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

Официальное название

Digital Exergame Neurorehabilitation to Enhance Quality of Life and Functional Autonomy in Institutionalized Older Adults With Mild Cognitive Impairment: Randomized Controlled Trial

Обзор

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.

Вмешательства

• Поведенческое 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 exami
• Поведенческое 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).

Первичные конечные точки

• Global Cognitive Function (Montreal Cognitive Assessment, MoCA; 0-30) [Срок оценки: 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) [Срок оценки: Baseline (V0), Week 8 (V1), Week 16 (V2)]
• Gait Speed Under Single-Task Conditions (10-Meter Walk Test; meters/second) [Срок оценки: Baseline (V0), Week 8 (V1), Week 16 (V2)]
• Dual-Task Cost in Gait Speed (percentage) [Срок оценки: Baseline (V0), Week 8 (V1), Week 16 (V2)]
• Health-Related Quality of Life (EQ-5D-5L Index Score) [Срок оценки: Baseline (V0), Week 8 (V1), Week 16 (V2)]

Вторичные конечные точки (5)

• Short Physical Performance Battery (SPPB; 0-12) [Срок оценки: Baseline (V0), Week 8 (V1), Week 16 (V2)]
• Instrumental Activities of Daily Living (Lawton-Brody IADL; total score) [Срок оценки: Baseline (V0), Week 8 (V1), Week 16 (V2)]
• Fear of Falling (Short Falls Efficacy Scale-International; total score) [Срок оценки: Baseline (V0), Week 8 (V1), Week 16 (V2)]
• Mood (Geriatric Depression Scale, 15-item; total score) [Срок оценки: Baseline (V0), Week 8 (V1), Week 16 (V2)]
• Functional Strength (Five Times Sit-to-Stand; seconds) [Срок оценки: Baseline (V0), Week 8 (V1), Week 16 (V2)]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

Испания · 1 центр

• Universidad Europea de Madrid — Villaviciosa de Odón

Идентификаторы

NCT: NCT07423260 · NEUROREAVIRTDCL

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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