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

NCT ID: NCT07282704

Last Updated: 2025-12-15

Study Results

Results pending

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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Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

900 participants

Study Classification

OBSERVATIONAL

Study Start Date

2026-01-01

Study Completion Date

2027-04-30

Brief Summary

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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.

Detailed Description

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Conditions

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Falls Intellectual Disabilities (F70-F79) Risk Factors

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

* 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.

Exclusion Criteria

* 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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Fundación Hospitalarias Betanzos

OTHER

Sponsor Role lead

Responsible Party

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Noemi Dobaño García

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Fundación Hospitalarias Betanzos

Betanzos, A Coruña, Spain

Site Status

Countries

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Spain

Central Contacts

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Noemi Dobaño García

Role: CONTACT

+34 981770056

M Jose Vaamonde Fariñas

Role: CONTACT

+34 981770056

Facility Contacts

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Noemi Dobaño García

Role: primary

+34981770056

References

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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

Reference Type BACKGROUND

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

Reference Type 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.

Reference Type BACKGROUND
PMID: 32945091 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 19642712 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 23106830 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 24029799 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 26107855 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 23167484 (View on PubMed)

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

Reference Type BACKGROUND

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

Reference Type 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.

Reference Type BACKGROUND

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

Reference Type 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.

Reference Type BACKGROUND
PMID: 38350666 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 22018534 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 25105568 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 38154438 (View on PubMed)

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

Reference Type 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.

Reference Type BACKGROUND

Other Identifiers

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2025/423Falls.Di

Identifier Type: -

Identifier Source: org_study_id

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