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NCT05740046

Motor Intervention Whit the Intorus Tool on Children With Down Syndrome

Completed NA Last updated 1 December 2023
What this trial tests

NA trial testing INTORUS in Down Syndrome in 30 participants. Completed in 31 July 2023.

Timeline
1 February 2023
Primary endpoint
30 June 2023
31 July 2023

Quick facts

Lead sponsorUniversity of Extremadura
PhaseNA
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingtriple
Primary purposetreatment
Enrollment30
Start date1 February 2023
Primary completion30 June 2023
Estimated completion31 July 2023
Sites1 location across Spain

Drugs / interventions tested

Conditions studied

Sponsor

University of Extremadura

Who can join

Adults 4 to 18, any sex, with Down Syndrome. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

Verify or expand the search:

Other trials of INTORUS

Trials testing the same drug.

Other recruiting trials for Down Syndrome

Currently open trials in the same condition.

Other University of Extremadura trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

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Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing