Digital Exergame Neurorehabilitation to Enhance Quality of Life and Functional Autonomy in Institutionalized Older Adults With Mild Cognitive Impairment: Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 38
- 试验地点
- 1
- 主要终点
- Global Cognitive Function (Montreal Cognitive Assessment, MoCA; 0-30)
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 70 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 70 years or older.
- •Diagnosis of mild cognitive impairment, defined by Montreal Cognitive Assessment (MoCA) score between 18 and
- •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.
排除标准
- •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.
研究组 & 干预措施
Experimental - Exergame-Based Digital Neurorehabilitation
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.
干预措施: Digital exergame-based neurorehabilitation program (Behavioral)
Active Comparator - Conventional Physiotherapy
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.
干预措施: Individual conventional physiotherapy (Behavioral)
结局指标
主要结局
Global Cognitive Function (Montreal Cognitive Assessment, MoCA; 0-30)
时间窗: 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)
时间窗: 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)
时间窗: 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)
时间窗: 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)
时间窗: 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)
次要结局
- Short Physical Performance Battery (SPPB; 0-12)(Baseline (V0), Week 8 (V1), Week 16 (V2))
- Instrumental Activities of Daily Living (Lawton-Brody IADL; total score)(Baseline (V0), Week 8 (V1), Week 16 (V2))
- Fear of Falling (Short Falls Efficacy Scale-International; total score)(Baseline (V0), Week 8 (V1), Week 16 (V2))
- Mood (Geriatric Depression Scale, 15-item; total score)(Baseline (V0), Week 8 (V1), Week 16 (V2))
- Functional Strength (Five Times Sit-to-Stand; seconds)(Baseline (V0), Week 8 (V1), Week 16 (V2))
研究者
Marina Castel Sánchez
Associate Professor
European University of Madrid