Frailty SyndromeVIRTO-FRAILNCT07060677
Effectiveness of Immersive Virtual Reality Combined With Occupational Therapy in Reducing Fall Risk and Frailty Among Older Adults
A study testing Inmersive Virtual Reality and Conventional occupational therapy sessions in people with Frailty Syndrome and Older Adults, Balance, run by Universidad Rey Juan Carlos at 2 sites in Spain.
Trial summary
Population aging is a growing global phenomenon that poses significant challenges to healthcare systems, particularly in preventing falls and managing frailty among older adults. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Frailty Syndrome, Older Adults, Balance, Fall Prevention in Healthy Aging
- What is being tested?
- Inmersive Virtual Reality and Conventional occupational therapy sessions
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 2 sitesSpain
- Study dates
- 15 Sep 2025to Nov 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Individuals aged 65 years or older
- Regularly attending rehabilitation treatment at the Bouco Madrid Ferraz Residence
- Having the ability to walk with or without assistive devices
- Presenting sufficient cognitive capacity to understand instructions (score ≥ 24 on the MMSE)
- Agreeing to participate voluntarily
- Signing the informed consent form.
Who cannot join
- Having a diagnosis of a severe neurological disease (such as advanced Parkinson's disease or ALS, among others)
- Having a history of epilepsy or seizures (due to potential adverse effects with VR)
- Experiencing cardiovascular instability or having a medical contraindication for physical activity
- Presenting vestibular disorders
- Participating in other similar intervention programs during the same period
- Being unable to use virtual reality glasses due to intolerance or dizziness
- Not agreeing to participate voluntarily in the study and/or not signing the informed consent form.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Spain2 sites
Universidad Rey Juan Carlos
Alcorcón, Marid, 28922
Cristina García-Bravo, 914884877, cristina.bravo@urjc.es
Residencia Bouco Madrid Ferraz
Madrid, 28008
Melissa Helen Zegarra-Ramos, 915442248, terapia.madridferraz@emeis.com
About this study
Population aging is a growing global phenomenon that poses significant challenges to healthcare systems, particularly in preventing falls and managing frailty among older adults. Falls remain a leading cause of morbidity and mortality in this population, affecting approximately one-third of individuals over 65 each year. At the same time, frailty syndrome (FS)-a clinical condition marked by progressive decline in physical and cognitive function-significantly increases the risk of falls, disability, and dependency. Pre-frailty, an intermediate and reversible stage, offers a key opportunity for preventive interventions.
Scientific evidence supports the effectiveness of interdisciplinary approaches to address frailty and fall prevention. In this context, occupational therapy plays a central role by promoting functional autonomy through meaningful activities. However, traditional approaches may be limited in individuals with low motivation or mild cognitive impairment. Therefore, integrating innovative technologies such as immersive virtual reality (IVR) emerges as a promising therapeutic strategy.
Read more
IVR enables users to interact with simulated three-dimensional environments, enhancing cognitive stimulation, motor training, and treatment adherence. Modern devices like the Meta Quest 3 headsets provide accessible, safe, and adaptable immersive experiences, with reported benefits in balance, gait, attention, and motivation. Nonetheless, no studies to date have specifically evaluated the effectiveness of this technology when combined with conventional occupational therapy to reduce fall risk and frailty in older adults.
This project proposes a pilot randomized controlled trial (RCT), lasting 5 months, using a single-blind, parallel-group design. It will be conducted at the Bouco Madrid Ferraz Residential Center (Madrid, Spain), following CONSORT 2010 methodological guidelines. The primary aim is to assess the efficacy of a combined intervention using IVR through Meta Quest 3 headsets and occupational therapy, compared to conventional occupational therapy alone, in reducing fall risk, improving frailty status, enhancing quality of life, and increasing rehabilitation motivation in older adults.
The sample will include 30 participants (15 per group), selected based on specific inclusion and exclusion criteria. Participants will be randomly assigned to a control group (CG), receiving standard occupational therapy, or to an experimental group (EG), receiving a combined intervention of occupational therapy and IVR using the Kinesix XR platform, which is designed to enhance balance.
The intervention will last 8 weeks, with two one-hour sessions per week. The experimental group will receive 30 minutes of occupational therapy and 30 minutes of IVR per session. Assessments will be conducted at baseline, post-intervention, and at a 3-month follow-up using validated scales to measure fall risk, balance, frailty level, quality of life, and satisfaction.
