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

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

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06290167
Acronym
DUAL-Rehab
Enrollment
90
Registered
2024-03-04
Start date
2023-07-03
Completion date
2026-04-10
Last updated
2025-08-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cognitive Decline

Brief 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.

Interventions

DEVICE360° media

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

OTHERTreatment As Usual (TAU)

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

OTHERIn hospital sessions

sessions will be carried out under the supervision of a therapist

OTHERat home sessions

sessions will be carried out without the supervision of a therapist

OTHERMild Cognitive Impairment

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

OTHERSubjective Memory Complain

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

Sponsors

Istituto Auxologico Italiano
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT
Masking
DOUBLE (Caregiver, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
65 Years to No maximum
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.

Design outcomes

Primary

MeasureTime frameDescription
Cognitive functionsImmediately after the training experienceImprovement in cognitive functioning assessed with a complete neuropsychological battery focused on different domains such as executive function, memory, and attention.
Motor functionsImmediately after the training experienceImprovement in motor functioning assessed with specific test focused on balance, functional mobility, and walking speed

Countries

Italy

Contacts

Primary ContactElisa Pedroli, PsyD
e.pedroli@auxologico.it02 61911 2707

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026