Motor Intervention Whit the Intorus Tool on Children With Down Syndrome
NCT ID: NCT05740046
Last Updated: 2023-12-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
30 participants
INTERVENTIONAL
2023-02-01
2023-07-31
Brief Summary
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\- 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
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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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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experimental group
Group that will receive the intervention sessions using the Intorus tool
INTORUS
INTERVENTION PROTOCOL WITH INTORUS
control group
Group that will receive the intervention sessions without using the Intorus tool
No interventions assigned to this group
Interventions
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INTORUS
INTERVENTION PROTOCOL WITH INTORUS
Eligibility Criteria
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Inclusion Criteria
* Ages between 4 and 18 years.
* Informed consent signed by parents/guardians.
Exclusion Criteria
* Under 4 years and over 18 years
4 Years
18 Years
ALL
No
Sponsors
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University of Extremadura
OTHER
Responsible Party
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Blanca González Sanchez
DOCTOR
Principal Investigators
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BLANCA GONZÁLEZ SÁNCHEZ, DOCTOR
Role: PRINCIPAL_INVESTIGATOR
UNIERSIDAD DE EXTREMADURA
Locations
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Blanca Gonzalez Sanchez
Cáceres, , Spain
Countries
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Other Identifiers
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ISD2023
Identifier Type: -
Identifier Source: org_study_id