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

December 1, 2025 updated by: Noemi Dobaño García, Fundación Hospitalarias Betanzos

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.

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.

Study Overview

Status

Not yet recruiting

Conditions

Study Type

Observational

Enrollment (Estimated)

900

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

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.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Falls
Time Frame: 1 year
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Sociodemographic variables
Time Frame: Baseline
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.
Baseline
Associated comorbidities
Time Frame: Baseline

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.
Baseline
Gait Disturbances
Time Frame: Baseline
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.
Baseline
Dynamic Balance
Time Frame: Baseline
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.
Baseline
Ability to overcome obstacles on the ground
Time Frame: Baseline
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.
Baseline
Stability limits
Time Frame: Baseline
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.
Baseline
Standardized measurement of balance
Time Frame: Baseline
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.
Baseline
Walking Ability
Time Frame: Baseline
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.
Baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fundación Hospitalarias Betanzos

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

January 1, 2026

Primary Completion (Estimated)

March 30, 2026

Study Completion (Estimated)

April 30, 2027

Study Registration Dates

First Submitted

November 20, 2025

First Submitted That Met QC Criteria

December 1, 2025

First Posted (Actual)

December 15, 2025

Study Record Updates

Last Update Posted (Actual)

December 15, 2025

Last Update Submitted That Met QC Criteria

December 1, 2025

Last Verified

December 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2025/423Falls.Di

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

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.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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