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

Cognitive Decline Clinical Trial

— DUAL-Rehab  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06290167
• Other study ID #: 30M201
• Status: Recruiting
• Phase: N/A
• Start date: July 3, 2023
• Est. completion date: April 10, 2026

Study information

• Verified date: March 2024
• Source: Istituto Auxologico Italiano
• Contact: Elisa Pedroli, PsyD
• Phone: 02 61911 2707
• Email: e.pedroli[@]auxologico.it
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 90
• Est. completion date: April 10, 2026
• Est. primary completion date: April 10, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cognitive Decline
• Cognitive Dysfunction

Intervention

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

Other:
• 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

Locations

Country	Name	City	State
Italy	Istituto Auxologico Italiano IRCCS	Milan	MI

Sponsors (1)

Lead Sponsor	Collaborator
Istituto Auxologico Italiano

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cognitive functions	Improvement in cognitive functioning assessed with a complete neuropsychological battery focused on different domains such as executive function, memory, and attention.	Immediately after the training experience
Primary	Motor functions	Improvement in motor functioning assessed with specific test focused on balance, functional mobility, and walking speed	Immediately after the training experience