Does Intensive Task Specific Training Improve Balance After Acute Stroke?

This study has been completed.
Sponsor:
Collaborators:
St. Olavs Hospital
Norwegian Fund for Postgraduate Training in Physiotherapy
Information provided by (Responsible Party):
Norwegian University of Science and Technology
ClinicalTrials.gov Identifier:
NCT00184431
First received: September 15, 2005
Last updated: October 17, 2011
Last verified: October 2011
  Purpose

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.


Condition Intervention
Cerebrovascular Accident
Behavioral: Physical therapy technique and exercises

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: A Randomized Controlled Trial Comparing Intensive Task Specific Training With Traditional Follow up Care After Discharge From a Stroke Unit.

Further study details as provided by Norwegian University of Science and Technology:

Primary Outcome Measures:
  • The Berg Balance Scale [ Time Frame: Inclusion, four weeks follow-up, twelve weeks follow-up and six months follow-up ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Mini Mental State Examination [ Time Frame: Inclusion ] [ Designated as safety issue: No ]
  • Scandinavian Stroke Scale [ Time Frame: Inclusion ] [ Designated as safety issue: No ]
  • Motor Assessment Scale [ Time Frame: Inclusion, four weeks follow-up, twelve weeks follow-up, six months follow-up ] [ Designated as safety issue: No ]
  • Timed Up and Go [ Time Frame: Inclusion, four weeks follow-up, twelve weeks follow-up, six months follow-up ] [ Designated as safety issue: No ]
  • Step Test [ Time Frame: Inclusion, four weeks follow-up, twelve weeks follow-up, six months follow-up ] [ Designated as safety issue: No ]
  • Walking speed [ Time Frame: Inclusion, four weeks follow-up, twelve weeks follow-up, six months follow-up ] [ Designated as safety issue: No ]
  • Barthel Index [ Time Frame: Inclusion, four weeks follow-up, twelve weeks follow-up, six months follow-up ] [ Designated as safety issue: No ]
  • Modified Rankin Scale [ Time Frame: Inclusion, four weeks follow-up, twelve weeks follow-up, six months follow-up ] [ Designated as safety issue: No ]
  • Fall Efficacy Scale [ Time Frame: Inclusion, four weeks follow-up, twelve weeks follow-up, six months follow-up ] [ Designated as safety issue: No ]
  • Stroke Impact Scale [ Time Frame: Inclusion, four weeks follow-up, twelve weeks follow-up, six months follow-up ] [ Designated as safety issue: No ]

Enrollment: 62
Study Start Date: April 2004
Study Completion Date: April 2008
Primary Completion Date: April 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00184431

Locations
Norway
Norwegian University of Science and Technology
Trondheim, Norway, 7004
Sponsors and Collaborators
Norwegian University of Science and Technology
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
  More Information

Publications:
Responsible Party: Norwegian University of Science and Technology
ClinicalTrials.gov Identifier: NCT00184431     History of Changes
Other Study ID Numbers: SU01-ISM-NTNU
Study First Received: September 15, 2005
Last Updated: October 17, 2011
Health Authority: Norway: Norwegian Social Science Data Services

Keywords provided by Norwegian University of Science and Technology:
Cerebrovascular Accident
Physical Therapy Techniques
Musculoskeletal Equilibrium
Rehabilitation

Additional relevant MeSH terms:
Cerebral Infarction
Stroke
Brain Infarction
Brain Ischemia
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on October 19, 2014