AutismNCT03723876
Basic Body Awareness Therapy for Persons With Autism
A study testing Body awareness therapy in people with Autism, run by Lund University at 2 sites in Sweden.
Trial summary
Autism is a diagnosis with certain criteria, especially social and communicative disabilities. Several body functions may be affected to create these disabilities, such as lack of ability to understand that other people think or feel differently than the person with autism, difficulty to experience bodily signals or… Read more about this study
- Who is it for?
- Ages 15 to 30 years
- Conditions the study is for
- Autism
- What is being tested?
- Body awareness therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 57 participants
- Where
- 2 sitesSweden
- Study dates
- 1 May 2018to 15 Jun 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 15 to 30 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- diagnosed with an autism diagnosis (F84* in ICD-10)
- 15-30 years
- accepted for care at habilitation unit
Who cannot join
- diagnosed with intellectual disability (F70*-F73*, F78*-F79* in ICD-10)
- medium or severe depression
- major problems with country´s native language
Trial locations and contacts
2 sites in 1 country.
Sweden2 sites
Habiliteringen Vastra Gotalandsregionen
Skövde, Västra Götaland County, 54150
Vuxenhabiliteringen
Vaxjo, Kronoberg County
About this study
Official title: Basic Body Awareness Therapy for Persons With Autism. A Pragmatic Randomized Controlled Study
Autism is a diagnosis with certain criteria, especially social and communicative disabilities. Several body functions may be affected to create these disabilities, such as lack of ability to understand that other people think or feel differently than the person with autism, difficulty to experience bodily signals or deviant function of sensory modalities.
Several theories describe that our physical, physiological, psychological and existential being can not be separated from each other. The combination of described difficulties in autism makes the perception of the surrounding world or the people within it difficult to understand or interpret, i.e., lack of a sense of coherence. The inner experience of the person as well as the expression of his/her movement qualities will be the effects.
Read more
There are physiotherapeutic intervention techniques of body awareness, with the purpose to increase the connection to the body and to work with more functional movements. Instead of working with improving the well-being by cognitive top-down techniques, body awareness techniques work bottom-up.
The hypothesis is that an intervention with body awareness therapy will increase the possibility for persons with autism to improve movement quality, and increase contact with bodily signals. It will give a better chance to understand and interpret the world and people in different context, conquering a sense of coherence.
The study include at least 40 participants with autism randomized to two groups: 1.) intervention once a week for 12 weeks and 2. ) a control group (who will be invited to the therapy after ending study participation). They will be recruited from patient records in habilitation care. The criteria are: having autism, being 15-30 years, not having an intellectual impairment and not having a severe depression. The participants are to have been assessed with the standardized "Basic Body Awareness Scale Movement Quality and Experience", BAS MQ-E, and been found to being relevant participants for body awareness intervention in regard to the expressed individual health problem.
Two assessments will be used. The primary one addresses each participants´s individual health problem, using a visual 11-graded scale (NRS), grading the present experience of the health problem. The secondary one is BAS MQ-E. The assessments will be administered as follows: i) prior to; NRS + BAS MQ-E, ii) after 7 occasions; NRS and iii) maximum 2 months after intervention; NRS + BAS MQ-E.
Read the detailed description
Introduction Movement quality is a concept that describes how movements are performed in space, time and amount of energy. When the quality is good, the movement is perceived as unrestricted and gives a sense of freedom, physically and mentally. Movement quality and body awareness are dependent on each other. Body awareness is the ability to be consciously present and interpret signals from your own body. A physiotherapeutic treatment method that describes how movement quality and body awareness interact on a deeper level is Basic Body Awareness Therapy (BBAT).
The purpose of BBAT is to raise physical and mental awareness by strengthening the interplay between sensory impressions and motor ability, gaining knowledge of movement patterns and habits that are not functional. Man's ability to perceive, take care of, control and use the body in a functional manner affects the quality and expression of the movements. According to the theory behind BBAT, movement quality and body awareness are both important abilities to develop bodily self-consciousness.
