Motor Intervention Whit the Intorus Tool on Children With Down Syndrome
Condition: Down Syndrome
MeSH terms: Down Syndrome; Syndrome
Study type: Interventional

Summary: 
      The goal of this clinical trial is to test in people with down syndrome how does the INTORUS
      tool influence their psychomotor development. The main question it aims to answer is:

      - Does the INTORUS tool improve psychomotor development in people with Down Syndrome? The
      intervention program will be carried out during the Functional Habilitation sessions and will
      be carried out by the center's professionals. These sessions must be carried out in a quiet
      environment, without distractions so that the user can concentrate on carrying out the
      activities. It is important that the user attends the sessions in comfortable, sleeveless
      clothing, to allow the tool to slide smoothly through their upper limbs.

      Each session will consist of several exercises with their corresponding rest breaks described
      in the Intervention Protocol. Each session attendance will be recorded following an
      attendance record model created for the occasion.

      Participants will be divided into two groups randomly. The control group will receive an
      intervention treatment at the psychomotor level in the traditional way, following the
      protocols established in the center, and the intervention group will receive an intervention
      treatment at the psychomotor level with the INTORUS device.

      Randomization will be carried out using the Oxford Minimization and Randomization software.
    

Detailed description: 
      POPULATION The population of interest are users of the Functional Habilitation Service of the
      Centers of the Down Syndrome Association of Cáceres and Plasencia

      INCLUSION CRITERIA

        -  Users with Down Syndrome

        -  Ages between 4 and 18 years.

        -  Informed consent signed by parents/guardians.

      EXCLUSION CRITERIA

        -  Users without Down Syndrome.

        -  Under 4 years and over 18 years.

      A total of approximately 100 users will participate in the study. Participants will be
      divided into two groups randomly. The control group will receive an intervention treatment at
      the psychomotor level in the traditional way, following the protocols established in the
      center, and the intervention group will receive an intervention treatment at the psychomotor
      level with the INTORUS device.

      Randomization will be carried out using the OxMaR (Oxford Minimization and Randomization)
      software.

      PROJECT REGISTRATION The project has been approved by the Bioethics and Biosafety Commission
      of the University of Extremadura as of 12/19/2022.

      INTERVENTION PROGRAM

      The intervention program will be carried out during the Functional Habilitation sessions and
      will be carried out by the center's professionals. These sessions must be carried out in a
      quiet environment, without distractions so that the user can concentrate on carrying out the
      activities. It is important that the user attends the sessions in comfortable, sleeveless
      clothing, to allow the tool to slide smoothly through their upper limbs.

      Each session will consist of several exercises with their corresponding rest breaks described
      in the Intervention Protocol. Each session attendance will be recorded following an
      attendance record model created for the occasion.

      INTERVENTION PROTOCOL

      To carry out the intervention sessions, all participants will follow the same protocol for
      the use of INTORUS. It is a protocol created for the study of increasing difficulty in which
      the participants advance to a higher level once they have passed the lower level.

      EVALUATION

      The evaluations will be carried out prior to the start of treatment, at 20 weeks of treatment
      and at 40 weeks of treatment once the intervention program has concluded.

      The tools used to carry out the evaluation will be:

        -  Questionnaire of participating sociodemographic variables

        -  Pediatric Balanced Scale (PBS)

        -  Berg Balance Scale

        -  Harris test. Adaptation of the Harris Test of Lateral Dominance

        -  Single leg support time on a stable surface

        -  Satisfaction questionnaire for professionals

        -  Participant satisfaction questionnaire adapted to easy reading. The evaluations will be
           carried out by a professional external to the treatment to avoid bias.

      Once the intervention period is over, a questionnaire will be passed to the professionals
      participating in the study to assess the usefulness of the device, the degree of satisfaction
      with it and the usefulness of the therapies applied, and a satisfaction questionnaire for
      participants adapted for easy reading. to know the degree of satisfaction and usefulness of
      the tool on the part of the participants.

      TIMELINE

      The intervention consists of 40 treatment sessions lasting 45 minutes each with a frequency
      of 2 days a week in which the intervention protocol described in Annex 7 described above will
      be developed. (15 min from Intorus) Previously, the participants will receive a "session 0"
      in which they will carry out a first contact with the device.
    

Intervention name(s): INTORUS
Intervention type(s): Device
Intervention description(s): INTERVENTION PROTOCOL WITH INTORUS
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Down syndrome; psychomotoricity