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

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

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 Overview

• Status: Not yet recruiting
• Conditions: Mild Cognitive Impairment
• Intervention / Treatment: Behavioral: Digital exergame-based neurorehabilitation program; Behavioral: Individual conventional physiotherapy

• Study Type: Interventional
• Enrollment (Estimated): 38
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Marina Castel-Sánchez, PhD; Phone Number: +34679448994; Email: marina.castel@universidadeuropea.es

Study Locations

• Spain
  • Madrid
    • Villaviciosa de Odón, Madrid, Spain, 28760
      • Universidad Europea de Madrid
      • Contact: Marina Castel-Sánchez, PhD; Phone Number: 0034+679448994; Email: marina_spa@hotmail.it

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Behavioral: 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.
Active Comparator: 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.	Behavioral: 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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Short Physical Performance Battery (SPPB; 0-12)	Change in SPPB total score (balance, gait speed, chair stands). Higher scores reflect better lower-extremity function. Will be analyzed as continuous and ordinal.	Baseline (V0), Week 8 (V1), Week 16 (V2)
Instrumental Activities of Daily Living (Lawton-Brody IADL; total score)	Change in independence for instrumental activities of daily living. Treated as a discrete quantitative variable; higher scores indicate greater autonomy.	Baseline (V0), Week 8 (V1), Week 16 (V2)
Fear of Falling (Short Falls Efficacy Scale-International; total score)	Change in concern about falling during daily activities. Lower scores reflect greater confidence.	Baseline (V0), Week 8 (V1), Week 16 (V2)
Mood (Geriatric Depression Scale, 15-item; total score)	Change in depressive symptoms measured with GDS-15. Treated as a discrete quantitative variable; lower scores indicate fewer symptoms.	Baseline (V0), Week 8 (V1), Week 16 (V2)
Functional Strength (Five Times Sit-to-Stand; seconds)	Change in time to complete five chair rises without using the arms. Lower times indicate better functional lower-limb strength.	Baseline (V0), Week 8 (V1), Week 16 (V2)

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Program Adherence (percent of planned sessions completed)	Percentage of completed sessions out of 24 planned sessions (3/week × 8 weeks). Adequate adherence defined as ≥80%.	During the 8-week intervention; summarized again at Week 16 (V2)
Effective Practice Dose (minutes of active task execution per session and in total)	Clinician-timed minutes of active motor or cognitive task execution across sessions.	During the 8-week intervention; summarized again at Week 16 (V2)
Postural Accuracy	Number of correctly executed tasks per session	During the 8-week intervention; summarized again at Week 16 (V2)
Perceived Exertion (Modified Borg Scale; 0-10)	Session-level rating of perceived exertion; higher values indicate greater perceived effort.	End of each training session; summarized at Week 8 and Week 16
Professional Workload (minutes per session)	Clinician time devoted to preparation, supervision, and documentation.	During the 8-week intervention; summarized at Week 16 (V2)
Usability (System Usability Scale; 0-100)	Usability measured with the System Usability Scale.	Week 8 (V1) and Week 16 (V2)
Direct cost per particiapnt (euros)	Direct costs per participant (professional time, materials, technical support) related to observed improvements in quality of life (EQ-5D-5L)	Baseline to Week 16 (V2)
Compensatory Movements	number of observed compensations per session	: During 8 week intervention; summarized again at Week 16
Participant Satisfaction	5 point Likert rating	Week 8 and Week 16
Cost Effectiveness (Incremental Cost Effectiveness Ratio)	cost per unit of improvement	Baseline to Week 16
Functional Autonomy (Lawton-Brody Scale)	total score (0-8)	Baseline to Week 16

Collaborators and Investigators

• Sponsor: European University of Madrid

Study record dates

Study Major Dates

• Study Start (Estimated): March 1, 2026
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): October 1, 2026

Study Registration Dates

• First Submitted: February 9, 2026
• First Submitted That Met QC Criteria: February 17, 2026
• First Posted (Actual): February 20, 2026

Study Record Updates

• Last Update Posted (Actual): February 20, 2026
• Last Update Submitted That Met QC Criteria: February 17, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: older adults; Telerehabilitation; mild cognitive impairment; Balance training; Exergames; digital neurorehabilitation; Therapeutic video games; Gait and dual-task performance
• Additional Relevant MeSH Terms: Mental Disorders; Neurocognitive Disorders; Cognition Disorders; Cognitive Dysfunction
• Other Study ID Numbers: NEUROREAVIRTDCL

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Individual participant data (IPD) will not be shared due to privacy considerations and institutional regulations regarding access to sensitive health information.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No