Data will be pseudonymized, statistically analyzed using SPSS, and managed in compliance with the European General Data Protection Regulation (EU 2016/679). The small sample size reflects the exploratory nature of the study, aimed at assessing feasibility, safety, and preliminary outcomes prior to conducting a larger-scale trial.
Ultimately, this project aims to provide initial evidence on an innovative intervention for older adults by integrating digital tools with conventional therapeutic approaches. If proven effective, the VIRTO-FRAIL model could lay the groundwork for new strategies in geriatric rehabilitation and fall prevention.
- Being tested
- Inmersive Virtual Reality, Conventional occupational therapy sessions
- Keywords
- Inmersive Virtual Reality, Occupational Therapy, Frailty Sindrome, Fall Prevention, Older Adults, Pre-Frailty, Quality of Life
- Medical subject headings
- Frailty
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Inmersive Virtual RealityProcedure or surgery
Participants will receive a intervention of immersive virtual reality using Meta Quest 3 and the Kinesix XR platform. Sessions will take place twice per week for 8 weeks. The IVR component will focus on balance and mobility through interactive, immersive environments designed to enhance engagement, adherence, and functional outcomes. This multimodal approach aims to reduce fall risk and frailty while improving motivation and quality of life in older adults.
Conventional occupational therapy sessionsProcedure or surgery
Participants will receive conventional occupational therapy only, with sessions conducted twice per week for 8 weeks. The intervention will focus on cognitive stimulation, manipulative skill training, and psychomotor exercises, all adapted to the functional level of each participant. Activities aim to maintain or improve autonomy, balance, and coordination, following established occupational therapy guidelines for older adults. No immersive virtual reality or digital technology will be included in this group. This control condition allows for comparison with the experimental group to evaluate the added value of immersive virtual reality in fall risk and frailty reduction.
| Study group | Role | What they receive |
|---|---|---|
| Experimental Group (EG) | Experimental | Experimental Group (EG), which received therapy with Inmersive Virtual Reality, plus their conventional occupational therapy sessions. Receives: Procedure: Inmersive Virtual Reality; Procedure: Conventional occupational therapy sessions |
| Control Group (CG) | Active comparator | Control Group (CG), which received their usual sessions of conventional occupational therapy. Receives: Procedure: Conventional occupational therapy sessions |
What is being measured
The primary outcome is the main question the study is designed to answer.
Functional Independence Measure (FIM)
An instrument that assesses the level of functional independence in activities of daily living. It provides information primarily on motor and cognitive performance through 18 items. Each item is scored from 1 to 7, with higher scores indicating greater functional independence. The assessment is conducted through task observation and interview.
Measured: Pre-intervention, post-intervention (up to 1 week) and follow-up (3-month)
Functional Reach Test
This test measures the maximum distance an individual can shift their center of gravity towards the limits of their base of support. In a relaxed standing posture, with feet hip-width apart, the participant is asked to flex the shoulder to 90 degrees and keep the hand extended. They must then reach forward as far as possible. The examiner records the furthest distance the center of gravity is displaced. Two practice trials and three recorded trials are conducted, with the average of the three being the final score. The result is recorded in centimeters.
Measured: Pre-intervention, post-intervention (up to 1 week) and follow-up (3 month)
Timed 'Up and Go' (TUG)
This test measures the time it takes a person to rise from a chair, walk 3 meters, turn around, return to the chair, and sit down again. It evaluates balance and gait speed. The score is recorded in seconds.
Measured: Pre-intervention, post-intervention (up to 1 week) and follow-up (3-month)
Clinical Frailty Scale (CFS)
A clinical tool used to assess the level of frailty in older adults. It is based on a 9-point scale, where patients are classified from 1 (very fit) to 9 (terminally ill), reflecting increasing severity of frailty. Higher scores indicate worse outcomes, representing greater vulnerability and dependency. The evaluation incorporates physical and cognitive function, as well as the level of dependency, to estimate a patient's vulnerability to stressors.
Measured: Pre-intervention, post-intervention (up to 1 week) and follow-up (3-month)
Kinesix Virtual Reality Therapeutics© Functional Assessment Scale
Designed to objectively measure and analyze a person's performance in specific tasks. This tool evaluates upper limb reach, balance, and other key functional capacities, providing valuable information for establishing a starting point and tracking patient progress over time.
Scores on the Kinesix VR Therapeutics© Functional Assessment Scale range from 0 to 100, with higher scores indicating better functional performance and a more favorable outcome. A score of 0 reflects minimal or no functional ability, while a score of 100 indicates optimal or fully restored function.
