, assoc-prof, Department of Neuroscience, Faculty of Medicine, Norwegian university of Science and Technology

Publications and helpful links

General Publications

• Askim T, Morkved 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 Aug;41(8):1697-703. doi: 10.1161/STROKEAHA.110.584284. Epub 2010 Jun 17.

Study record dates

Study Major Dates

• Study Start: April 1, 2004
• Primary Completion (Actual): April 1, 2008
• Study Completion (Actual): April 1, 2008

Study Registration Dates

• First Submitted: September 15, 2005
• First Submitted That Met QC Criteria: September 15, 2005
• First Posted (Estimate): September 16, 2005

Study Record Updates

• Last Update Posted (Estimate): October 18, 2011
• Last Update Submitted That Met QC Criteria: October 17, 2011
• Last Verified: October 1, 2011

More Information

Terms related to this study

• Keywords: Rehabilitation; Cerebrovascular Accident; Physical Therapy Techniques; Musculoskeletal Equilibrium
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Stroke
• Other Study ID Numbers: SU01-ISM-NTNU