Motor Intervention Whit the Intorus Tool on Children With Down Syndrome

Influence of Motor Intervention With the Intorus Tool on the Psychomotor Development of Children With Down Syndrome

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.

Study Overview

• Status: Completed
• Conditions: Down Syndrome
• Intervention / Treatment: Device: INTORUS

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.

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Caceres, Spain, 10001
    • Blanca Gonzalez Sanchez

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 4 years to 18 years (Child, Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: experimental group; Group that will receive the intervention sessions using the Intorus tool	Device: INTORUS; INTERVENTION PROTOCOL WITH INTORUS
No Intervention: control group; Group that will receive the intervention sessions without using the Intorus tool

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Pediatric Balanced Scale	The Pediatric Balance Scale is a modified version of the Berg Balance Scale that is used to assess functional balance skills in school-aged children. The scale consists of 14 items that are scored from 0 points (lowest function) to 4 points (highest function) with a maximum score of 56 points	Before starting the interventions, at 3 months and at 6 months at the end of the study.
Change in Berg Equilibrium Scale	Scale for measuring balance in people over 15 years of age. The Berg Balance Scale (BBS) is used to objectively determine a patient's ability (or inability) to safely balance during a series of predetermined tasks. It is a 14 item list with each item consisting of a five-point ordinal scale ranging from 0 to 4, with 0 indicating the lowest level of function and 4 the highest level of function and takes approximately 20 minutes to complete. It does not include the assessment of gait.	Before starting the interventions, at 3 months and at 6 months at the end of the study.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Harris test	Scale for assessing lateralisation. In this way, it is possible to find out whether the child has a rightward, leftward, ambidextrous, incomplete, crossed or opposite laterality dominance.	Before starting the interventions, at 3 months and at 6 months at the end of the study.

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
PROFESSIONAL SATISFACTION	Questionnaire to measure the degree of satisfaction of the professionals participating in the study with the use of the tool.	through study completion, an average of 5 months
PARTICIPANTS SATISFACTION	Questionnaire to measure the degree of satisfaction of the participants in the study with the use of the tool.	through study completion, an average of 5 months

Collaborators and Investigators

• Sponsor: University of Extremadura
• Investigators: Principal Investigator: BLANCA GONZÁLEZ SÁNCHEZ, DOCTOR, UNIERSIDAD DE EXTREMADURA

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2023
• Primary Completion (Actual): June 30, 2023
• Study Completion (Actual): July 31, 2023

Study Registration Dates

• First Submitted: January 30, 2023
• First Submitted That Met QC Criteria: February 21, 2023
• First Posted (Actual): February 22, 2023

Study Record Updates

• Last Update Posted (Estimated): December 1, 2023
• Last Update Submitted That Met QC Criteria: November 30, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Keywords: Down syndrome; psychomotoricity
• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Neurologic Manifestations; Neurobehavioral Manifestations; Disease; Congenital Abnormalities; Genetic Diseases, Inborn; Intellectual Disability; Abnormalities, Multiple; Chromosome Disorders; Syndrome; Down Syndrome
• Other Study ID Numbers: ISD2023

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No