Skip to content

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

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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07282704
Acronym
Falls_Di
Enrollment
600
Registered
2025-12-15
Start date
2026-01-01
Completion date
2027-04-30
Last updated
2026-09-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

Falls, Risk Factor, Intellectual Disability, Predictive Equation

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.

Interventions

None listed

Sponsors

Fundación Hospitalarias Betanzos
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Falls1 yearAccidental 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.

Secondary

MeasureTime frameDescription
Sociodemographic variablesBaselineSociodemographic 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.
Associated comorbiditiesBaselineInformation 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.
Gait DisturbancesBaselineThe 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.
Dynamic BalanceBaselineTo 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.
Ability to overcome obstacles on the groundBaselineTo 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.
Stability limitsBaselineTo 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.
Standardized measurement of balanceBaselineThe 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.
Walking AbilityBaselineThe 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.

Countries

Spain

Contacts

CONTACTNoemi Dobaño García
noemialba.dobano@fundacionhospitalarias.org+34 981770056
CONTACTM Jose Vaamonde Fariñas
mariajose.vaamonde@fundacionhospitalarias.org+34 981770056

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Sep 2, 2026