This scale is intended for use by trained clinicians and therapists to monitor patient progress over time, assess the effectiveness of VR interventions, and support individualized treatment planning.
Measured: Pre-intervention, post-intervention (up to 1 week) and follow-up (3-month)
World Health Organization Quality of Life - BREF (WHOQOL-BREF)
A self-administered questionnaire that evaluates overall perception of quality of life and general health status. It consists of four domains: physical health, psychological health, social relationships, and environment. The WHOQOL-BREF consists of 26 items that measure four domains: Physical Health, Psychological Health, Social Relationships, and Environment. Each item is rated on a 5-point Likert scale, and domain scores are transformed to range from 0 to 100, in accordance with WHO scoring guidelines.
Higher scores on the WHOQOL-BREF indicate a better quality of life. A score of 0 represents the lowest possible quality of life in a domain, while a score of 100 reflects the highest possible perceived quality of life.
The WHOQOL-BREF provides a comprehensive yet efficient assessment of well-being and is validated across a wide range of cultures and populations.
Measured: Pre-intervention, post-intervention (up to 1 week) and follow-up (3-month)
Secondary outcomes (2)
Client Satisfaction Questionnaire (CSQ-8)
A self-administered questionnaire consisting of 8 items that assess satisfaction with the care and quality of services received, as well as how well the intervention met the patient's expectations. Responses are scored from 1 to 4, with a maximum score of 32; higher scores indicate greater satisfaction. The Spanish adaptation of the questionnaire has shown adequate psychometric properties and preserves the characteristics of the original version, making it suitable for assessing satisfaction with healthcare services in the Spanish population. The CSQ-8 will be administered to both treatment groups in this study.
Measured: Post-intervention (up to 1 week)
System Usability Scale (SUS)
A usability evaluation scale used to assess the effectiveness of virtual reality in healthcare settings. It includes 10 items that cover various aspects of the user's experience with the technology, such as ease of use, efficiency, and overall satisfaction. Responses range from "strongly agree" to "strongly disagree."
Measured: Post-intervention (up to 1 week)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2025
- Study start15 Sep 2025 (estimated)
- Primary completion25 Sep 2025 (estimated)
- Study completionNov 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Frailty SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Control Group (CG), which received their usual sessions of conventional occupational therapy, and an Experimental Group (EG), which received therapy with Inmersive Virtual Reality, plus their conventional occupational therapy sessions.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidad Rey Juan Carlos
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Cristina García-Bravo, Universidad Rey Juan Carlos
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07060677
- Sponsor's protocol ID
- 080520254252025
- Acronym
- VIRTO-FRAIL
- Status last verified
- Jul 2025
- First submitted
- 19 Jun 2025
- Last updated
- 16 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Immersive Virtual Reality Combined With Occupational Therapy in Reducing Fall Risk and Frailty Among Older Adults
- ClinicalTrials.gov ID
- NCT07060677
- Acronym / sponsor ID
- VIRTO-FRAIL / 080520254252025
- Keywords
- Inmersive Virtual Reality, Occupational Therapy, Frailty Sindrome, Fall Prevention, Older Adults, Pre-Frailty, Quality of Life
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Universidad Rey Juan CarlosUniversity, hospital or other
- Study start
- 15 Sep 2025 (estimated)
- Primary completion
- 25 Sep 2025 (estimated)
- Study completion
- Nov 2025 (estimated)
- First posted
- 11 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Population aging is a growing global phenomenon that poses significant challenges to healthcare systems, particularly in preventing falls and managing frailty among older adults. Falls remain a leading cause of morbidity and mortality in this population, affecting approximately one-third of individuals over 65 each year. At the same time, frailty syndrome (FS)-a clinical condition marked by progressive decline in physical and cognitive function-significantly increases the risk of falls, disability, and dependency. Pre-frailty, an intermediate and reversible stage, offers a key opportunity for preventive interventions.
Scientific evidence supports the effectiveness of interdisciplinary approaches to address frailty and fall prevention. In this context, occupational therapy plays a central role by promoting functional autonomy through meaningful activities. However, traditional approaches may be limited in individuals with low motivation or mild cognitive impairment. Therefore, integrating innovative technologies such as immersive virtual reality (IVR) emerges as a promising therapeutic strategy.
IVR enables users to interact with simulated three-dimensional environments, enhancing cognitive stimulation, motor training, and treatment adherence. Modern devices like the Meta Quest 3 headsets provide accessible, safe, and adaptable immersive experiences, with reported benefits in balance, gait, attention, and motivation. Nonetheless, no studies to date have specifically evaluated the effectiveness of this technology when combined with conventional occupational therapy to reduce fall risk and frailty in older adults.
