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NCT Number: NCT07282704

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

M Jose Vaamonde Fariñas

CONTACT

[email protected]

+34 981770056

Noemi Dobaño García

CONTACT

[email protected]

+34 981770056

Sponsors and collaborators

Lead sponsor

Fundación Hospitalarias Betanzos

Other

Registry information

Official study title

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

Acronym: Falls_Di

Important dates

Study start
2026
Primary completion
2026
Study completion
2027
First posted
Dec 15, 2025
Registry last updated
Dec 15, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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