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Recruiting Not applicable

A New 360° Dual-task Based Protocol for the Pre-clinical In-hospital and At-home Rehabilitation of Elderly: DUAL-Rehab

NCT06290167 · tracked via the Priya Life Science Italy tracker
Phase
Not applicable
Started
2023-07-03
Last updated
2025-08-04

Condition(s) studied

Cognitive Decline

Investigational drug(s) / intervention(s)

360° mediaTreatment As Usual (TAU)In hospital sessionsat home sessionsMild Cognitive ImpairmentSubjective Memory Complain

360° media: sessions with head mounted display in hospital and sessions with tablet at home

Treatment As Usual (TAU): sessions of TAU rehabilitation in hospital and sessions TAU rehabilitation at home

In hospital sessions: sessions will be carried out under the supervision of a therapist

at home sessions: sessions will be carried out without the supervision of a therapist

Mild Cognitive Impairment: half of this group will perform the protocol with 360° videos and the other half will perform the TAU

Subjective Memory Complain: half of this group will perform the protocol with 360° videos and the other half will perform the TAU

Study summary

The main objective of this project is two-fold

1. to develop a Dual-Task training exploiting the potentiality of the 360° technology in terms of interactivity and ecological validity
2. to investigate its efficacy in improving the cognitive functioning in a randomized clinical trial for 2 different populations: subjects with subjective memory complaints and mild cognitive impairment.

Specifically, participants will follow an integrated training including 2 phases: 1)in-hospital rehabilitation, where subjects will be provided sessions of the training in immersive modality; 2)at-home rehabilitation, where older adults will be asked to perform at home the non-immersive version of the training using a tablet.

Expected outcome is an improvement in cognitive functioning (assessed with a complete neuropsychological battery) after the training, thus advancing literature about non-pharmacological interventions in the preclinical stages of dementia along with innovative technical instruments.

Eligibility

Sex
ALL
Min age
65 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria (group of SMC): * \> 65 years old * self-reported memory complaints * score on Mini-Mental State Examination greater than or equal to 27/30 (normal range) Exclusion Criteria: * no evidence of objective impairments on the neuropsychological testing, scores on the Clinical Dementia Rating \< 0.5 Inclusion Criteria (group of MCI): * \> 65 years old * a self-reported (or reported by a caregiver) cognitive decline * an objective impairment on the neuropsychological testing * scores on the Clinical Dementia Rating \< 0.5. Exclusion Criteria: * no dementia

Primary outcome measure(s)

  • Cognitive functions — Immediately after the training experience
    Improvement in cognitive functioning assessed with a complete neuropsychological battery focused on different domains such as executive function, memory, and attention.
  • Motor functions — Immediately after the training experience
    Improvement in motor functioning assessed with specific test focused on balance, functional mobility, and walking speed

Trial sites (1)

FacilityCityRegionStatus
Istituto Auxologico Italiano IRCCS Milan MI Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06290167 on ClinicalTrials.gov ↗ ← All trials in Italy