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NCT Number: NCT07423260

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

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.

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Key information

Conditions

Mild Cognitive Impairment Cognition Disorders Cognitive Dysfunction Mental Disorders Neurocognitive Disorders

Age range

70 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Universidad Europea de Madrid

Villaviciosa de Odón, Madrid, 28760, Spain

Location contact

Marina Castel-Sánchez, PhD

CONTACT

[email protected]

0034+679448994

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

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).

Primary outcomes

  1. Global Cognitive Function (Montreal Cognitive Assessment, MoCA; 0-30)

    Time frame: 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.

  2. Executive Functions (Trail Making Test, Part A and Part B; completion time in seconds)

    Time frame: 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.

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

    Time frame: Baseline (V0), Week 8 (V1), Week 16 (V2)

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

  4. Dual-Task Cost in Gait Speed (percentage)

    Time frame: 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.

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

    Time frame: 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)

Secondary outcomes

  1. Short Physical Performance Battery (SPPB; 0-12)

    Time frame: Baseline (V0), Week 8 (V1), Week 16 (V2)

    Change in SPPB total score (balance, gait speed, chair stands). Higher scores reflect better lower-extremity function. Will be analyzed as continuous and ordinal.

  2. Instrumental Activities of Daily Living (Lawton-Brody IADL; total score)

    Time frame: Baseline (V0), Week 8 (V1), Week 16 (V2)

    Change in independence for instrumental activities of daily living. Treated as a discrete quantitative variable; higher scores indicate greater autonomy.

  3. Fear of Falling (Short Falls Efficacy Scale-International; total score)

    Time frame: Baseline (V0), Week 8 (V1), Week 16 (V2)

    Change in concern about falling during daily activities. Lower scores reflect greater confidence.

  4. Mood (Geriatric Depression Scale, 15-item; total score)

    Time frame: Baseline (V0), Week 8 (V1), Week 16 (V2)

    Change in depressive symptoms measured with GDS-15. Treated as a discrete quantitative variable; lower scores indicate fewer symptoms.

  5. Functional Strength (Five Times Sit-to-Stand; seconds)

    Time frame: Baseline (V0), Week 8 (V1), Week 16 (V2)

    Change in time to complete five chair rises without using the arms. Lower times indicate better functional lower-limb strength.

Other outcomes

  1. Program Adherence (percent of planned sessions completed)

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

    Percentage of completed sessions out of 24 planned sessions (3/week × 8 weeks). Adequate adherence defined as ≥80%.

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

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

    Clinician-timed minutes of active motor or cognitive task execution across sessions.

  3. Postural Accuracy

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

    Number of correctly executed tasks per session

  4. Perceived Exertion (Modified Borg Scale; 0-10)

    Time frame: End of each training session; summarized at Week 8 and Week 16

    Session-level rating of perceived exertion; higher values indicate greater perceived effort.

  5. Professional Workload (minutes per session)

    Time frame: During the 8-week intervention; summarized at Week 16 (V2)

    Clinician time devoted to preparation, supervision, and documentation.

  6. Usability (System Usability Scale; 0-100)

    Time frame: Week 8 (V1) and Week 16 (V2)

    Usability measured with the System Usability Scale.

  7. Direct cost per particiapnt (euros)

    Time frame: Baseline to Week 16 (V2)

    Direct costs per participant (professional time, materials, technical support) related to observed improvements in quality of life (EQ-5D-5L)

  8. Compensatory Movements

    Time frame: : During 8 week intervention; summarized again at Week 16

    number of observed compensations per session

  9. Participant Satisfaction

    Time frame: Week 8 and Week 16

    5 point Likert rating

  10. Cost Effectiveness (Incremental Cost Effectiveness Ratio)

    Time frame: Baseline to Week 16

    cost per unit of improvement

  11. Functional Autonomy (Lawton-Brody Scale)

    Time frame: Baseline to Week 16

    total score (0-8)

Study contacts

Contact information is provided by the study sponsor or research team.

Marina Castel-Sánchez, PhD

CONTACT

[email protected]

+34679448994

Sponsors and collaborators

Lead sponsor

European University of Madrid

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Feb 20, 2026
Registry last updated
Feb 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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