Autism Clinical Trial
Official title:
Basic Body Awareness Therapy for Persons With Autism. A Pragmatic Randomized Controlled Study
Verified date | June 2022 |
Source | Lund University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 57 |
Est. completion date | June 15, 2022 |
Est. primary completion date | June 15, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 15 Years to 30 Years |
Eligibility | Inclusion Criteria: - diagnosed with an autism diagnosis (F84* in ICD-10) - 15-30 years - accepted for care at habilitation unit Exclusion Criteria: - diagnosed with intellectual disability (F70*-F73*, F78*-F79* in ICD-10) - medium or severe depression - major problems with country´s native language |
Country | Name | City | State |
---|---|---|---|
Sweden | Habiliteringen Vastra Gotalandsregionen | Skovde | Vastra Gotaland |
Sweden | Vuxenhabiliteringen | Vaxjo | Kronoberg |
Lead Sponsor | Collaborator |
---|---|
Lund University | Vastra Gotaland Region |
Sweden,
Bertilsson I, Gyllensten AL, Opheim A, Gard G, Sjödahl 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. — View Citation
Bhat 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. — View Citation
Cesaroni L, Garber M. Exploring the experience of autism through firsthand accounts. J Autism Dev Disord. 1991 Sep;21(3):303-13. — View Citation
Einspieler C, Sigafoos J, Bölte 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. — View Citation
Frith U, Happé F. Autism: beyond "theory of mind". Cognition. 1994 Apr-Jun;50(1-3):115-32. Review. — View Citation
Gyllensten, 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. — View Citation
Lai 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. Review. — View Citation
Norman, 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. Review. — View Citation
Simons 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. — View Citation
Skjaerven, 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.
Whyatt C, Craig C. Sensory-motor problems in Autism. Front Integr Neurosci. 2013 Jul 18;7:51. doi: 10.3389/fnint.2013.00051. eCollection 2013. — View Citation
* Note: There are 16 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. | 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 | 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. | 1.) Maximum 2 months prior to intervention and 2.) maximum 2 months after last occasion of intervention at 12 weeks, approximately 20 weeks total |
Status | Clinical Trial | Phase | |
---|---|---|---|
Active, not recruiting |
NCT05302167 -
Molehill Mountain Feasibility Study.
|
N/A | |
Completed |
NCT04167839 -
Effects of Sensory Diets on Children's Sensory Processing Skills, Psychosocial Skills, and Classroom Engagement
|
N/A | |
Terminated |
NCT04049981 -
Investigation of Mechanisms of Action in Superpower Glass
|
Phase 1/Phase 2 | |
Active, not recruiting |
NCT06080087 -
Implementation Toolkit to Enhance EBP Among Marginalized Families
|
N/A | |
Recruiting |
NCT04107064 -
Achieving Steady Work Among Adults With Autism Through Specialized Employment Program
|
N/A | |
Completed |
NCT03206996 -
Exposure Therapy for Auditory Sensitivity in Autism
|
N/A | |
Completed |
NCT01914393 -
Pediatric Open-Label Extension Study
|
Phase 3 | |
Completed |
NCT05588570 -
Coaching Children With Anxiety and Autism Through Telehealth
|
N/A | |
Enrolling by invitation |
NCT06058104 -
Evaluating Efficacy of a Digital Game Therapeutic for Children With Autism
|
N/A | |
Withdrawn |
NCT02414451 -
Trial of Propranolol in Adults and Adolescents With ASD and Predictors of Response
|
N/A | |
Completed |
NCT02911194 -
a2 Milk for Autism and Attention-deficit Hyperactivity Disorder (ADHD)
|
N/A | |
Completed |
NCT02847182 -
Cord Blood Infusion for Children With Autism Spectrum Disorder
|
Phase 2 | |
Completed |
NCT03002363 -
The Effects of Video Modeling of Audiological Testing on Pediatric Patient Compliance
|
Phase 1 | |
Completed |
NCT02508922 -
Trial of Vitamin D3 Supplementation in Paediatric Autism
|
N/A | |
Completed |
NCT02536365 -
Sensory Integration Therapy in Autism: Mechanisms and Effectiveness
|
N/A | |
Completed |
NCT02720900 -
Prebiotic Intervention for Autism Spectrum Disorders
|
N/A | |
Completed |
NCT02708290 -
Mental Imagery Therapy for Autism (MITA) - an Early Intervention Computerized Language Training Program for Children With ASD
|
||
Recruiting |
NCT02255565 -
Dose Response Effects of Quillivant XR in Children With ADHD and Autism: A Pilot Study
|
Phase 4 | |
Recruiting |
NCT01836562 -
A Clinical Trial to Study the Safety and Efficacy of Bone Marrow Derived Autologous Cells for the Treatment of Autism
|
Phase 1/Phase 2 | |
Completed |
NCT02154828 -
Clinical Evaluation of Integrative Practices Units Infant and Child Care for Unit Children With Typical or Atypical Autism (AUTISM)
|