NCT04523805

Brief Summary

The project is aligned with one of the overall: To promote social inclusion and equal opportunities, encouraging participation in sport and physical activity. With this goal in mind, the following specific objectives for this project were established:

  1. 1.To develop an adapted judo programme for children with ASD.
  2. 2.To demonstrate the impact of the participation in adapted judo on the quality of life of people with ASD.
  3. 3.To validate instruments for use among the population with ASD.
  4. 4.To establish a set of coherent pedagogical principles that can be applied throughout the EU to ensure the effectiveness of adapted judo programmes for children with ASD.
  5. 5.To establish a coherent set of pedagogical principles to promote good habits in the participation in judo by children with ASD.
  6. 6.To consolidate and disseminate a systematic approach to adapted judo participation and competition for people with ASD around the EU.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2019

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2019

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2020

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

August 11, 2020

Completed
13 days until next milestone

First Posted

Study publicly available on registry

August 24, 2020

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2021

Completed
Last Updated

August 24, 2020

Status Verified

August 1, 2020

Enrollment Period

1 year

First QC Date

August 11, 2020

Last Update Submit

August 20, 2020

Conditions

Keywords

Exercise interventionAdapted judo interventionGARS-3TGMD-3

Outcome Measures

Primary Outcomes (2)

  • Change from Pre-intervention in psycho-social and behavioural scores

    Gilliam Autism Rating Scale-Third Edition (GARS-3) scale (Gilliam, 2014). It includes 56 items describing characteristic behaviours of individuals with autism. The items are divided into six subscales: repetitive behaviours (RB), social interaction (SI), social communication (SC), emotional responses (ER), cognitive style (CS), and maladaptive speech (MS). Each item is scored on a four-point Likert-type scale (0=never observed; to 3=frequently observed), score indicates severity of autism-related behaviours and a lower value represents an improvement. The instrument can be administered by parents or caregivers in 5-10 minutes. It is based on the frequency of occurrence of each item under ordinary circumstances in a six-hour period. The raw score for each subscale was used. ), it should be noted that a low score indicates a decrease in the severity of the characteristics of children with ASD. Change= Pre-intervention (T2- control period) week 8- Post-intervention (T3-judo) week 16

    Up to 16 weeks

  • Change from Pre-intervention in motor skills scores

    * Battery ALPHA-FITNESS. It obtains the following variables: weight, height, body composition (abdominal perimeter, triceps sheet, subscapular fold), hand strength, leg strength, agility and aerobic endurance. Scale will be reported (min 1-50) higher scores mean a better outcome. * Test of Gross Motor Development (TGMD-3). Evaluates two components: a) Locomotor: Measures gross motor skills that require movements made with a fluid coordination (running, galloping, jumping with one foot, stride, jump with two feet slide). b) Object control: This subtest measures the gross motor skills that require efficiency when throwing, hitting and receiving (hitting a static ball, static jump, reception, shooting, throwing over the head and throwing below the head). Scale will be reported (min 3-36) higher scores mean a better outcome. Change= Pre-intervention (T2- control period) week 8- Post-intervention (T3-judo) week 16

    Up to 16 weeks

Secondary Outcomes (2)

  • Change from Baseline in psycho-social and behavioural scores

    Up to 8 weeks

  • Change from Baseline in motor skills scores

    Up to 8 weeks

Other Outcomes (3)

  • Change from post-intervention in psycho-social and behavioural scores

    Up to 24 weeks

  • Change from post-intervention in motor skills scores

    Up to 24 weeks

  • Level of Physical Activity Enjoyment

    Up to 16 weeks

Study Arms (1)

AUTJUDO-O1

EXPERIMENTAL

The judo sessions are performing in a large and well-ventilated space suitable for athletic activities in general and for judo in particular, such that the safety of the participants was maintained. Each participant is outfitted with a judogi (a traditional uniform consisting of a cotton jacket and trousers and a belt). The sessions are 75 minutes in duration and were held once a week. Two judo teachers, with degrees in pedagogy and sports sciences and 7th and 6th degree black belts, respectively, led each session, and at least four volunteer judo instructors are present to lend support. The sessions are divided into warm-up, main exercise and cool-down activities. The instructional methodology apply the principles of gradual progression and the main exercise content of the sessions includes: different types of movements and falling techniques, ground control techniques, judo techniques and games.