In order to distinguish between oneself and others, ability to gather and make conscious sensory impressions through the body is demanded. In order to understand the impressions and the world around us, one need to be able to integrate sensory impressions to each other into an information with deeper meaning, the creation of perceptual coherence. The perceptual coherence is the basis for knowledge of one's own body and movement quality. Body awareness increases with more experience of movement. based on the physiotherapeutic bodyself, the subjective ("I as my body") and objective ("I in my body") identity we use to meet and understand the world. The bodyself comes to expression through the degree of movement quality and can as such be observed.
When people with autism grow up, their development differs from typically developed peers. They may find it difficult to understand that other people have their own thoughts and feelings, so-called theory of mind and to understand their own feelings and inner states. They may lack central coherence, being able to merge details to the whole. They may also react differently to smells, flavors, sounds or materials carried on the body, having difficulty imitating others, have less flexibility to achieve motion targets, have poorer motor skills and/or sensorimotor function. In autism, the ability for multi-sensory integration is often inadequate. In this way, context and meaning can become less comprehensible and meaningful. This can lead to changes in the bodyself.
As children with autism exhibit worse body awareness and movement quality than children with typical development, it may be likely that body and movement experiences are reduced through upbringing. This can affect physical and mental health, as seen in autism. A study from 1991 examined how young adults with autism describe how movement quality from a body function perspective affects their ability to maintain daily activities and participation. The attention it required of the individual to attempt to master stereotyped movements to be considered "normal", resulted in increased mental energy utilization as they constantly watched their own behavior, also creating anxiety. In a previous study we interviewed eleven young adults with autism about their experiences about body and movement, as well as examined them with one motor and one body awareness instrument. The results showed conflicting feelings about their bodies and movements, but also how movement quality was related to the way the individual had access to functional strategies to handle everyday situations or not. There is little knowledge about the effects of various interventions that focus on body awareness and movement quality in this group.
The objective of this study is to investigate effects of a BBAT intervention for young adults with autism. Research question: Can an intervention with BBAT help young adults with autism to improve their movement qualities in everyday activities and achieve individually expressed need to improve?
Participants The participants will be young adults with autism, living in the region of Skaraborg in Västra Götaland or in the region of Kronoberg. See 10. Eligibility criteria.
All patients with autism, within the criteria, that has been examined with BAS MQ-E may be eligible for participation in this study. Individual needs for improvement are discussed with each individual. If relevant needs are expressed, which may be encountered with BBAT, and the patient is motivated for intervention, he/she will be included in the study following informed consent. The expressed individual need will be defined in a statement, such as "I experience muscle tensions" or "I can calm myself before bedtime". The intervention will start within one month after performing BAS MQ-E and administered individually. A control group is used within the patient group. With a significance level of 0.05, a power of 0.8 and a moderate effect, at least 20 participants are calculated for in the intervention and control groups respectively.
Ethics The study is approved by The Regional ethical review board in Gothenburg (Dnr 651-17).
Instruments Numeric rating scale Individually expressed health problem is estimated on an individualized 11-degree numeric rating scale (NRS). See 9. Outcome measures.
BAS MQ-E Movement quality will be examined with Body Awareness Scale Movement Quality and Experience (BAS MQ-E). See 9. Outcome measures.
Methods A pragmatic randomized controlled study, pRCT, will be conducted. Participants are jointly managed for Skaraborg and Kronoberg and randomized to intervention group and control group. The distribution is managed by an independent person. Randomization takes place by using a random generator function at http://gallerit.se/slumptal/, with numbers 1 and 2. All 1 means that the participant is randomized to the intervention group, all 2 to the control group.
Intervention group: The layout is individualized based on the results of BAS MQ-E, all three parts. The individually expressed health problem is estimated on the NRS scale. After assessment, 12 occasions are given with BBAT approximately once a week (3-4 months).
