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

N/ANot Yet RecruitingNCT07423260

European University of Madrid38 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Mild Cognitive Impairment

Interventions

Digital exergame-based neurorehabilitation programBEHAVIORAL

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 physiotherapyBEHAVIORAL

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).

Outcomes

Primary Outcomes

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.

Time frame: 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)

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.