AzTrials
AzTrials

FallsFalls_DiNCT07282704

Falls In Spanish People With Intellectual Disabilities: Risk Factors And Predictive Equation. Falls.Di Study

An observational study of Falls and Intellectual Disabilities (F70-F79), run by Fundación Hospitalarias Betanzos at 1 site in Spain.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

This multicenter study aims to understand the specific risk factors for falls in Spanish people with intellectual disabilities in order to design an instrument to assess the risk of future falls in this population. Read more about this study

Who is it for?
Ages 18 years and older
How many people
600 participants
Where
1 siteSpain
Study dates
1 Jan 2026to 30 Apr 2027
Phase
Observational
Are there results?
Not yet: the study is under way

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 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: The sample will consist of people with intellectual disabilities (who meet the inclusion criteria described above) who reside in the centers belonging to the Fundación Hospitalarias España.

Who may be able to join

  • Diagnosis of intellectual disability (all degrees of severity: mild, moderate, severe, and profound).
  • 18 years of age or older.
  • The participant must be able to stand and walk independently or with technical/personal aids.
  • Sign the informed consent form to participate.

Who cannot join

  • If the participant has poorly controlled epilepsy with seizures or absences that cause falls.
  • Wheelchair use.
  • Other musculoskeletal, neurological, or trauma conditions that contraindicate participation in the study.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Noemi Dobaño García contact

+34 981770056

noemialba.dobano@fundacionhospitalarias.org

M Jose Vaamonde Fariñas contact

+34 981770056

mariajose.vaamonde@fundacionhospitalarias.org

Spain1 site, 1 recruiting

  • Fundación Hospitalarias Betanzos

    Betanzos, A Coruña, 15300

    Noemi Dobaño García, +34981770056, noemialba.dobano@fundacionhospitalarias.org

    Recruiting

Other trials in Spain

About this study

Official title: Falls In Spanish People With Intellectual Disabilities: Analysis Of Risk Factors And Predictive Equation. Multicenter Study (Falls.Di)

This multicenter study aims to understand the specific risk factors for falls in Spanish people with intellectual disabilities in order to design an instrument to assess the risk of future falls in this population.

To this end, a prospective cohort study will be conducted in a sample of people with intellectual disabilities who meet predefined inclusion criteria from the Fundación Hospitalarias España centers that care for people with intellectual disabilities.

Read more

Participants' medical records will be reviewed for sociodemographic variables and associated comorbidities, and gait and balance will be assessed to identify potential risk factors. The number of falls experienced by participants will be monitored for 12 months.

After the observation period, a statistical analysis will be performed to identify the main risk factors in the sample. These factors will be used to model a mathematical equation predicting the number of future falls.

Keywords
Falls, Risk Factor, Intellectual Disability, Predictive Equation
Medical subject headings
Intellectual Disability

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Falls

    Accidental falls occurring to participants will be recorded for 12 months after the initial assessment. Falls resulting from seizures, fainting, and intentional pushing by other residents will be excluded.

    Measured: 1 year

Secondary outcomes (8)

  1. Sociodemographic variables

    Sociodemographic data such as age, sex and level of intellectual disability will be collected from the participants' medical history following the diagnostic criteria of the DSM-V.

    Measured: Baseline

  2. Associated comorbidities

    Information about the presence of the following comorbidities will be collected from participants' medical histories.

    The participant's medical record indicates whether or not they have the diseases listed here. If a disease is present, the researcher will note it in the data collection notebook as if the participant has that disease: heart problems, high blood pressure, visual and/or hearing problems, neurological diseases, origin of intellectual disability, diabetes, arthritis/arthrosis, hemiplegia/hemiparesis, use of orthopedic footwear, attention deficit, number and type of medication.

    Measured: Baseline

  3. Gait Disturbances

    The center's physiotherapist will assess the participant's gait. She will observe whether they shuffle their feet, keep their feet close together, or follow any established neurological pattern.

    Measured: Baseline

  4. Dynamic Balance

    To assess the participant's dynamic balance, the physiotherapist will ask the person to walk on mats, go up and down stairs, and go up and down ramps. If the participant is able to perform the requested action, it will be considered that the participant has good balance.

    Measured: Baseline

  5. Ability to overcome obstacles on the ground

    To assess the participant's ability to overcome obstacles on the ground, the physiotherapist will ask the person to try to cross an obstacle (like a fence) at 5, 10, 15 and 17 cm in height.

    Measured: Baseline

  6. Stability limits

    To assess the participant's stability limits, they will be asked to pick up an object that the physiotherapist will have placed on the floor. If the person is able to pick it up, it will be considered a successful attempt.

    Measured: Baseline

  7. Standardized measurement of balance

    The standardized Tinetti Test will be used to assess balance. The Tinetti test, also known as the Performance-Oriented Mobility Assessment (POMA), evaluates fall risk through two sections: balance and gait, using a hard, armless chair and a 4.5-meter walkway. The balance section assesses sitting balance, rising, standing with eyes open and closed, and turning, while the gait section evaluates walking speed, step symmetry, path, and trunk sway. A total score of 25 or less indicates an increased fall risk, with scores below 19 showing high risk.

    Measured: Baseline

  8. Walking Ability

    The standardized Timed Up and Go test will be used to assess walking ability. Any assistive device used for walking should be nearby. Regular footwear and customary walking aids should be used. The patient should walk to a line that is 3 meters (9.8 feet) away, turn around at the line, walk back to the chair, and sit down. The test ends when the patient's buttocks touch the seat.