This project proposes a pilot randomized controlled trial (RCT), lasting 5 months, using a single-blind, parallel-group design. It will be conducted at the Bouco Madrid Ferraz Residential Center (Madrid, Spain), following CONSORT 2010 methodological guidelines. The primary aim is to assess the efficacy of a combined intervention using IVR through Meta Quest 3 headsets and occupational therapy, compared to conventional occupational therapy alone, in reducing fall risk, improving frailty status, enhancing quality of life, and increasing rehabilitation motivation in older adults.
The sample will include 30 participants (15 per group), selected based on specific inclusion and exclusion criteria. Participants will be randomly assigned to a control group (CG), receiving standard occupational therapy, or to an experimental group (EG), receiving a combined intervention of occupational therapy and IVR using the Kinesix XR platform, which is designed to enhance balance.
The intervention will last 8 weeks, with two one-hour sessions per week. The experimental group will receive 30 minutes of occupational therapy and 30 minutes of IVR per session. Assessments will be conducted at baseline, post-intervention, and at a 3-month follow-up using validated scales to measure fall risk, balance, frailty level, quality of life, and satisfaction.
Data will be pseudonymized, statistically analyzed using SPSS, and managed in compliance with the European General Data Protection Regulation (EU 2016/679). The small sample size reflects the exploratory nature of the study, aimed at assessing feasibility, safety, and preliminary outcomes prior to conducting a larger-scale trial.
Ultimately, this project aims to provide initial evidence on an innovative intervention for older adults by integrating digital tools with conventional therapeutic approaches. If proven effective, the VIRTO-FRAIL model could lay the groundwork for new strategies in geriatric rehabilitation and fall prevention.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Control Group (CG), which received their usual sessions of conventional occupational therapy, and an Experimental Group (EG), which received therapy with Inmersive Virtual Reality, plus their conventional occupational therapy sessions.
| Arm | Type | Receives |
|---|---|---|
| Experimental Group (EG) | Experimental | Procedure: Inmersive Virtual Reality, Procedure: Conventional occupational therapy sessionsExperimental Group (EG), which received therapy with Inmersive Virtual Reality, plus their conventional occupational therapy sessions. |
| Control Group (CG) | Active comparator | Procedure: Conventional occupational therapy sessionsControl Group (CG), which received their usual sessions of conventional occupational therapy. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (6 listed)
- Individuals aged 65 years or older
- Regularly attending rehabilitation treatment at the Bouco Madrid Ferraz Residence
- Having the ability to walk with or without assistive devices
- Presenting sufficient cognitive capacity to understand instructions (score ≥ 24 on the MMSE)
- Agreeing to participate voluntarily
Key exclusion criteria (7 listed)
- Having a diagnosis of a severe neurological disease (such as advanced Parkinson's disease or ALS, among others)
- Having a history of epilepsy or seizures (due to potential adverse effects with VR)
- Experiencing cardiovascular instability or having a medical contraindication for physical activity
- Presenting vestibular disorders
- Participating in other similar intervention programs during the same period
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Inmersive Virtual RealityParticipants will receive a intervention of immersive virtual reality using Meta Quest 3 and the Kinesix XR platform. Sessions will take place twice per week for 8 weeks. The IVR component will focus on balance and mobility through interactive, immersive environments designed to enhance engagement, adherence, and functional outcomes. This multimodal approach aims to reduce fall risk and frailty while improving motivation and quality of life in older adults. | Procedure or surgery | Experimental Group (EG) |
| Conventional occupational therapy sessionsParticipants will receive conventional occupational therapy only, with sessions conducted twice per week for 8 weeks. The intervention will focus on cognitive stimulation, manipulative skill training, and psychomotor exercises, all adapted to the functional level of each participant. Activities aim to maintain or improve autonomy, balance, and coordination, following established occupational therapy guidelines for older adults. No immersive virtual reality or digital technology will be included in this group. This control condition allows for comparison with the experimental group to evaluate the added value of immersive virtual reality in fall risk and frailty reduction. | Procedure or surgery | Control Group (CG), Experimental Group (EG) |
Primary outcome
Functional Independence Measure (FIM)
Time frame: Pre-intervention, post-intervention (up to 1 week) and follow-up (3-month)
An instrument that assesses the level of functional independence in activities of daily living. It provides information primarily on motor and cognitive performance through 18 items. Each item is scored from 1 to 7, with higher scores indicating greater functional independence. The assessment is conducted through task observation and interview.
