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

Istituto Auxologico Italiano

Status: Enrolling

Conditions: Cognitive Decline

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

Study type: Interventional

Funder types: Other

Identifiers

NCT06290167

30M201

Details and patient eligibility

About

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.

Enrollment: 90 estimated patients

Sex: All

Ages: 65+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: Double Blind

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90 participants in 6 patient groups

360° media

Experimental group

Description:

All participants will be randomly assigned to 360° media or TAU condition

Treatment:

Device: 360° media

Treatment As Usual (TAU)

Active Comparator group

Description:

All participants will be randomly assigned to TAU or 360° media condition

Treatment:

Other: Treatment As Usual (TAU)

In hospital sessions

Other group

Description:

all participants will perform session in hospital

Treatment:

Other: In hospital sessions

at home sessions

Other group

Description:

all participants will perform session at home

Treatment:

Other: at home sessions

Mild Cognitive Impairment

Other group

Description:

half of the patients will have MCI

Treatment:

Other: Mild Cognitive Impairment

Subjective Memory Complain

Other group

Description:

half of the patients will have SMC

Treatment:

Other: Subjective Memory Complain