Control group: Treatment as usual for 3-4 months. Individualized NRS estimation and assessment with BAS MQ-E are performed according to flowchart. The participant will then have access to BBAT if they wish.
Data collection BAS MQ-E (1) used in the study has been collected either from a previous validation study or from everyday clinic. BAS MQ-E (2), parts Movement test and Questionnaire, will be performed maximum 1 month after the end of the intervention by an independent examiner. Own rating of the individualized health problem using the VAS will be performed prior to the intervention (1), after 7 occasions of intervention (2) and maximum 2 months after last occasion of intervention at 12 weeks, approximately 20 weeks total (3).
Data analysis The primary outcome measure are the results from the NRS ratings. Further, the scores from BAS MQ-E, parts Movement test and Questionnaire, as secondary outcome measure. ANOVA will be used for statistical analysis of differences for repeated measures prior to, during and after the intervention. The intervention- and control groups will be analyzed to each other for any statistical significant difference using Mann Whitney U test (significance level p<0,05).
Clinical significance of the study Body and movements are often described as problems in persons with autism. But it omits that there are also resources in the body to find strategies for everyday life. By strengthening body functions and enhancing movement quality and body awareness through a body therapy intervention, the person with autism can better understand themselves. Strengthened body functions then provide the basis for the individual's opportunities for development and increased participation in society. Expected results thus follow the UN Convention on the Rights of Persons with Disabilities, i.e. to eliminate obstacles for people with disabilities to enjoy their human rights and participation, in full and equal to others.
- Conditions
- Autism
- Being tested
- Body awareness therapy
- Keywords
- Autism, Movement, Body-mind therapy, Physiotherapy
- Medical subject headings
- Autistic Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Body awareness therapyBehavioural
Also called Basic body awareness therapy
The physiotherapist uses body awareness techniques, i.e. guiding the participant in movement qualities such as stability, breathing, flow and grounding. Conscious awareness focused on bodily experiences is a key component to be able to reflect on what your body signals.
As a baseline a standardized observation of the movement quality of the individual is performed. The physiotherapist needs special education in the body awareness technique used, to rightly perform and analyse the observation and administer the intervention.
The aim of the body awareness therapy is to raise physical and mental awareness by strengthening the interplay between sensory impressions and motor ability and to gain knowledge of own movement patterns that are not functional and to form alternatives to these.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Active comparator | Twelve occasions of Basic body awareness therapy, administered once a week, alongside treatment as usual (such as structured everyday support, medicine, contact with social worker). Receives: Behavioral: Body awareness therapy |
| Control group | No intervention | No extra intervention except treatment as usual. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of experienced health problem from Numeric rating scale
The scale is a Numeric rating scale, 15 cm long with 11 vertical lines, marked from 0 to 10. One individual health problem will be identified by the participant. The health problem needs to be judged by the physiotherapist as relevant to meet with body awareness intervention. If so, the sentence will be typed above the scale before rating. A health problem could for instance be "I experience muscle tensions". 0=no problems experienced and 10=extreme problems, i.e. 0 is the best value. In order to follow any process of change, an intermediate measure will be performed.
Measured: 1.) Maximum 2 months prior to intervention, 2.) after 7 occasions of therapy and 3.) maximum 2 months after last occasion of intervention at 12 weeks, approximately 20 weeks total
Secondary outcomes (1)
Change of results of Body Awareness Scale Movement Quality and Experiences, BAS MQ-E
1.) Movement test: 23-item physiotherapeutic observation of movement quality, rated ordinally in a 5-graded scale, 0=vitality to 4=pathology/not executing. 2.) Questionnaire: Own rating of 7 items about how one´s body works in everyday life, 4-graded ordinally scale, 0=no problems to 3=don´t work 3.) Experienced-based interview: The participant is asked to describe experiences from his/her body during four standardized movements from the Movement test (part one). Their descriptions are written down verbatim. Both qualitative and quantitative data are obtained with this instrument.
