Down SyndromeNCT05740046
Motor Intervention Whit the Intorus Tool on Children With Down Syndrome
A study testing INTORUS in people with Down Syndrome, run by University of Extremadura at 1 site in Spain.
Trial 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… Read more about this study
- Who is it for?
- Ages 4 to 18 years
- Conditions the study is for
- Down Syndrome
- What is being tested?
- INTORUS
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteSpain
- Study dates
- 1 Feb 2023to 31 Jul 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Users with Down Syndrome
- Ages between 4 and 18 years.
- Informed consent signed by parents/guardians.
Who cannot join
- Users without Down Syndrome.
- Under 4 years and over 18 years
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read more
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.
Read the 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.
- Conditions
- Down Syndrome
- Being tested
- INTORUS
- Keywords
- Down syndrome, psychomotoricity
- Medical subject headings
- Down Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
INTORUSDevice
INTERVENTION PROTOCOL WITH INTORUS
| Study group | Role | What they receive |
|---|---|---|
| experimental group | Experimental | Group that will receive the intervention sessions using the Intorus tool Receives: Device: INTORUS |
| control group | No intervention | Group that will receive the intervention sessions without using the Intorus tool |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
Measured: Before starting the interventions, at 3 months and at 6 months at the end of the study.
Secondary outcomes (1)
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.
Measured: Before starting the interventions, at 3 months and at 6 months at the end of the study.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Feb 2023
- Study start1 Feb 2023
- Primary completion30 Jun 2023
- Study completion31 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Down SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Extremadura
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Blanca González Sanchez, University of Extremadura
- Investigators
- BLANCA GONZÁLEZ SÁNCHEZ, DOCTOR, Principal investigator, UNIERSIDAD DE EXTREMADURA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05740046
- Sponsor's protocol ID
- ISD2023
- Status last verified
- Nov 2023
- First submitted
- 30 Jan 2023
- Last updated
- 1 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Motor Intervention With the Intorus Tool on the Psychomotor Development of Children With Down Syndrome
- ClinicalTrials.gov ID
- NCT05740046
- Acronym / sponsor ID
- ISD2023
- Conditions
- Down Syndrome
- Keywords
- Down syndrome, psychomotoricity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University of ExtremaduraUniversity, hospital or other
- Study start
- 1 Feb 2023 (actual)
- Primary completion
- 30 Jun 2023 (actual)
- Study completion
- 31 Jul 2023 (actual)
- First posted
- 22 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| experimental group | Experimental | Device: INTORUSGroup that will receive the intervention sessions using the Intorus tool |
| control group | No intervention | –Group that will receive the intervention sessions without using the Intorus tool |
Who may qualify
- Ages
- 4 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Users with Down Syndrome
- Ages between 4 and 18 years.
- Informed consent signed by parents/guardians.
Key exclusion criteria (2 listed)
- Users without Down Syndrome.
- Under 4 years and over 18 years
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| INTORUSINTERVENTION PROTOCOL WITH INTORUS | Device | experimental group |
Primary outcome
Change in Pediatric Balanced Scale
Time frame: Before starting the interventions, at 3 months and at 6 months at the end of the study.
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
Change in Berg Equilibrium Scale
Time frame: Before starting the interventions, at 3 months and at 6 months at the end of the study.
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.
1 secondary outcome
Change in Harris test
Time frame: Before starting the interventions, at 3 months and at 6 months at the end of the study.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Dec 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
BLANCA GONZÁLEZ SÁNCHEZ, DOCTOR principal investigator
UNIERSIDAD DE EXTREMADURA
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing INTORUS in people with Down Syndrome, run by University of Extremadura at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Pediatric Balanced Scale (time frame: Before starting the interventions, at 3 months and at 6 months at the end of the study.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Dec 2023.