Mild Cognitive ImpairmentNCT07423260
Evaluation of a Digital Neurorehabilitation Program Using Exergames for Adults With Mild Cognitive Impairment
A study testing Digital exergame-based neurorehabilitation program and Individual conventional physiotherapy in people with Mild Cognitive Impairment, run by European University of Madrid at 1 site in Spain.
Trial summary
The goal of this clinical trial is to learn whether a semi-autonomous digital telerehabilitation program using therapeutic video games ("exergames") can help improve quality of life and functional independence in older adults living in long-term care centers who have mild cognitive impairment (MCI). Read more about this study
- Who is it for?
- Ages 70 years and older
- Conditions the study is for
- Mild Cognitive Impairment
- What is being tested?
- Digital exergame-based neurorehabilitation program and Individual conventional physiotherapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 1 siteSpain
- Study dates
- Mar 2026to Oct 2026
- 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 70 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Age 70 years or older.
- Diagnosis of mild cognitive impairment, defined by Montreal Cognitive Assessment (MoCA) score between 18 and 25.
- Ability to maintain standing and/or ambulate with or without assistive devices.
- Institutional residence for at least 3 months.
- Informed consent provided by participant or legal representative.
Who cannot join
- Acute illness, musculoskeletal condition, or pain that limits safe participation in training.
- Uncompensated sensory deficits (vision or hearing) that interfere with task performance.
- Disruptive behavior or neuropsychiatric symptoms that impede participation.
- Active epilepsy or medical contraindications for physical exercise.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Spain1 site
Universidad Europea de Madrid
Villaviciosa de Odón, Madrid, 28760
Marina Castel-Sánchez, PhD, 0034+679448994, marina_spa@hotmail.it
About this study
Official title: Digital Exergame Neurorehabilitation to Enhance Quality of Life and Functional Autonomy in Institutionalized Older Adults With Mild Cognitive Impairment: Randomized Controlled Trial
The goal of this clinical trial is to learn whether a semi-autonomous digital telerehabilitation program using therapeutic video games ("exergames") can help improve quality of life and functional independence in older adults living in long-term care centers who have mild cognitive impairment (MCI).
The main questions we want to answer are:
Read more
Does this exergame-based program help participants move better, walk more safely, and perform daily activities with more independence? Does it improve confidence while moving and lower the fear of falling? Is this program cost-effective compared with a standard one-to-one physiotherapy program?
Researchers will compare two groups:
Intervention group: participants will use a CE-marked digital rehabilitation platform that provides lower-limb and balance training through interactive exergames.
Control group: participants will receive an individual physiotherapy program of similar duration and intensity.
Participants will:
Take part in a 6-week training program (using exergames or standard physiotherapy, depending on their group).
Complete tests that measure mobility, balance, walking while doing a cognitive task (called "dual task"), confidence in avoiding falls, and daily functioning.
Answer short questionnaires about well-being and quality of life.
This pilot study will help determine whether the exergame-based program is safe, useful, and feasible for older adults with MCI living in long-term care settings.
- Conditions
- Mild Cognitive Impairment
- Being tested
- Digital exergame-based neurorehabilitation program, Individual conventional physiotherapy
- Keywords
- mild cognitive impairment, older adults, digital neurorehabilitation, Telerehabilitation, Therapeutic video games, Exergames, Gait and dual-task performance, Balance training
- Medical subject headings
- Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Digital exergame-based neurorehabilitation programBehavioural
Participants will perform interactive exergame-based exercises targeting lower-limb strength, balance, postural control, and cognitive-motor interaction. Exercises progressively increase in difficulty and incorporate tasks that require simultaneous physical movement and cognitive processing (dual-task training).
Intervention Dose:
Three sessions per week for eight weeks. Each session lasts 30-40 minutes.
Follow-Up:
Outcome assessments at baseline (V0), week 8 (V8), and week 16 (V16) to examine maintenance of benefits.
Individual conventional physiotherapyBehavioural
Sessions include traditional balance exercises, strength training for the lower limbs, gait practice, and functional mobility activities conducted by a physiotherapist.
