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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Digital exergame-based neurorehabilitation program | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | 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. | 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. | 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) | Baseline (V0), Week 8 (V1), Week 16 (V2) |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline (V0), Week 8 (V1), Week 16 (V2) |
| Instrumental Activities of Daily Living (Lawton-Brody IADL; total score) |
| Measure | Description | Time Frame |
|---|---|---|
| Program Adherence (percent of planned sessions completed) | Percentage of completed sessions out of 24 planned sessions (3/week × 8 weeks). Adequate adherence defined as ≥80%. | During the 8-week intervention; summarized again at Week 16 (V2) |
| Effective Practice Dose (minutes of active task execution per session and in total) |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Marina Castel-Sánchez, PhD | Contact | +34679448994 | marina.castel@universidadeuropea.es |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Universidad Europea de Madrid | Villaviciosa de Odón | Madrid | 28760 | Spain |
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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|
| Individual conventional physiotherapy | Behavioral | 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). |
|
Change in independence for instrumental activities of daily living. Treated as a discrete quantitative variable; higher scores indicate greater autonomy. |
| 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. | 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. | 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. | Baseline (V0), Week 8 (V1), Week 16 (V2) |
Clinician-timed minutes of active motor or cognitive task execution across sessions. |
| During the 8-week intervention; summarized again at Week 16 (V2) |
| Postural Accuracy | Number of correctly executed tasks per session | During the 8-week intervention; summarized again at Week 16 (V2) |
| Perceived Exertion (Modified Borg Scale; 0-10) | Session-level rating of perceived exertion; higher values indicate greater perceived effort. | End of each training session; summarized at Week 8 and Week 16 |
| Professional Workload (minutes per session) | Clinician time devoted to preparation, supervision, and documentation. | During the 8-week intervention; summarized at Week 16 (V2) |
| Usability (System Usability Scale; 0-100) | Usability measured with the System Usability Scale. | Week 8 (V1) and Week 16 (V2) |
| Direct cost per particiapnt (euros) | Direct costs per participant (professional time, materials, technical support) related to observed improvements in quality of life (EQ-5D-5L) | Baseline to Week 16 (V2) |
| Compensatory Movements | number of observed compensations per session | : During 8 week intervention; summarized again at Week 16 |
| Participant Satisfaction | 5 point Likert rating | Week 8 and Week 16 |
| Cost Effectiveness (Incremental Cost Effectiveness Ratio) | cost per unit of improvement | Baseline to Week 16 |
| Functional Autonomy (Lawton-Brody Scale) | total score (0-8) | Baseline to Week 16 |
| ID | Term |
|---|---|
| D060825 | Cognitive Dysfunction |
| ID | Term |
|---|---|
| D003072 | Cognition Disorders |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
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