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Does Intensive Task Specific Training Improve Balance After Acute Stroke?

Primary Purpose

Cerebrovascular Accident

Status

Completed

Phase

Not Applicable

Locations

Norway

Study Type

Interventional

Intervention

Physical therapy technique and exercises

Sponsored by

Norwegian University of Science and Technology

About this trial

This is an interventional treatment trial for Cerebrovascular Accident focused on measuring Cerebrovascular Accident, Physical Therapy Techniques, Musculoskeletal Equilibrium, Rehabilitation

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Norwegian University of Science and Technology

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

A

B

Arm Description

Intensive task specific balance training

Traditional physical therapy

Outcomes

Primary Outcome Measures

The Berg Balance Scale

Secondary Outcome Measures

Mini Mental State Examination

Scandinavian Stroke Scale

Motor Assessment Scale

Timed Up and Go

Step Test

Walking speed

Barthel Index

Modified Rankin Scale

Fall Efficacy Scale

Stroke Impact Scale

Full Information

NCT ID

First Posted

September 15, 2005

Last Updated

October 17, 2011

Sponsor

Norwegian University of Science and Technology

Collaborators

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

1. Study Identification

Unique Protocol Identification Number

NCT00184431

Brief Title

Does Intensive Task Specific Training Improve Balance After Acute Stroke?

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

October 2011

Overall Recruitment Status

Completed

Study Start Date

April 2004 (undefined)

Primary Completion Date

April 2008 (Actual)

Study Completion Date

April 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Norwegian University of Science and Technology

Collaborators

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

4. Oversight

Data Monitoring Committee

No

5. Study Description

Brief 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Cerebrovascular Accident

Keywords

Cerebrovascular Accident, Physical Therapy Techniques, Musculoskeletal Equilibrium, Rehabilitation

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Participant

Allocation

Randomized

Enrollment

62 (Actual)

8. Arms, Groups, and Interventions

Arm Title

A

Arm Type

Experimental

Arm Description

Intensive task specific balance training

Arm Title

B

Arm Type

Active Comparator

Arm Description

Traditional physical therapy

Intervention Type

Behavioral

Intervention Name(s)

Physical therapy technique and exercises

Intervention Description

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 Outcome Measure Information:

Title

The Berg Balance Scale

Time Frame

Inclusion, four weeks follow-up, twelve weeks follow-up and six months follow-up

Secondary Outcome Measure Information:

Title

Mini Mental State Examination

Time Frame

Inclusion

Title

Scandinavian Stroke Scale

Time Frame

Inclusion

Title

Motor Assessment Scale

Time Frame

Inclusion, four weeks follow-up, twelve weeks follow-up, six months follow-up

Title

Timed Up and Go

Time Frame

Inclusion, four weeks follow-up, twelve weeks follow-up, six months follow-up

Title

Step Test

Time Frame

Inclusion, four weeks follow-up, twelve weeks follow-up, six months follow-up

Title

Walking speed

Time Frame

Inclusion, four weeks follow-up, twelve weeks follow-up, six months follow-up

Title

Barthel Index

Time Frame

Inclusion, four weeks follow-up, twelve weeks follow-up, six months follow-up

Title

Modified Rankin Scale

Time Frame

Inclusion, four weeks follow-up, twelve weeks follow-up, six months follow-up

Title

Fall Efficacy Scale

Time Frame

Inclusion, four weeks follow-up, twelve weeks follow-up, six months follow-up

Title

Stroke Impact Scale

Time Frame

Inclusion, four weeks follow-up, twelve weeks follow-up, six months follow-up

10. Eligibility

Sex

All

Accepts Healthy Volunteers

No

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Bent Indredavik, assoc-prof

Organizational Affiliation

Department of Neuroscience, Faculty of Medicine, Norwegian university of Science and Technology

Official's Role

Study Chair

Facility Information:

Facility Name

Norwegian University of Science and Technology

City

Trondheim

ZIP/Postal Code

7004

Country

Norway

12. IPD Sharing Statement

Citations:

PubMed Identifier

20558830

Citation

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.

Results Reference

result

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Does Intensive Task Specific Training Improve Balance After Acute Stroke?

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