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

Not Applicable

Recruiting

• Conditions: Cognitive Decline
• Interventions: Device: 360° media; Other: In hospital sessions; Other: Subjective Memory Complain; Other: Mild Cognitive Impairment; Other: Treatment As Usual (TAU); Other: at home sessions

• Registration Number: NCT06290167
• Lead Sponsor: Istituto Auxologico Italiano

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-07-03
• Study First Submitted: 2023-10-06
• Status Verified: 2024-03
• Study First Submitted QC: 2024-03-01
• Last Update Submitted: 2024-03-01
• Study First Posted: 2024-03-04
• Last Update Posted: 2024-03-04
• Primary Completion: 2026-04-10
• Study Completion: 2026-04-10

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 90

Inclusion Criteria

Not provided

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
360° media	360° media	All participants will be randomly assigned to 360° media or TAU condition
In hospital sessions	In hospital sessions	all participants will perform session in hospital
Subjective Memory Complain	Subjective Memory Complain	half of the patients will have SMC
Mild Cognitive Impairment	Mild Cognitive Impairment	half of the patients will have MCI
Treatment As Usual (TAU)	Treatment As Usual (TAU)	All participants will be randomly assigned to TAU or 360° media condition
at home sessions	at home sessions	all participants will perform session at home

Primary Outcome Measures

Name	Time	Method
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 Locations

Locations (1)

Istituto Auxologico Italiano IRCCS; 🇮🇹 Milan, MI, Italy