Behavioral: Adapted judo programme

Interventions

The judo sessions were 75 minutes in duration and were held once a week. Two judo teachers led each session, and at least four volunteer judo instructors were present to lend support. The sessions were divided into warm-up, main exercise and cool-down activities. The main exercise content of the sessions included: * Different types of movements and falling techniques (from walking in all directions to turning around, from stable movements to unstable movements). * Judo techniques and games (building up body contact with games, teaching simplified movements, essential judo movements) (blinded for review). * Ground control techniques and throws (gradually adding techniques to already known movements, scaffolding basic repetitive movements to assist in understanding to those more relevant for judo ). * Repetition of different forms of foundational directional movements (pulling, pushing, holding, lifting).

AUTJUDO-O1

Eligibility Criteria

Age8 Years - 15 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Clinical diagnosis of ASD.

You may not qualify if:

  • Clinical disability for physical activity

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Jose Morales

Barcelona, 08022, Spain

Location

Related Publications (7)

  • Ruiz JR, Castro-Pinero J, Espana-Romero V, Artero EG, Ortega FB, Cuenca MM, Jimenez-Pavon D, Chillon P, Girela-Rejon MJ, Mora J, Gutierrez A, Suni J, Sjostrom M, Castillo MJ. Field-based fitness assessment in young people: the ALPHA health-related fitness test battery for children and adolescents. Br J Sports Med. 2011 May;45(6):518-24. doi: 10.1136/bjsm.2010.075341. Epub 2010 Oct 19.

    PMID: 20961915BACKGROUND
  • Karren, B. C. (2017). A Test Review: Gilliam, JE (2014). Gilliam Autism Rating Scale-Third Edition (GARS-3).

    BACKGROUND
  • Randall M, Egberts KJ, Samtani A, Scholten RJ, Hooft L, Livingstone N, Sterling-Levis K, Woolfenden S, Williams K. Diagnostic tests for autism spectrum disorder (ASD) in preschool children. Cochrane Database Syst Rev. 2018 Jul 24;7(7):CD009044. doi: 10.1002/14651858.CD009044.pub2.

    PMID: 30075057BACKGROUND
  • Allen KA, Bredero B, Van Damme T, Ulrich DA, Simons J. Test of Gross Motor Development-3 (TGMD-3) with the Use of Visual Supports for Children with Autism Spectrum Disorder: Validity and Reliability. J Autism Dev Disord. 2017 Mar;47(3):813-833. doi: 10.1007/s10803-016-3005-0.

    PMID: 28091840BACKGROUND
  • Latorre Roman PA, Garcia Pinillos F, Navarro Martinez AV, Izquierdo Rus T. Validity and reliability of Physical Activity Enjoyment Scale questionnaire (PACES) in children with asthma. J Asthma. 2014 Aug;51(6):633-8. doi: 10.3109/02770903.2014.898773. Epub 2014 Mar 24.

    PMID: 24580370BACKGROUND
  • Teques P, Calmeiro L, Silva C, Borrego C. Validation and adaptation of the Physical Activity Enjoyment Scale (PACES) in fitness group exercisers. J Sport Health Sci. 2020 Jul;9(4):352-357. doi: 10.1016/j.jshs.2017.09.010. Epub 2017 Sep 29.

    PMID: 32768128BACKGROUND
  • Pierantozzi E, Morales J, Fukuda DH, Garcia V, Gomez AM, Guerra-Balic M, Carballeira E. Effects of a Long-Term Adapted Judo Program on the Health-Related Physical Fitness of Children with ASD. Int J Environ Res Public Health. 2022 Dec 13;19(24):16731. doi: 10.3390/ijerph192416731.

MeSH Terms

Conditions

Autism Spectrum Disorder

Condition Hierarchy (Ancestors)

Child Development Disorders, PervasiveNeurodevelopmental DisordersMental Disorders

Study Officials

  • Myriam Guerra-Balic, Dr

    URamonLull

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Model Details: Baseline data are collected at T1-Baseline, at the start of the programme and eight weeks later, scores are recorded for T2-Control, which represents a control period. During the control period, part of which includes the winter break from classes, the students not participate in any extracurricular physical activities, as their organised physical exercise is limited to their regular physical education classes at school. Between this second measurement and T3-Judo. T4-Follow up The judo sessions are performing in a large and well-ventilated space suitable for athletic activities in general and for judo in particular, such that the safety of the participants was maintained. Each participant is outfitted with a judogi (a traditional uniform consisting of a cotton jacket and trousers and a belt). The choice was made to include the control period at the start of the process because we did not have a control group willing to submit to all the measurements over the course of the project.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

August 11, 2020

First Posted

August 24, 2020

Study Start

July 1, 2019

Primary Completion

July 1, 2020

Study Completion

July 1, 2021

Last Updated

August 24, 2020

Record last verified: 2020-08

Data Sharing

IPD Sharing
Will not share

Locations