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Body Awareness Therapy for People With Stroke

This study is currently recruiting participants.
Verified June 2012 by Örebro County Council
Sponsor:
Collaborators:
Norrbacka-Eugenia Foundation
The Swedish Stroke Association
Information provided by (Responsible Party):
Anette Forsberg, PhD, Örebro County Council
ClinicalTrials.gov Identifier:
NCT01613339
First received: April 16, 2012
Last updated: June 8, 2012
Last verified: June 2012
History of Changes
  Purpose

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.


Condition Intervention
Stroke
 Other: Balance training using Body awareness therapy

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Body Awareness Therapy for People With Stroke

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Örebro County Council:

Primary Outcome Measures:
  • Timed Up and Go test [ Time Frame: Change from baseline in Timed Up and Go test at 8 weeks ] [ Designated as safety issue: No ]
    test of functional mobility


Secondary Outcome Measures:
  • Timed Chair stands [ Time Frame: Change from baseline in Timed Chair stands at 8 weeks ] [ Designated as safety issue: No ]
    Test of fucntional leg strength, rising from a chair 10 times.

  • Bergs balance scale [ Time Frame: Change from baseline in Bergs balance scale at 8 weeks ] [ Designated as safety issue: No ]
    Test of functional balance

  • 6 minute walking test [ Time Frame: Change from baseline in 6 minute walking test at 8 weeks ] [ Designated as safety issue: No ]
    The distance covered during 6 minutes walking

  • Activities-specific Balance Confidence scale [ Time Frame: Change from baseline in Activities-specific Balance confidence scale at 8 weeks ] [ Designated as safety issue: No ]
    16 item questionnaire that investigates balance self-efficacy

  • SF-36 [ Time Frame: Change from baseline in SF-36 at 8 weeks ] [ Designated as safety issue: No ]
    A generic measure of health-related quality of life

  • Timed Up and Go test [ Time Frame: Change from baseline in Timed Up and Go test at 14 weeks ] [ Designated as safety issue: No ]
    test of functional mobility. Follow-up assessment.

  • Timed Chair stands [ Time Frame: Change from baseline in Timed chair stands at 14 weeks ] [ Designated as safety issue: No ]
    test of functional leg strength. Follow-up assessment.

  • Bergs balance scale [ Time Frame: Change from Baseline in Bergs balance scale at 14 weeks ] [ Designated as safety issue: No ]
    Test of fucntional balance. Follow-up assessment.

  • 6 minute walking test [ Time Frame: Change from baseline in 6 minute walking test at 14 weeks ] [ Designated as safety issue: No ]
    Follow-up assessment of the distance covered during 6 minutes walking

  • Activities-specific balance scale [ Time Frame: Change from baseline in Activities-specific balance scale at 14 weeks ] [ Designated as safety issue: No ]
    Follow-up assessment of self-reported confidence of performing activities

  • SF-36 [ Time Frame: Change from baseline in SF-36 at 14 weeks. ] [ Designated as safety issue: No ]
    Follow-up assessment of self-reported quality of life


Estimated Enrollment: 40
Study Start Date: October 2011
Estimated Study Completion Date: March 2013
Estimated Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Body awareness therapy Other: Balance training using Body awareness therapy
Once a week, 1 hour for 8 weeks.Body awareness training may be performed by physiotherapist. Exercises are performed in standing, sitting and lying. Exemple of exercies are weight-balancing in standing and relaxation exercises.
No Intervention: Control

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01613339

Contacts
Contact: Anette Forsberg, PhD +46-19-602 5788 anette.forsberg@orebroll.se

Locations
Sweden
Primary Health Care Centres Recruiting
Örebro, Sweden
Principal Investigator: Mialinn Arvidsson Lindvall, RPT            
Sponsors and Collaborators
Örebro County Council
Norrbacka-Eugenia Foundation
The Swedish Stroke Association
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
  More Information

No publications provided

Responsible Party: Anette Forsberg, PhD, Researcher, RPT, Örebro County Council
ClinicalTrials.gov Identifier: NCT01613339     History of Changes
Other Study ID Numbers: AF-1-2011
Study First Received: April 16, 2012
Last Updated: June 8, 2012
Health Authority: Sweden: Regional Ethical Review Board

Keywords provided by Örebro County Council:
stroke
postural control
body awareness therapy

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

ClinicalTrials.gov processed this record on June 18, 2013