Measured: 1.) Maximum 2 months prior to intervention and 2.) maximum 2 months after last occasion of intervention at 12 weeks, approximately 20 weeks total
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2018
- Study start1 May 2018
- Primary completion15 Jun 2022
- Study completion15 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (17)Papers the sponsor has linked to this study.
- Other trials for AutismStudies 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
- None (open label)
- Enrolment
- 57 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lund University
- Sponsor type
- University, hospital or other
- Collaborators
- Vastra Gotaland Region
- Responsible party
- Sponsor
- Investigators
- Catharina Sjödahl Hammarlund, As.professo, Study chair, Lund University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03723876
- Sponsor's protocol ID
- Ingrid Bertilsson
- Status last verified
- Jun 2022
- First submitted
- 21 Jun 2018
- Last updated
- 1 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Bertilsson I, Gyllensten AL, Opheim A, Gard G, Sjodahl Hammarlund C. Understanding one's body and movements from the perspective of young adults with autism: A mixed-methods study. Res Dev Disabil. 2018 Jul;78:44-54. doi: 10.1016/j.ridd.2018.05.002. Epub 2018 May 15.
PubMed 29772450Bhat AN, Landa RJ, Galloway JC. Current perspectives on motor functioning in infants, children, and adults with autism spectrum disorders. Phys Ther. 2011 Jul;91(7):1116-29. doi: 10.2522/ptj.20100294. Epub 2011 May 5.
PubMed 21546566Cesaroni L, Garber M. Exploring the experience of autism through firsthand accounts. J Autism Dev Disord. 1991 Sep;21(3):303-13. doi: 10.1007/BF02207327.
PubMed 1938776Einspieler C, Sigafoos J, Bolte S, Bratl-Pokorny KD, Landa R, Marschik PB. Highlighting the first 5 months of life: General movements in infants later diagnosed with autism spectrum disorder or Rett Syndrome. Res Autism Spectr Disord. 2014 Mar;8(3):286-291. doi: 10.1016/j.rasd.2013.12.013. Epub 2014 Jan 9.
PubMed 29770159Frith U, Happe F. Autism: beyond "theory of mind". Cognition. 1994 Apr-Jun;50(1-3):115-32. doi: 10.1016/0010-0277(94)90024-8.
PubMed 8039356Gyllensten, A. L. (2012). Basal kroppskännedom. i G. Biguet, R. Keskinen-Rosenqvist, & A. Levy Berg, Att förstå kroppens signaler - sjukgymnastiska perspektiv (ss. 189-206). Lund: Studentlitteratur.
Gyllensten, A. L., Hansson, L., & Ekdahl, C. (2003). Patient experiences of basic body awareness therapy and the relationship with the physiotherapist. Journal of Bodywork and Movement Therapies, 7, 173-183.
Hedlund, L. (2014). Basal kroppskännedom och psykomotorisk funktion hos personer med allvarlig psykisk sjukdom. Doctoral thesis, Lund: Department of Health Science, Division of Physiotherapy.
Kopp S, Beckung E, Gillberg C. Developmental coordination disorder and other motor control problems in girls with autism spectrum disorder and/or attention-deficit/hyperactivity disorder. Res Dev Disabil. 2010 Mar-Apr;31(2):350-61. doi: 10.1016/j.ridd.2009.09.017. Epub 2009 Nov 11.
PubMed 19910158Lai MC, Lombardo MV, Baron-Cohen S. Autism. Lancet. 2014 Mar 8;383(9920):896-910. doi: 10.1016/S0140-6736(13)61539-1. Epub 2013 Sep 26.
PubMed 24074734Norman, G., & Streiner, D. (2014). Biostatistics. The bare essentials. Ontario: PMPH-USA Limited.
