Mild Cognitive Impairment
Conditions
Keywords
mild cognitive impairment, older adults, digital neurorehabilitation, Telerehabilitation, Therapeutic video games, Exergames, Gait and dual-task performance, Balance training
Brief 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). 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.
Interventions
BEHAVIORALDigital exergame-based neurorehabilitation program
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.
BEHAVIORALIndividual conventional physiotherapy
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).
Sponsors
European University of Madrid
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
70 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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.
Exclusion criteria
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Executive Functions (Trail Making Test, Part A and Part B; completion time in seconds) | 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) | 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) | 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) | 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) |
| Global Cognitive Function (Montreal Cognitive Assessment, MoCA; 0-30) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Short Physical Performance Battery (SPPB; 0-12) | Baseline (V0), Week 8 (V1), Week 16 (V2) | Change in SPPB total score (balance, gait speed, chair stands). Higher scores reflect better lower-extremity function. Will be analyzed as continuous and ordinal. |
| Mood (Geriatric Depression Scale, 15-item; total score) | Baseline (V0), Week 8 (V1), Week 16 (V2) | Change in depressive symptoms measured with GDS-15. Treated as a discrete quantitative variable; lower scores indicate fewer symptoms. |
| Functional Strength (Five Times Sit-to-Stand; seconds) | Baseline (V0), Week 8 (V1), Week 16 (V2) | Change in time to complete five chair rises without using the arms. Lower times indicate better functional lower-limb strength. |
| Instrumental Activities of Daily Living (Lawton-Brody IADL; total score) | Baseline (V0), Week 8 (V1), Week 16 (V2) | Change in independence for instrumental activities of daily living. Treated as a discrete quantitative variable; higher scores indicate greater autonomy. |
| Fear of Falling (Short Falls Efficacy Scale-International; total score) | Baseline (V0), Week 8 (V1), Week 16 (V2) | Change in concern about falling during daily activities. Lower scores reflect greater confidence. |
Countries
Spain
Contacts
CONTACTMarina Castel-Sánchez, PhD
Outcome results
None listed