Intervention Dose:
Three sessions per week for eight weeks. Session duration is equivalent to the experimental group.
Follow-Up:
Outcome assessments at baseline (V0), week 8 (V8), and week 16 (V16).
| Study group | Role | What they receive |
|---|---|---|
| Experimental - Exergame-Based Digital Neurorehabilitation | Experimental | Participants will complete a structured digital neurorehabilitation program using a CE-marked telerehabilitation platform that delivers lower-limb and balance training through therapeutic video games (exergames). The program integrates motor and cognitive tasks to promote functional mobility, balance, and dual-task performance. Training is semi-autonomous, with remote monitoring and real-time feedback. Receives: Behavioral: Digital exergame-based neurorehabilitation program |
| Active Comparator - Conventional Physiotherapy | Active comparator | Participants will receive a standard individual physiotherapy program focused on lower-limb strengthening, balance training, and gait exercises. The duration and weekly frequency will be equivalent to the intervention group. Receives: Behavioral: Individual conventional physiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Global Cognitive Function (Montreal Cognitive Assessment, MoCA; 0-30)
Change in MoCA total score, which assesses memory, attention, language, orientation, executive functions, and visuospatial abilities. Scores range from 0 to 30; higher scores indicate better cognitive performance.
Measured: Baseline (V0), Week 8 (V1, end of treatment), Week 16 (V2, follow-up)
Executive Functions (Trail Making Test, Part A and Part B; completion time in seconds)
Change in completion time for TMT-A (attention/processing speed) and TMT-B (set-shifting/flexibility). Lower times indicate better performance. Analyses will consider Part A and Part B separately; the B-A difference may be explored as an index of executive control.
Measured: Baseline (V0), Week 8 (V1), Week 16 (V2)
Gait Speed Under Single-Task Conditions (10-Meter Walk Test; meters/second)
Change in usual gait speed measured with the 10-Meter Walk Test.
Measured: Baseline (V0), Week 8 (V1), Week 16 (V2)
Dual-Task Cost in Gait Speed (percentage)
Change in dual-task cost (DTC) in gait speed during a concurrent cognitive task (for example, serial subtraction or animal naming) versus single-task walking, calculated as:
DTC(%) = [(single-task speed - dual-task speed) / single-task speed] × 100. Lower percentages indicate less cognitive-motor interference and better dual-task performance.
Measured: Baseline (V0), Week 8 (V1), Week 16 (V2)
Health-Related Quality of Life (EQ-5D-5L Index Score)
Change in the EuroQol EQ-5D-5L index utility score; higher values indicate better health-related quality of life. The visual analogue scale (VAS, 0-100) will be analyzed separately (see Secondary Outcomes)
Measured: Baseline (V0), Week 8 (V1), Week 16 (V2)
Secondary outcomes (5)
Short Physical Performance Battery (SPPB; 0-12)
Change in SPPB total score (balance, gait speed, chair stands). Higher scores reflect better lower-extremity function. Will be analyzed as continuous and ordinal.
Measured: Baseline (V0), Week 8 (V1), Week 16 (V2)
Instrumental Activities of Daily Living (Lawton-Brody IADL; total score)
Change in independence for instrumental activities of daily living. Treated as a discrete quantitative variable; higher scores indicate greater autonomy.
Measured: Baseline (V0), Week 8 (V1), Week 16 (V2)
Fear of Falling (Short Falls Efficacy Scale-International; total score)
Change in concern about falling during daily activities. Lower scores reflect greater confidence.
Measured: Baseline (V0), Week 8 (V1), Week 16 (V2)
Mood (Geriatric Depression Scale, 15-item; total score)
Change in depressive symptoms measured with GDS-15. Treated as a discrete quantitative variable; lower scores indicate fewer symptoms.
Measured: Baseline (V0), Week 8 (V1), Week 16 (V2)
Functional Strength (Five Times Sit-to-Stand; seconds)
Change in time to complete five chair rises without using the arms. Lower times indicate better functional lower-limb strength.