Regeringskansliet. (2008). FN:s konvention om rättigheter för personer med funktionsnedsättning. Hämtat från http://www.regeringen.se/contentassets/0b52fa83450445aebbf88827ec3eecb8/fns-konvention-om-rattigheter-for-personer-med-funktionsnedsattning-ds-200823
Rizzolatti G, Fabbri-Destro M. Mirror neurons: from discovery to autism. Exp Brain Res. 2010 Jan;200(3-4):223-37. doi: 10.1007/s00221-009-2002-3. Epub 2009 Sep 18. No abstract available.
PubMed 19760408Simons J, Leitschuh C, Raymaekers A, Vandenbussche I. Body awareness in preschool children with psychiatric disorder. Res Dev Disabil. 2011 Sep-Oct;32(5):1623-30. doi: 10.1016/j.ridd.2011.02.011. Epub 2011 Mar 24.
PubMed 21435833Skjaerven, L., Gard, G., & Kristoffersen, K. (2003). Basic elements and dimensions to the phenomenon of quality of movement - a case study. Journal of bodywork and movement therapies.
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Basic Body Awareness Therapy for Persons With Autism. A Pragmatic Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT03723876
- Acronym / sponsor ID
- Ingrid Bertilsson
- Conditions
- Autism
- Keywords
- Autism, Movement, Body-mind therapy, Physiotherapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 57 participants (actual)
- Lead sponsor
- Lund UniversityUniversity, hospital or other
- Collaborators
- Vastra Gotaland Region
- Study start
- 1 May 2018 (actual)
- Primary completion
- 15 Jun 2022 (actual)
- Study completion
- 15 Jun 2022 (actual)
- First posted
- 30 Oct 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Autism is a diagnosis with certain criteria, especially social and communicative disabilities. Several body functions may be affected to create these disabilities, such as lack of ability to understand that other people think or feel differently than the person with autism, difficulty to experience bodily signals or deviant function of sensory modalities.
Several theories describe that our physical, physiological, psychological and existential being can not be separated from each other. The combination of described difficulties in autism makes the perception of the surrounding world or the people within it difficult to understand or interpret, i.e., lack of a sense of coherence. The inner experience of the person as well as the expression of his/her movement qualities will be the effects.
There are physiotherapeutic intervention techniques of body awareness, with the purpose to increase the connection to the body and to work with more functional movements. Instead of working with improving the well-being by cognitive top-down techniques, body awareness techniques work bottom-up.
The hypothesis is that an intervention with body awareness therapy will increase the possibility for persons with autism to improve movement quality, and increase contact with bodily signals. It will give a better chance to understand and interpret the world and people in different context, conquering a sense of coherence.
The study include at least 40 participants with autism randomized to two groups: 1.) intervention once a week for 12 weeks and 2. ) a control group (who will be invited to the therapy after ending study participation). They will be recruited from patient records in habilitation care. The criteria are: having autism, being 15-30 years, not having an intellectual impairment and not having a severe depression. The participants are to have been assessed with the standardized "Basic Body Awareness Scale Movement Quality and Experience", BAS MQ-E, and been found to being relevant participants for body awareness intervention in regard to the expressed individual health problem.
Two assessments will be used. The primary one addresses each participants´s individual health problem, using a visual 11-graded scale (NRS), grading the present experience of the health problem. The secondary one is BAS MQ-E. The assessments will be administered as follows: i) prior to; NRS + BAS MQ-E, ii) after 7 occasions; NRS and iii) maximum 2 months after intervention; NRS + BAS MQ-E.
Detailed description
Introduction Movement quality is a concept that describes how movements are performed in space, time and amount of energy. When the quality is good, the movement is perceived as unrestricted and gives a sense of freedom, physically and mentally. Movement quality and body awareness are dependent on each other. Body awareness is the ability to be consciously present and interpret signals from your own body. A physiotherapeutic treatment method that describes how movement quality and body awareness interact on a deeper level is Basic Body Awareness Therapy (BBAT).