Functional Reach Test
Time frame: Pre-intervention, post-intervention (up to 1 week) and follow-up (3 month)
This test measures the maximum distance an individual can shift their center of gravity towards the limits of their base of support. In a relaxed standing posture, with feet hip-width apart, the participant is asked to flex the shoulder to 90 degrees and keep the hand extended. They must then reach forward as far as possible. The examiner records the furthest distance the center of gravity is displaced. Two practice trials and three recorded trials are conducted, with the average of the three being the final score. The result is recorded in centimeters.
Timed 'Up and Go' (TUG)
Time frame: Pre-intervention, post-intervention (up to 1 week) and follow-up (3-month)
This test measures the time it takes a person to rise from a chair, walk 3 meters, turn around, return to the chair, and sit down again. It evaluates balance and gait speed. The score is recorded in seconds.
Clinical Frailty Scale (CFS)
Time frame: Pre-intervention, post-intervention (up to 1 week) and follow-up (3-month)
A clinical tool used to assess the level of frailty in older adults. It is based on a 9-point scale, where patients are classified from 1 (very fit) to 9 (terminally ill), reflecting increasing severity of frailty. Higher scores indicate worse outcomes, representing greater vulnerability and dependency. The evaluation incorporates physical and cognitive function, as well as the level of dependency, to estimate a patient's vulnerability to stressors.
Kinesix Virtual Reality Therapeutics© Functional Assessment Scale
Time frame: Pre-intervention, post-intervention (up to 1 week) and follow-up (3-month)
Designed to objectively measure and analyze a person's performance in specific tasks. This tool evaluates upper limb reach, balance, and other key functional capacities, providing valuable information for establishing a starting point and tracking patient progress over time. Scores on the Kinesix VR Therapeutics© Functional Assessment Scale range from 0 to 100, with higher scores indicating better functional performance and a more favorable outcome. A score of 0 reflects minimal or no functional ability, while a score of 100 indicates optimal or fully restored function. This scale is intended for use by trained clinicians and therapists to monitor patient progress over time, assess the effectiveness of VR interventions, and support individualized treatment planning.
World Health Organization Quality of Life - BREF (WHOQOL-BREF)
Time frame: Pre-intervention, post-intervention (up to 1 week) and follow-up (3-month)
A self-administered questionnaire that evaluates overall perception of quality of life and general health status. It consists of four domains: physical health, psychological health, social relationships, and environment. The WHOQOL-BREF consists of 26 items that measure four domains: Physical Health, Psychological Health, Social Relationships, and Environment. Each item is rated on a 5-point Likert scale, and domain scores are transformed to range from 0 to 100, in accordance with WHO scoring guidelines. Higher scores on the WHOQOL-BREF indicate a better quality of life. A score of 0 represents the lowest possible quality of life in a domain, while a score of 100 reflects the highest possible perceived quality of life. The WHOQOL-BREF provides a comprehensive yet efficient assessment of well-being and is validated across a wide range of cultures and populations.
2 secondary outcomes
Client Satisfaction Questionnaire (CSQ-8)
Time frame: Post-intervention (up to 1 week)
System Usability Scale (SUS)
Time frame: Post-intervention (up to 1 week)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2025.
- Individual participant dataSharing planned: No
Related trials for Frailty Syndrome
Recruiting
Comparıson of the Effıcacy of Conventıonal Exercıse and Pılates ın Pre-fraıl and Fraıl Older Adults
Frailty Syndrome, Prefrail Elderly
Active, not recruiting
Prehabilitation in Pancreatic Surgery
Pancreatic Cancer, Periampullary Cancer
Not yet recruiting
Effect of Animation-Based Digital Education on Risk Knowledge and Frailty in Older Adults
Aging, Frail Elderly
Not yet recruitingObservational study
Prognostic Value of Functional-Nutritional Status in Older Adults With Acute Coronary Syndrome
Acute Coronary Syndromes (ACS)
RecruitingObservational study
Effects of Surgery on Oral Frailty and Dysphagia in Patients With Obstructive Sleep Apnea
OSA - Obstructive Sleep Apnea, Dysphagia
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Inmersive Virtual Reality and Conventional occupational therapy sessions in people with Frailty Syndrome and Older Adults, Balance, run by Universidad Rey Juan Carlos at 2 sites in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 16 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Cristina García-Bravo (914884877, cristina.bravo@urjc.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Functional Independence Measure (FIM) (time frame: Pre-intervention, post-intervention (up to 1 week) and follow-up (3-month)). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jul 2025.