    Measured: Baseline

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Dec 2025
  2. Study start1 Jan 2026
  3. Primary completion30 May 2026
  4. Study completion30 Apr 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
600 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07282704
Sponsor's protocol ID
2025/423Falls.Di
Acronym
Falls_Di
Status last verified
Aug 2026
First submitted
20 Nov 2025
Last updated
1 Sep 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided: Currently, the method for sharing the collected variables with other researchers outside the research team has not been defined. It is necessary to define the variables, format, and location for sharing them.

Publications

  • Dobaño N. Riesgo de caídas en personas con discapacidad intelectual: diseño y validación de un instrumento evaluador. 2022. Disponible en: https://ruc.udc.es/dspace/handle/2183/33311

  • Cameron AC, Trivedi PK. Regression Analysis of Count Data. Cambridge: Cambridge University Press; 2013. 597 p.

  • Pope J, Truesdale M, Brown M. Risk factors for falls among adults with intellectual disabilities: A narrative review. J Appl Res Intellect Disabil. 2021 Jan;34(1):274-285. doi: 10.1111/jar.12805. Epub 2020 Sep 17.

    PubMed 32945091

  • Chiba Y, Shimada A, Yoshida F, Keino H, Hasegawa M, Ikari H, Miyake S, Hosokawa M. Risk of fall for individuals with intellectual disability. Am J Intellect Dev Disabil. 2009 Jul;114(4):225-36. doi: 10.1352/1944-7558-114.4:225-236.

    PubMed 19642712

  • Smulders E, Enkelaar L, Weerdesteyn V, Geurts AC, van Schrojenstein Lantman-de Valk H. Falls in older persons with intellectual disabilities: fall rate, circumstances and consequences. J Intellect Disabil Res. 2013 Dec;57(12):1173-82. doi: 10.1111/j.1365-2788.2012.01643.x. Epub 2012 Oct 29.

    PubMed 23106830

  • Enkelaar L, Smulders E, van Schrojenstein Lantman-de Valk H, Weerdesteyn V, Geurts AC. Prospective study on risk factors for falling in elderly persons with mild to moderate intellectual disabilities. Res Dev Disabil. 2013 Nov;34(11):3754-65. doi: 10.1016/j.ridd.2013.07.041. Epub 2013 Sep 9.

    PubMed 24029799

  • Salb J, Woodward C, Offenhausser J, Becker C, Sieber C, Freiberger E. Prevalence and Characteristics of Falls in Adults with Intellectual Disability Living in a Residential Facility: A Longitudinal Study [PreFallID]. Intellect Dev Disabil. 2015 Jun;53(3):228-39. doi: 10.1352/1934-9556-53.3.228.

    PubMed 26107855

  • Hsieh K, Rimmer J, Heller T. Prevalence of falls and risk factors in adults with intellectual disability. Am J Intellect Dev Disabil. 2012 Nov;117(6):442-54. doi: 10.1352/1944-7558-117.6.442.

    PubMed 23167484

  • Novell Alsina R, Rueda Quitllet P, Salvador Carulla L, Forgas Farre E. Capítulo VI: Utilización de fármacos en las alteraciones mentales y/o de la conducta en personas con Discapacidad Intelectual. ¿Qué debemos saber? En: Salud mental y alteraciones de la conducta en las personas con discapacidad intelectual Guía práctica para técnicos y cuidadores

  • Novell-Alsina R, Nadal M, Smilges A, Pasqual J, Pujol J. Informe Séneca. Envelliment i Discapacitat Intellectual a Catalunya. 2008.

  • Novell-Alsina R. Conocer la salud física. En: Rueda Quitllet P, Novell-Alsina R, editores. Conductas que nos preocupan en personas con discapacidad intelectual y del desarrollo: ¿Qué debes saber? ¿Qué debes hacer? Madrid: Confederación Plena Inclusión España; 2021. p. 69-98.

  • Romera CG. Envejecimiento y personas con discapacidad intelectual. Guía de recursos y actividades.

  • Masso-Ortigosa N, Rey-Abella F, Gutierrez-Vilahu L, Mila R, Guerra-Balic M, Oviedo GR. Analysis of the centre of pressure in bipedal stance among individuals with and without intellectual disabilities, individuals with Down syndrome and dancers with Down syndrome. J Intellect Disabil Res. 2024 May;68(5):524-536. doi: 10.1111/jir.13127. Epub 2024 Feb 13.

    PubMed 38350666

  • Enkelaar L, Smulders E, van Schrojenstein Lantman-de Valk H, Geurts AC, Weerdesteyn V. A review of balance and gait capacities in relation to falls in persons with intellectual disability. Res Dev Disabil. 2012 Jan-Feb;33(1):291-306. doi: 10.1016/j.ridd.2011.08.028. Epub 2011 Oct 21.

    PubMed 22018534

  • Almuhtaseb S, Oppewal A, Hilgenkamp TI. Gait characteristics in individuals with intellectual disabilities: a literature review. Res Dev Disabil. 2014 Nov;35(11):2858-83. doi: 10.1016/j.ridd.2014.07.017. Epub 2014 Aug 7.

    PubMed 25105568

Questions about this trial

What is this clinical trial studying?

An observational study of Falls and Intellectual Disabilities (F70-F79), run by Fundación Hospitalarias Betanzos 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 4 inclusion and 3 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: looking for participants now, as of the sponsor's last update on 1 Sep 2026. 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?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Noemi Dobaño García (+34 981770056, noemialba.dobano@fundacionhospitalarias.org), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Falls (time frame: 1 year). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07282704, which also lists 18 linked publications.

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 Sep 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in