Measured: Baseline (V0), Week 8 (V1), Week 16 (V2)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2026
- Study startMar 2026 (estimated)
- Primary completionJul 2026 (estimated)
- Study completionOct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mild Cognitive ImpairmentStudies 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
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 38 participants (estimated)
Sponsor and investigators
- Lead sponsor
- European University of Madrid
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marina Castel Sánchez, European University of Madrid
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07423260
- Sponsor's protocol ID
- NEUROREAVIRTDCL
- Status last verified
- Feb 2026
- First submitted
- 9 Feb 2026
- Last updated
- 20 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data (IPD) will not be shared due to privacy considerations and institutional regulations regarding access to sensitive health information.
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Digital Exergame Neurorehabilitation to Enhance Quality of Life and Functional Autonomy in Institutionalized Older Adults With Mild Cognitive Impairment: Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07423260
- Acronym / sponsor ID
- NEUROREAVIRTDCL
- Conditions
- Mild Cognitive Impairment
- Keywords
- mild cognitive impairment, older adults, digital neurorehabilitation, Telerehabilitation, Therapeutic video games, Exergames, Gait and dual-task performance, Balance training
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 38 participants (estimated)
- Lead sponsor
- European University of MadridUniversity, hospital or other
- Study start
- Mar 2026 (estimated)
- Primary completion
- Jul 2026 (estimated)
- Study completion
- Oct 2026 (estimated)
- First posted
- 20 Feb 2026 (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.
The goal of this clinical trial is to learn whether a semi-autonomous digital telerehabilitation program using therapeutic video games ("exergames") can help improve quality of life and functional independence in older adults living in long-term care centers who have mild cognitive impairment (MCI).
The main questions we want to answer are:
Does this exergame-based program help participants move better, walk more safely, and perform daily activities with more independence? Does it improve confidence while moving and lower the fear of falling? Is this program cost-effective compared with a standard one-to-one physiotherapy program?
Researchers will compare two groups:
Intervention group: participants will use a CE-marked digital rehabilitation platform that provides lower-limb and balance training through interactive exergames.
Control group: participants will receive an individual physiotherapy program of similar duration and intensity.
Participants will:
Take part in a 6-week training program (using exergames or standard physiotherapy, depending on their group).
Complete tests that measure mobility, balance, walking while doing a cognitive task (called "dual task"), confidence in avoiding falls, and daily functioning.
Answer short questionnaires about well-being and quality of life.
This pilot study will help determine whether the exergame-based program is safe, useful, and feasible for older adults with MCI living in long-term care settings.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental - Exergame-Based Digital Neurorehabilitation | Experimental | Behavioral: Digital exergame-based neurorehabilitation programParticipants will complete a structured digital neurorehabilitation program using a CE-marked telerehabilitation platform that delivers lower-limb and balance training through therapeutic video games (exergames). The program integrates motor and cognitive tasks to promote functional mobility, balance, and dual-task performance. Training is semi-autonomous, with remote monitoring and real-time feedback. |
| Active Comparator - Conventional Physiotherapy | Active comparator | Behavioral: Individual conventional physiotherapyParticipants will receive a standard individual physiotherapy program focused on lower-limb strengthening, balance training, and gait exercises. The duration and weekly frequency will be equivalent to the intervention group. |
Who may qualify
- Ages
- 70 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (5 listed)
- Age 70 years or older.
- Diagnosis of mild cognitive impairment, defined by Montreal Cognitive Assessment (MoCA) score between 18 and 25.
- Ability to maintain standing and/or ambulate with or without assistive devices.
- Institutional residence for at least 3 months.
- Informed consent provided by participant or legal representative.
Key exclusion criteria (4 listed)
- Acute illness, musculoskeletal condition, or pain that limits safe participation in training.
- Uncompensated sensory deficits (vision or hearing) that interfere with task performance.
- Disruptive behavior or neuropsychiatric symptoms that impede participation.
- Active epilepsy or medical contraindications for physical exercise.
