Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Basic Body Awareness Therapy for Persons With Autism

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03723876
Recruitment Status : Active, not recruiting
First Posted : October 30, 2018
Last Update Posted : April 7, 2022
Sponsor:
Collaborator:
Vastra Gotaland Region
Information provided by (Responsible Party):
Lund University

Brief 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 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.


Condition or disease Intervention/treatment Phase
Autism Behavioral: Body awareness therapy Not Applicable

Show Show detailed description

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Basic Body Awareness Therapy for Persons With Autism. A Pragmatic Randomized Controlled Study
Actual Study Start Date : May 1, 2018
Estimated Primary Completion Date : May 2022
Estimated Study Completion Date : May 2022

Arm Intervention/treatment
Active Comparator: Intervention group
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).
Behavioral: 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.

Other Name: Basic body awareness therapy

No Intervention: Control group
No extra intervention except treatment as usual.



Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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 ]
    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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   15 Years to 30 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03723876


Locations
Layout table for location information
Sweden
Vuxenhabiliteringen
Vaxjo, Kronoberg, Sweden
Habiliteringen Vastra Gotalandsregionen
Skovde, Vastra Gotaland, Sweden, 54150
Sponsors and Collaborators
Lund University
Vastra Gotaland Region
Investigators
Layout table for investigator information
Study Chair: Catharina Sjödahl Hammarlund, As.professo Lund University
Publications:
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.
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
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.

Layout table for additonal information
Responsible Party: Lund University
ClinicalTrials.gov Identifier: NCT03723876    
Other Study ID Numbers: Ingrid Bertilsson
First Posted: October 30, 2018    Key Record Dates
Last Update Posted: April 7, 2022
Last Verified: April 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Lund University:
Autism
Movement
Body-mind therapy
Physiotherapy
Additional relevant MeSH terms:
Layout table for MeSH terms
Autistic Disorder
Autism Spectrum Disorder
Child Development Disorders, Pervasive
Neurodevelopmental Disorders
Mental Disorders