Trial record 11 of 59 for:
"balance impairment" OR "balance training" | Open Studies
Body Awareness Therapy for People With Stroke
This study is currently recruiting participants.
Verified June 2012 by Örebro County Council
Sponsor:
Örebro County Council
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
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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:
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 May 16, 2013