The purpose of BBAT is to raise physical and mental awareness by strengthening the interplay between sensory impressions and motor ability, gaining knowledge of movement patterns and habits that are not functional. Man's ability to perceive, take care of, control and use the body in a functional manner affects the quality and expression of the movements. According to the theory behind BBAT, movement quality and body awareness are both important abilities to develop bodily self-consciousness.
In order to distinguish between oneself and others, ability to gather and make conscious sensory impressions through the body is demanded. In order to understand the impressions and the world around us, one need to be able to integrate sensory impressions to each other into an information with deeper meaning, the creation of perceptual coherence. The perceptual coherence is the basis for knowledge of one's own body and movement quality. Body awareness increases with more experience of movement. based on the physiotherapeutic bodyself, the subjective ("I as my body") and objective ("I in my body") identity we use to meet and understand the world. The bodyself comes to expression through the degree of movement quality and can as such be observed.
When people with autism grow up, their development differs from typically developed peers. They may find it difficult to understand that other people have their own thoughts and feelings, so-called theory of mind and to understand their own feelings and inner states. They may lack central coherence, being able to merge details to the whole. They may also react differently to smells, flavors, sounds or materials carried on the body, having difficulty imitating others, have less flexibility to achieve motion targets, have poorer motor skills and/or sensorimotor function. In autism, the ability for multi-sensory integration is often inadequate. In this way, context and meaning can become less comprehensible and meaningful. This can lead to changes in the bodyself.
As children with autism exhibit worse body awareness and movement quality than children with typical development, it may be likely that body and movement experiences are reduced through upbringing. This can affect physical and mental health, as seen in autism. A study from 1991 examined how young adults with autism describe how movement quality from a body function perspective affects their ability to maintain daily activities and participation. The attention it required of the individual to attempt to master stereotyped movements to be considered "normal", resulted in increased mental energy utilization as they constantly watched their own behavior, also creating anxiety. In a previous study we interviewed eleven young adults with autism about their experiences about body and movement, as well as examined them with one motor and one body awareness instrument. The results showed conflicting feelings about their bodies and movements, but also how movement quality was related to the way the individual had access to functional strategies to handle everyday situations or not. There is little knowledge about the effects of various interventions that focus on body awareness and movement quality in this group.
The objective of this study is to investigate effects of a BBAT intervention for young adults with autism. Research question: Can an intervention with BBAT help young adults with autism to improve their movement qualities in everyday activities and achieve individually expressed need to improve?
Participants The participants will be young adults with autism, living in the region of Skaraborg in Västra Götaland or in the region of Kronoberg. See 10. Eligibility criteria.
All patients with autism, within the criteria, that has been examined with BAS MQ-E may be eligible for participation in this study. Individual needs for improvement are discussed with each individual. If relevant needs are expressed, which may be encountered with BBAT, and the patient is motivated for intervention, he/she will be included in the study following informed consent. The expressed individual need will be defined in a statement, such as "I experience muscle tensions" or "I can calm myself before bedtime". The intervention will start within one month after performing BAS MQ-E and administered individually. A control group is used within the patient group. With a significance level of 0.05, a power of 0.8 and a moderate effect, at least 20 participants are calculated for in the intervention and control groups respectively.
Ethics The study is approved by The Regional ethical review board in Gothenburg (Dnr 651-17).
Instruments Numeric rating scale Individually expressed health problem is estimated on an individualized 11-degree numeric rating scale (NRS). See 9. Outcome measures.
BAS MQ-E Movement quality will be examined with Body Awareness Scale Movement Quality and Experience (BAS MQ-E). See 9. Outcome measures.
Methods A pragmatic randomized controlled study, pRCT, will be conducted. Participants are jointly managed for Skaraborg and Kronoberg and randomized to intervention group and control group. The distribution is managed by an independent person. Randomization takes place by using a random generator function at http://gallerit.se/slumptal/, with numbers 1 and 2. All 1 means that the participant is randomized to the intervention group, all 2 to the control group.
