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NCT Number: NCT06290167

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

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.

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Key information

Conditions

Cognitive Decline Cognition Disorders Cognitive Dysfunction Mental Disorders Neurocognitive Disorders

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Istituto Auxologico Italiano IRCCS

Milan, MI, 20149, Italy

Location status: Recruiting

Location contact

Elisa Pedroli, PsyD

CONTACT

[email protected]

02 61911 2707

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

360° media

Device

sessions with head mounted display in hospital and sessions with tablet at home

Treatment as usual (TAU)

Other

sessions of TAU rehabilitation in hospital and sessions TAU rehabilitation at home

In hospital sessions

Other

sessions will be carried out under the supervision of a therapist

at home sessions

Other

sessions will be carried out without the supervision of a therapist

Mild Cognitive Impairment

Other

half of this group will perform the protocol with 360° videos and the other half will perform the TAU

Subjective Memory Complain

Other

half of this group will perform the protocol with 360° videos and the other half will perform the TAU

Primary outcomes

  1. Cognitive functions

    Time frame: 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.

  2. Motor functions

    Time frame: Immediately after the training experience

    Improvement in motor functioning assessed with specific test focused on balance, functional mobility, and walking speed

Study contacts

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

Elisa Pedroli, PsyD

CONTACT

[email protected]

02 61911 2707

Sponsors and collaborators

Lead sponsor

Istituto Auxologico Italiano

Other

Registry information

Acronym: DUAL-Rehab

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Mar 4, 2024
Registry last updated
Aug 4, 2025

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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