Menu
Not yet recruiting NCT07423260

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

No phase Interventional Mild Cognitive Impairment

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Digital exergame-based neurorehabilitation program, Individual conventional physiotherapy.
Who it may be relevant to
Registry conditions: Mild Cognitive Impairment. Basic parameters: from 70 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Spain
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

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.

Interventions

  • 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 exami
  • 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).

Primary outcome measures

  • Global Cognitive Function (Montreal Cognitive Assessment, MoCA; 0-30) [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) [Time frame: Baseline (V0), Week 8 (V1), Week 16 (V2)]
  • Gait Speed Under Single-Task Conditions (10-Meter Walk Test; meters/second) [Time frame: Baseline (V0), Week 8 (V1), Week 16 (V2)]
  • Dual-Task Cost in Gait Speed (percentage) [Time frame: Baseline (V0), Week 8 (V1), Week 16 (V2)]
  • Health-Related Quality of Life (EQ-5D-5L Index Score) [Time frame: Baseline (V0), Week 8 (V1), Week 16 (V2)]
Secondary outcome measures (5)
  • Short Physical Performance Battery (SPPB; 0-12) [Time frame: Baseline (V0), Week 8 (V1), Week 16 (V2)]
  • Instrumental Activities of Daily Living (Lawton-Brody IADL; total score) [Time frame: Baseline (V0), Week 8 (V1), Week 16 (V2)]
  • Fear of Falling (Short Falls Efficacy Scale-International; total score) [Time frame: Baseline (V0), Week 8 (V1), Week 16 (V2)]
  • Mood (Geriatric Depression Scale, 15-item; total score) [Time frame: Baseline (V0), Week 8 (V1), Week 16 (V2)]
  • Functional Strength (Five Times Sit-to-Stand; seconds) [Time frame: Baseline (V0), Week 8 (V1), Week 16 (V2)]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

Spain · 1 center
  • Universidad Europea de Madrid — Villaviciosa de Odón

Identifiers

NCT: NCT07423260 · NEUROREAVIRTDCL

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