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Body Awareness Therapy for People With Stroke

Primary Purpose

Stroke

Status
Completed
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
Balance training using Body awareness therapy
Sponsored by
Örebro County Council
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke focused on measuring stroke, postural control, body awareness therapy

Eligibility Criteria

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

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.

Sites / Locations

  • Primary Health Care Centres

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Body awareness therapy

Control

Arm Description

Outcomes

Primary Outcome Measures

Bergs Balance Scale
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.

Secondary Outcome Measures

Timed Up and Go Test
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.
Activities-specific Balance Confidence Scale
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.

Full Information

First Posted
April 16, 2012
Last Updated
May 7, 2018
Sponsor
Örebro County Council
Collaborators
Norrbacka-Eugenia Foundation
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1. Study Identification

Unique Protocol Identification Number
NCT01613339
Brief Title
Body Awareness Therapy for People With Stroke
Official Title
Body Awareness Therapy for People With Stroke
Study Type
Interventional

2. Study Status

Record Verification Date
May 2018
Overall Recruitment Status
Completed
Study Start Date
October 2011 (undefined)
Primary Completion Date
February 2013 (Actual)
Study Completion Date
February 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Örebro County Council
Collaborators
Norrbacka-Eugenia Foundation

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke
Keywords
stroke, postural control, body awareness therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
46 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Body awareness therapy
Arm Type
Experimental
Arm Title
Control
Arm Type
No Intervention
Intervention Type
Other
Intervention Name(s)
Balance training using Body awareness therapy
Intervention Description
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.
Primary Outcome Measure Information:
Title
Bergs Balance Scale
Description
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.
Time Frame
Change from baseline in Bergs balance scale at 9 weeks
Secondary Outcome Measure Information:
Title
Timed Up and Go Test
Description
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.
Time Frame
Change from baseline in Timed Up and Go test at 9 weeks
Title
Activities-specific Balance Confidence Scale
Description
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.
Time Frame
Change from baseline in Activities-specific Balance confidence scale at 9 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mialinn Arvidsson Lindvall, RPT, MSc
Organizational Affiliation
Family Medicine Research Centre, Örebro county council
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Anette Forsberg, PhD
Organizational Affiliation
Family Medicine Research Centre, Örebro county council
Official's Role
Study Chair
Facility Information:
Facility Name
Primary Health Care Centres
City
Örebro
Country
Sweden

12. IPD Sharing Statement

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Body Awareness Therapy for People With Stroke

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