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.
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.
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.
Parallel
Digital exergame-based neurorehabilitation program
BehavioralParticipants 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 physiotherapy
BehavioralSessions 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).
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.
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.
Gait Speed Under Single-Task Conditions (10-Meter Walk Test; meters/second)
Change in usual gait speed measured with the 10-Meter Walk Test.
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.
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.
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.
Fear of Falling (Short Falls Efficacy Scale-International; total score)
Change in concern about falling during daily activities. Lower scores reflect greater confidence.
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.
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%.
Effective Practice Dose (minutes of active task execution per session and in total)
Clinician-timed minutes of active motor or cognitive task execution across sessions.
Postural Accuracy
Number of correctly executed tasks per session
Perceived Exertion (Modified Borg Scale; 0-10)
Session-level rating of perceived exertion; higher values indicate greater perceived effort.
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