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

NCT07423260 | Not Yet Recruiting

• 1 other identifier: NEUROREAVIRTDCL
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Mild Cognitive Impairment

Keywords

mild cognitive impairment; older adults; digital neurorehabilitation; Telerehabilitation; Therapeutic video games; Exergames; Gait and dual-task performance; Balance training

Outcome Measures

Primary Outcomes (5)

• 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.

  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.

  Baseline (V0), Week 8 (V1), Week 16 (V2)

• Gait Speed Under Single-Task Conditions (10-Meter Walk Test; meters/second)

  Change in usual gait speed measured with the 10-Meter Walk Test.

  Baseline (V0), Week 8 (V1), Week 16 (V2)

• 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.

  Baseline (V0), Week 8 (V1), Week 16 (V2)

• Health-Related Quality of Life (EQ-5D-5L Index Score)

  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)

  Baseline (V0), Week 8 (V1), Week 16 (V2)

Secondary Outcomes (5)

• 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)

Other Outcomes (11)

• Program Adherence (percent of planned sessions completed)

  During the 8-week intervention; summarized again at Week 16 (V2)

• Effective Practice Dose (minutes of active task execution per session and in total)

  During the 8-week intervention; summarized again at Week 16 (V2)

• Postural Accuracy

  During the 8-week intervention; summarized again at Week 16 (V2)

Study Arms (2)

Experimental - Exergame-Based Digital Neurorehabilitation

EXPERIMENTAL

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.

Behavioral: Digital exergame-based neurorehabilitation program

Active Comparator - Conventional Physiotherapy

ACTIVE COMPARATOR

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.

Behavioral: Individual conventional physiotherapy

Interventions

Digital exergame-based neurorehabilitation program BEHAVIORAL

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.

Experimental - Exergame-Based Digital Neurorehabilitation

Individual conventional physiotherapy BEHAVIORAL

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).

Active Comparator - Conventional Physiotherapy

Eligibility Criteria

• Age: 70 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• European University of Madrid: lead

Study Sites (1)

Universidad Europea de Madrid

Villaviciosa de Odón, Madrid, 28760, Spain

Location

MeSH Terms

Conditions

Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Central Study Contacts

Marina Castel-Sánchez, PhD

CONTACT

+34679448994; marina.castel@universidadeuropea.es

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: February 9, 2026
• First Posted: February 20, 2026
• Study Start: March 1, 2026
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): October 1, 2026
• Last Updated: February 20, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)