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Completed

NCT Number: NCT00184431

Does Intensive Task Specific Training Improve Balance After Acute Stroke?

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.

Completed

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Key information

Conditions

Cerebrovascular Accident Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Nervous System Diseases Stroke Vascular Diseases

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Norwegian University of Science and Technology

Trondheim, 7004, Norway

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Physical therapy technique and exercises

Behavioral

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.

Primary outcomes

  1. The Berg Balance Scale

    Time frame: Inclusion, four weeks follow-up, twelve weeks follow-up and six months follow-up

Secondary outcomes

  1. Mini Mental State Examination

    Time frame: Inclusion

  2. Scandinavian Stroke Scale

    Time frame: Inclusion

  3. Motor Assessment Scale

    Time frame: Inclusion, four weeks follow-up, twelve weeks follow-up, six months follow-up

  4. Timed Up and Go

    Time frame: Inclusion, four weeks follow-up, twelve weeks follow-up, six months follow-up

  5. Step Test

    Time frame: Inclusion, four weeks follow-up, twelve weeks follow-up, six months follow-up

  6. Walking speed

    Time frame: Inclusion, four weeks follow-up, twelve weeks follow-up, six months follow-up

  7. Barthel Index

    Time frame: Inclusion, four weeks follow-up, twelve weeks follow-up, six months follow-up

  8. Modified Rankin Scale

    Time frame: Inclusion, four weeks follow-up, twelve weeks follow-up, six months follow-up

  9. Fall Efficacy Scale

    Time frame: Inclusion, four weeks follow-up, twelve weeks follow-up, six months follow-up

  10. Stroke Impact Scale

    Time frame: Inclusion, four weeks follow-up, twelve weeks follow-up, six months follow-up

Sponsors and collaborators

Lead sponsor

Norwegian University of Science and Technology

Other

Collaborators

  • Norwegian Fund for Postgraduate Training in Physiotherapy
  • St. Olavs Hospital

Registry information

Official study title

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

Important dates

Study start
2004
Primary completion
2008
Study completion
2008
First posted
Sep 16, 2005
Registry last updated
Oct 18, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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