Intervention group: The layout is individualized based on the results of BAS MQ-E, all three parts. The individually expressed health problem is estimated on the NRS scale. After assessment, 12 occasions are given with BBAT approximately once a week (3-4 months).
Control group: Treatment as usual for 3-4 months. Individualized NRS estimation and assessment with BAS MQ-E are performed according to flowchart. The participant will then have access to BBAT if they wish.
Data collection BAS MQ-E (1) used in the study has been collected either from a previous validation study or from everyday clinic. BAS MQ-E (2), parts Movement test and Questionnaire, will be performed maximum 1 month after the end of the intervention by an independent examiner. Own rating of the individualized health problem using the VAS will be performed prior to the intervention (1), after 7 occasions of intervention (2) and maximum 2 months after last occasion of intervention at 12 weeks, approximately 20 weeks total (3).
Data analysis The primary outcome measure are the results from the NRS ratings. Further, the scores from BAS MQ-E, parts Movement test and Questionnaire, as secondary outcome measure. ANOVA will be used for statistical analysis of differences for repeated measures prior to, during and after the intervention. The intervention- and control groups will be analyzed to each other for any statistical significant difference using Mann Whitney U test (significance level p<0,05).
Clinical significance of the study Body and movements are often described as problems in persons with autism. But it omits that there are also resources in the body to find strategies for everyday life. By strengthening body functions and enhancing movement quality and body awareness through a body therapy intervention, the person with autism can better understand themselves. Strengthened body functions then provide the basis for the individual's opportunities for development and increased participation in society. Expected results thus follow the UN Convention on the Rights of Persons with Disabilities, i.e. to eliminate obstacles for people with disabilities to enjoy their human rights and participation, in full and equal to others.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Active comparator | Behavioral: Body awareness therapyTwelve occasions of Basic body awareness therapy, administered once a week, alongside treatment as usual (such as structured everyday support, medicine, contact with social worker). |
| Control group | No intervention | –No extra intervention except treatment as usual. |
Who may qualify
- Ages
- 15 to 30 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- diagnosed with an autism diagnosis (F84* in ICD-10)
- 15-30 years
- accepted for care at habilitation unit
Key exclusion criteria (3 listed)
- diagnosed with intellectual disability (F70*-F73*, F78*-F79* in ICD-10)
- medium or severe depression
- major problems with country´s native language
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 |
|---|---|---|
| Body awareness therapyAlso: Basic body awareness therapyThe physiotherapist uses body awareness techniques, i.e. guiding the participant in movement qualities such as stability, breathing, flow and grounding. Conscious awareness focused on bodily experiences is a key component to be able to reflect on what your body signals. As a baseline a standardized observation of the movement quality of the individual is performed. The physiotherapist needs special education in the body awareness technique used, to rightly perform and analyse the observation and administer the intervention. The aim of the body awareness therapy is to raise physical and mental awareness by strengthening the interplay between sensory impressions and motor ability and to gain knowledge of own movement patterns that are not functional and to form alternatives to these. | Behavioural | Intervention group |
Primary outcome
Change of experienced health problem from Numeric rating scale
Time frame: 1.) Maximum 2 months prior to intervention, 2.) after 7 occasions of therapy and 3.) maximum 2 months after last occasion of intervention at 12 weeks, approximately 20 weeks total
The scale is a Numeric rating scale, 15 cm long with 11 vertical lines, marked from 0 to 10. One individual health problem will be identified by the participant. The health problem needs to be judged by the physiotherapist as relevant to meet with body awareness intervention. If so, the sentence will be typed above the scale before rating. A health problem could for instance be "I experience muscle tensions". 0=no problems experienced and 10=extreme problems, i.e. 0 is the best value. In order to follow any process of change, an intermediate measure will be performed.
1 secondary outcome
Change of results of Body Awareness Scale Movement Quality and Experiences, BAS MQ-E
Time frame: 1.) Maximum 2 months prior to intervention and 2.) maximum 2 months after last occasion of intervention at 12 weeks, approximately 20 weeks total
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2022.
