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

Study Overview

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

• Study Type: Interventional
• Enrollment (Estimated): 90
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Elisa Pedroli, PsyD; Phone Number: 02 61911 2707; Email: e.pedroli@auxologico.it

Study Locations

• Italy
  • MI
    • Milan, MI, Italy, 20149
      • Recruiting
      • Istituto Auxologico Italiano IRCCS
      • Contact: Elisa Pedroli, PsyD; Phone Number: 02 61911 2707; Email: e.pedroli@auxologico.it

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Factorial Assignment
• Masking: Double

Number of Arms

6

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 360° media; All participants will be randomly assigned to 360° media or TAU condition	Device: 360° media; sessions with head mounted display in hospital and sessions with tablet at home
Active Comparator: Treatment As Usual (TAU); All participants will be randomly assigned to TAU or 360° media condition	Other: Treatment As Usual (TAU); sessions of TAU rehabilitation in hospital and sessions TAU rehabilitation at home
Other: In hospital sessions; all participants will perform session in hospital	Other: In hospital sessions; sessions will be carried out under the supervision of a therapist
Other: at home sessions; all participants will perform session at home	Other: at home sessions; sessions will be carried out without the supervision of a therapist
Other: Mild Cognitive Impairment; half of the patients will have MCI	Other: Mild Cognitive Impairment; half of this group will perform the protocol with 360° videos and the other half will perform the TAU
Other: Subjective Memory Complain; half of the patients will have SMC	Other: Subjective Memory Complain; half of this group will perform the protocol with 360° videos and the other half will perform the TAU

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Motor functions	Improvement in motor functioning assessed with specific test focused on balance, functional mobility, and walking speed	Immediately after the training experience

Collaborators and Investigators

• Sponsor: Istituto Auxologico Italiano

Study record dates

Study Major Dates

• Study Start (Actual): July 3, 2023
• Primary Completion (Estimated): April 10, 2026
• Study Completion (Estimated): April 10, 2026

Study Registration Dates

• First Submitted: October 6, 2023
• First Submitted That Met QC Criteria: March 1, 2024
• First Posted (Estimated): March 4, 2024

Study Record Updates

• Last Update Posted (Estimated): March 4, 2024
• Last Update Submitted That Met QC Criteria: March 1, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Neurocognitive Disorders; Cognition Disorders; Cognitive Dysfunction
• Other Study ID Numbers: 30M201

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No