Motor Intervention Whit the Intorus Tool on Children With Down Syndrome

NCT05740046 | Completed

• 1 other identifier: ISD2023
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Down Syndrome

Keywords

Down syndrome; psychomotoricity

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• Change in Harris test

  Before starting the interventions, at 3 months and at 6 months at the end of the study.

Other Outcomes (2)

• PROFESSIONAL SATISFACTION

  through study completion, an average of 5 months

• PARTICIPANTS SATISFACTION

  through study completion, an average of 5 months

Study Arms (2)

experimental group

EXPERIMENTAL

Group that will receive the intervention sessions using the Intorus tool

Device: INTORUS

control group

NO INTERVENTION

Group that will receive the intervention sessions without using the Intorus tool

Interventions

INTORUS DEVICE

INTERVENTION PROTOCOL WITH INTORUS

experimental group

Eligibility Criteria

• Age: 4 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Users with Down Syndrome
• Ages between 4 and 18 years.
• Informed consent signed by parents/guardians.

You may not qualify if:

• Users without Down Syndrome.
• Under 4 years and over 18 years

Sponsors & Collaborators

• University of Extremadura: lead

Study Sites (1)

Blanca Gonzalez Sanchez

Cáceres, 10001, Spain

Location

MeSH Terms

Conditions

Down Syndrome

Condition Hierarchy (Ancestors)

Intellectual Disability; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Abnormalities, Multiple; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Chromosome Disorders; Genetic Diseases, Inborn

Study Officials

• BLANCA GONZÁLEZ SÁNCHEZ, DOCTOR

  UNIERSIDAD DE EXTREMADURA

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: DOCTOR

Study Record Dates

• First Submitted: January 30, 2023
• First Posted: February 22, 2023
• Study Start: February 1, 2023
• Primary Completion: June 30, 2023
• Study Completion: July 31, 2023
• Last Updated: December 1, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)