- Background: PubMed 29772450Bertilsson I, Gyllensten AL, Opheim A, Gard G, Sjodahl Hammarlund C. Understanding one's body and movements from the perspective of young adults with autism: A mixed-methods study. Res Dev Disabil. 2018 Jul;78:44-54. doi: 10.1016/j.ridd.2018.05.002. Epub 2018 May 15.
- Background: PubMed 21546566Bhat AN, Landa RJ, Galloway JC. Current perspectives on motor functioning in infants, children, and adults with autism spectrum disorders. Phys Ther. 2011 Jul;91(7):1116-29. doi: 10.2522/ptj.20100294. Epub 2011 May 5.
- Background: PubMed 1938776Cesaroni L, Garber M. Exploring the experience of autism through firsthand accounts. J Autism Dev Disord. 1991 Sep;21(3):303-13. doi: 10.1007/BF02207327.
- Background: PubMed 29770159Einspieler C, Sigafoos J, Bolte S, Bratl-Pokorny KD, Landa R, Marschik PB. Highlighting the first 5 months of life: General movements in infants later diagnosed with autism spectrum disorder or Rett Syndrome. Res Autism Spectr Disord. 2014 Mar;8(3):286-291. doi: 10.1016/j.rasd.2013.12.013. Epub 2014 Jan 9.
- Background: PubMed 8039356Frith U, Happe F. Autism: beyond "theory of mind". Cognition. 1994 Apr-Jun;50(1-3):115-32. doi: 10.1016/0010-0277(94)90024-8.
- BackgroundGyllensten, A. L. (2012). Basal kroppskännedom. i G. Biguet, R. Keskinen-Rosenqvist, & A. Levy Berg, Att förstå kroppens signaler - sjukgymnastiska perspektiv (ss. 189-206). Lund: Studentlitteratur.
- BackgroundGyllensten, A. L., Hansson, L., & Ekdahl, C. (2003). Patient experiences of basic body awareness therapy and the relationship with the physiotherapist. Journal of Bodywork and Movement Therapies, 7, 173-183.
- BackgroundHedlund, L. (2014). Basal kroppskännedom och psykomotorisk funktion hos personer med allvarlig psykisk sjukdom. Doctoral thesis, Lund: Department of Health Science, Division of Physiotherapy.
- Background: PubMed 19910158Kopp S, Beckung E, Gillberg C. Developmental coordination disorder and other motor control problems in girls with autism spectrum disorder and/or attention-deficit/hyperactivity disorder. Res Dev Disabil. 2010 Mar-Apr;31(2):350-61. doi: 10.1016/j.ridd.2009.09.017. Epub 2009 Nov 11.
- Background: PubMed 24074734Lai MC, Lombardo MV, Baron-Cohen S. Autism. Lancet. 2014 Mar 8;383(9920):896-910. doi: 10.1016/S0140-6736(13)61539-1. Epub 2013 Sep 26.
- BackgroundNorman, G., & Streiner, D. (2014). Biostatistics. The bare essentials. Ontario: PMPH-USA Limited.
- BackgroundRegeringskansliet. (2008). FN:s konvention om rättigheter för personer med funktionsnedsättning. Hämtat från http://www.regeringen.se/contentassets/0b52fa83450445aebbf88827ec3eecb8/fns-konvention-om-rattigheter-for-personer-med-funktionsnedsattning-ds-200823
- Individual participant dataSharing planned: No
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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.
Catharina Sjödahl Hammarlund, As.professo study chair
Lund University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Body awareness therapy in people with Autism, run by Lund University at 2 sites 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 3 inclusion and 3 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 1 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Change of experienced health problem from Numeric rating scale (time frame: 1.) Maximum 2 months prior to intervention, 2.) after 7 occasions of therapy and 3.) maximum 2 months after last occasion of intervention at 12 weeks, approximately 20 weeks total). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03723876, which also lists 17 linked publications.
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 1 Jul 2022.