StrokeNCT01613339
Body Awareness Therapy for People With Stroke
A study testing Balance training using Body awareness therapy in people with Stroke, run by Örebro County Council at 1 site in Sweden.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke
- What is being tested?
- Balance training using Body awareness therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 1 siteSweden
- Study dates
- Oct 2011to Feb 2013
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosed stroke more than 6 months ago. Walking capacity of 100 meter with or without assistive device.
Who cannot join
- Medical or cognitive impairment that prohibits participating in the intervention.
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Stroke
- Being tested
- Balance training using Body awareness therapy
- Keywords
- stroke, postural control, body awareness therapy
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Balance training using Body awareness therapyOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Body awareness therapy | Experimental | Not described Receives: Other: Balance training using Body awareness therapy |
| Control | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Change from baseline in Bergs balance scale at 9 weeks
Secondary outcomes (2)
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.
Measured: Change from baseline in Timed Up and Go test at 9 weeks
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.
Measured: Change from baseline in Activities-specific Balance confidence scale at 9 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2012 (estimated)
- Study startOct 2011
- Primary completionFeb 2013
- Study completionFeb 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- Örebro County Council
- Sponsor type
- Other government
- Collaborators
- Norrbacka-Eugenia Foundation
- Responsible party
- Principal investigator, Anette Forsberg, PhD, Örebro County Council
- Investigators
- Mialinn Arvidsson Lindvall, RPT, MSc, Principal investigator, Family Medicine Research Centre, Örebro county councilAnette Forsberg, PhD, Study chair, Family Medicine Research Centre, Örebro county council
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01613339
- Sponsor's protocol ID
- AF-1-2011
- Status last verified
- May 2018
- First submitted
- 16 Apr 2012
- Last updated
- 28 Jun 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Body Awareness Therapy for People With Stroke
- ClinicalTrials.gov ID
- NCT01613339
- Acronym / sponsor ID
- AF-1-2011
- Conditions
- Stroke
- Keywords
- stroke, postural control, body awareness therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- Örebro County CouncilOther government
- Collaborators
- Norrbacka-Eugenia Foundation
- Study start
- Oct 2011
- Primary completion
- Feb 2013 (actual)
- Study completion
- Feb 2013 (actual)
- First posted
- 7 Jun 2012 (estimated)
- Results
- Posted 30 Dec 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Body awareness therapy | Experimental | Other: Balance training using Body awareness therapy |
| Control | No intervention | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Diagnosed stroke more than 6 months ago. Walking capacity of 100 meter with or without assistive device.
Key exclusion criteria (1 listed)
- Medical or cognitive impairment that prohibits participating in the intervention.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Balance training using Body awareness therapyOnce 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. | Other | Body awareness therapy |
Primary outcome
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.
2 secondary outcomes
Timed Up and Go Test
Time frame: Change from baseline in Timed Up and Go test at 9 weeks
Activities-specific Balance Confidence Scale
Time frame: Change from baseline in Activities-specific Balance confidence scale at 9 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jun 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Stroke
Active, not recruitingObservational study
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Stroke and Systemic Embolism Prevention in Adult Participants With Atrial Fibrillation
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The Effects of an Augmented Reality-Based Mirror Therapy System in Patients With Stroke
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A Pivotal Study Evaluating Safety and Effectiveness of Adaptative Tip Catheter in Patients With Acute Ischemic Stroke
Ischemic Stroke
RecruitingObservational study
Role of EEG in Differentiation Between Ischemic and Hemorrhagic Stroke
Acute Ischemic Stroke, Acute Haemorrhagic Stroke
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mialinn Arvidsson Lindvall, RPT, MSc principal investigator
Family Medicine Research Centre, Örebro county council
Anette Forsberg, PhD study chair
Family Medicine Research Centre, Örebro county council
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Balance training using Body awareness therapy in people with Stroke, run by Örebro County Council at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 30 Dec 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Bergs Balance Scale (time frame: Change from baseline in Bergs balance scale at 9 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jun 2018.