An observational study in Falls, Intellectual Disabilities (F70-F79) and Risk Factors, sponsored by Fundación Hospitalarias Betanzos. Recruiting at 1 site in Spain. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-01.
Sponsored by Fundación Hospitalarias Betanzos · Observational
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.
387 studies on the registry are indexed under Intellectual Disability; 105 are open to participants now.
This study's planned enrollment of 600 is above the median of 150 across 125 observational studies indexed under Intellectual Disability.
Browse Intellectual Disability studies →This is the only study on the registry with Fundación Hospitalarias Betanzos as lead sponsor.
Counted across the registry records on this site, refreshed daily.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Time frame: 1 year
Sociodemographic variables
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.
Time frame: Baseline
Associated comorbidities
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.
Time frame: Baseline
Gait Disturbances
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.
Time frame: Baseline
Dynamic Balance
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.
Time frame: Baseline
Ability to overcome obstacles on the ground
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.
Time frame: Baseline
Stability limits
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.
Time frame: Baseline
Standardized measurement of balance
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.
Time frame: Baseline
Walking Ability
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.
Time frame: Baseline
Plan to share: Undecided — 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.
Ran from Jan 2026 to primary completion in May 2026, 4 months.
Of 47 non-industry observational studies under Intellectual Disability, half reached primary completion within 59 months of starting (the median), counting those still running; a quarter within 19 and three quarters within 203. This study's 4 months is below that.
Counting every sponsor, half of 48 studies reached it within 59 months; a quarter within 19 and three quarters within 203.
How these figures are worked out, and which studies are left out of them.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.