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

NCT07282704 | Not Yet Recruiting

• 1 other identifier: 2025/423Falls.Di
• Study Type: observational
• Target: 900
• Locations: 1 country
• Sites: 1

Brief 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. 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. 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.

Conditions

Falls; Intellectual Disabilities (F70-F79); Risk Factors

Keywords

Falls; Risk Factor; Intellectual Disability; Predictive Equation

Outcome Measures

Primary Outcomes (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.

  1 year

Secondary Outcomes (8)

• Sociodemographic variables

  Baseline

• Associated comorbidities

  Baseline

• Gait Disturbances

  Baseline

• Dynamic Balance

  Baseline

• Ability to overcome obstacles on the ground

  Baseline

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• Diagnosis of intellectual disability (all degrees of severity: mild, moderate, severe, and profound).
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Fundación Hospitalarias Betanzos: lead

Study Sites (1)

Fundación Hospitalarias Betanzos

Betanzos, A Coruña, 15300, Spain

Location

Related Publications (18)

• 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

  BACKGROUND

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

  BACKGROUND

• 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.

  PMID: 32945091 BACKGROUND

• 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.

  PMID: 19642712 BACKGROUND

• 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.

  PMID: 23106830 BACKGROUND

• 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.

  PMID: 24029799 BACKGROUND

• 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.

  PMID: 26107855 BACKGROUND

• 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.

  PMID: 23167484 BACKGROUND

• 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

  BACKGROUND

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

  BACKGROUND

• 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.

  BACKGROUND

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

  BACKGROUND

• 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.

  PMID: 38350666 BACKGROUND

• 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.

  PMID: 22018534 BACKGROUND

• 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.

  PMID: 25105568 BACKGROUND

• Beerse M, Alam T, Wu J. Dynamic gait stability in children with and without Down syndrome during overground walking. Clin Biomech (Bristol). 2024 Jan;111:106163. doi: 10.1016/j.clinbiomech.2023.106163. Epub 2023 Dec 26.

  PMID: 38154438 BACKGROUND

• Imserso. Instituto de Mayores y Servicios Sociales. Base Estatal de datos de personas con discapacidad. Actualización de Diciembre de 2020. Avaliable in: https://www.imserso.es/InterPresent1/groups/imserso/documents/binario/bdepcd_2020.pdf

  BACKGROUND

• Asociación Americana de Discapacidades Intelectuales y del Desarrollo. AAIDD. Discapacidad Intelectual: Definición, clasificación y sistemas de apoyo. 11.a ed. Madrid: Alianza Editorial; 2011.

  BACKGROUND

MeSH Terms

Conditions

Intellectual Disability

Condition Hierarchy (Ancestors)

Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurodevelopmental Disorders; Mental Disorders

Central Study Contacts

Noemi Dobaño García

CONTACT

+34 981770056; noemialba.dobano@fundacionhospitalarias.org

M Jose Vaamonde Fariñas

CONTACT

+34 981770056; mariajose.vaamonde@fundacionhospitalarias.org

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 20, 2025
• First Posted: December 15, 2025
• Study Start: January 1, 2026
• Primary Completion: March 30, 2026
• Study Completion (Estimated): April 30, 2027
• Last Updated: December 15, 2025

Record last verified: 2025-12

Locations

ES (1)