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 |
|---|---|---|
| Digital exergame-based neurorehabilitation programParticipants will perform interactive exergame-based exercises targeting lower-limb strength, balance, postural control, and cognitive-motor interaction. Exercises progressively increase in difficulty and incorporate tasks that require simultaneous physical movement and cognitive processing (dual-task training). Intervention Dose: Three sessions per week for eight weeks. Each session lasts 30-40 minutes. Follow-Up: Outcome assessments at baseline (V0), week 8 (V8), and week 16 (V16) to examine maintenance of benefits. | Behavioural | Experimental - Exergame-Based Digital Neurorehabilitation |
| Individual conventional physiotherapySessions include traditional balance exercises, strength training for the lower limbs, gait practice, and functional mobility activities conducted by a physiotherapist. Intervention Dose: Three sessions per week for eight weeks. Session duration is equivalent to the experimental group. Follow-Up: Outcome assessments at baseline (V0), week 8 (V8), and week 16 (V16). | Behavioural | Active Comparator - Conventional Physiotherapy |
Primary outcome
Global Cognitive Function (Montreal Cognitive Assessment, MoCA; 0-30)
Time frame: Baseline (V0), Week 8 (V1, end of treatment), Week 16 (V2, follow-up)
Change in MoCA total score, which assesses memory, attention, language, orientation, executive functions, and visuospatial abilities. Scores range from 0 to 30; higher scores indicate better cognitive performance.
Executive Functions (Trail Making Test, Part A and Part B; completion time in seconds)
Time frame: Baseline (V0), Week 8 (V1), Week 16 (V2)
Change in completion time for TMT-A (attention/processing speed) and TMT-B (set-shifting/flexibility). Lower times indicate better performance. Analyses will consider Part A and Part B separately; the B-A difference may be explored as an index of executive control.
Gait Speed Under Single-Task Conditions (10-Meter Walk Test; meters/second)
Time frame: Baseline (V0), Week 8 (V1), Week 16 (V2)
Change in usual gait speed measured with the 10-Meter Walk Test.
Dual-Task Cost in Gait Speed (percentage)
Time frame: Baseline (V0), Week 8 (V1), Week 16 (V2)
Change in dual-task cost (DTC) in gait speed during a concurrent cognitive task (for example, serial subtraction or animal naming) versus single-task walking, calculated as: DTC(%) = [(single-task speed - dual-task speed) / single-task speed] × 100. Lower percentages indicate less cognitive-motor interference and better dual-task performance.
Health-Related Quality of Life (EQ-5D-5L Index Score)
Time frame: Baseline (V0), Week 8 (V1), Week 16 (V2)
Change in the EuroQol EQ-5D-5L index utility score; higher values indicate better health-related quality of life. The visual analogue scale (VAS, 0-100) will be analyzed separately (see Secondary Outcomes)
5 secondary outcomes
Short Physical Performance Battery (SPPB; 0-12)
Time frame: Baseline (V0), Week 8 (V1), Week 16 (V2)
Instrumental Activities of Daily Living (Lawton-Brody IADL; total score)
Time frame: Baseline (V0), Week 8 (V1), Week 16 (V2)
Fear of Falling (Short Falls Efficacy Scale-International; total score)
Time frame: Baseline (V0), Week 8 (V1), Week 16 (V2)
Mood (Geriatric Depression Scale, 15-item; total score)
Time frame: Baseline (V0), Week 8 (V1), Week 16 (V2)
Functional Strength (Five Times Sit-to-Stand; seconds)
Time frame: Baseline (V0), Week 8 (V1), Week 16 (V2)
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 20 Feb 2026.
- Individual participant dataSharing planned: No. Individual participant data (IPD) will not be shared due to privacy considerations and institutional regulations regarding access to sensitive health information.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Digital exergame-based neurorehabilitation program and Individual conventional physiotherapy in people with Mild Cognitive Impairment, run by European University of Madrid at 1 site 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 5 inclusion and 4 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 20 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 Marina Castel-Sánchez, PhD (+34679448994, marina.castel@universidadeuropea.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Global Cognitive Function (Montreal Cognitive Assessment, MoCA; 0-30) (time frame: Baseline (V0), Week 8 (V1, end of treatment), Week 16 (V2, follow-up)). The study lists 5 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 20 Feb 2026.