Evaluation of a Digital Neurorehabilitation Program Using Exergames for Adults With Mild Cognitive Impairment

Condition(s) studied

Investigational drug(s) / intervention(s)

Digital 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.

Individual 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).

Study 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.

Eligibility

Primary outcome measure(s)

• 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.
• 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)

Trial sites (1)

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