- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01613339
Body Awareness Therapy for People With Stroke
May 7, 2018 updated by: Anette Forsberg, PhD, Örebro County Council
Affected balance capacity is common after a stroke due to paresis and sensory disturbances.
The affected balance capacity may cause walking disturbances, falls and decreased mobility.
Balance may be improved by physical therapy.
A possible method for balance training is body awareness therapy, that was introduced in Sweden by Jacques Dropsy and Gertrud Roxendal.
Earlier body awareness therapy was mostly used in psychiatric care but in the recent years the method has been used for people with long-tern pain, amputations and multiple sclerosis.
Body awareness therapy includes exercises in lying, sitting and standing.
Focus of the exercises are awareness of one´s movement behaviour, breathing patterns, resources and limitations.
Postural control is an essential part in the exercises.
Body awareness therapy could be used for people with stroke as a way to improve postural control.
The aim of this study is to investigate if balance training using body awareness therapy can improve balance and walking in people after stroke.
The interventions consists of body awareness therapy once a week for 8 weeks.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
46
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Örebro, Sweden
- Primary Health Care Centres
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Diagnosed stroke more than 6 months ago. Walking capacity of 100 meter with or without assistive device.
Exclusion Criteria:
- Medical or cognitive impairment that prohibits participating in the intervention.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
No Intervention: Control
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Experimental: Body awareness therapy
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Once a week, 1 hour for 8 weeks.Body awareness training may be performed by physiotherapist.
Exercises are performed in standing, sitting and lying.
Example of exercises are weight-balancing in standing and relaxation exercises.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Bergs Balance Scale
Time Frame: Change from baseline in Bergs balance scale at 9 weeks
|
Test of functional balance. Includes 14 items all graded 0-4 where 0 indicate larger impairment. Total score is used here, maximum 56 and minimum 0. The Berg balance scale was developed for older patients but is a much used meausure of dynamic and static functional balance. |
Change from baseline in Bergs balance scale at 9 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Timed Up and Go Test
Time Frame: Change from baseline in Timed Up and Go test at 9 weeks
|
test of functional mobility.
Time is taken in seconds.
The participants sits on a chair with armrests are then asked to rise, walk 3 meters, turn and walk back and sit down.
|
Change from baseline in Timed Up and Go test at 9 weeks
|
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Activities-specific Balance Confidence Scale
Time Frame: Change from baseline in Activities-specific Balance confidence scale at 9 weeks
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16 item questionnaire that investigates balance self-efficacy.
Each items is a question; How secure are you that you will not fall when you...sweep the floor?
The participant are asked to grade his/hers feeling of secutiry from 0, 10, 20 and so on up to 100.
0 is regarded low balance self-efficacy.
The item responses are summed and divided by 16.
|
Change from baseline in Activities-specific Balance confidence scale at 9 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Mialinn Arvidsson Lindvall, RPT, MSc, Family Medicine Research Centre, Örebro County Council
- Study Chair: Anette Forsberg, PhD, Family Medicine Research Centre, Örebro County Council
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
October 1, 2011
Primary Completion (Actual)
February 1, 2013
Study Completion (Actual)
February 1, 2013
Study Registration Dates
First Submitted
April 16, 2012
First Submitted That Met QC Criteria
June 4, 2012
First Posted (Estimate)
June 7, 2012
Study Record Updates
Last Update Posted (Actual)
June 28, 2018
Last Update Submitted That Met QC Criteria
May 7, 2018
Last Verified
May 1, 2018
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- AF-1-2011
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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