A New 360° Dual-task Based Protocol for the Pre-clinical In-hospital and At-home Rehabilitation of Elderly: DUAL-Rehab
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: 360° media, Treatment As Usual (TAU), In hospital sessions, at home sessions.
- Who it may be relevant to
- Registry conditions: Cognitive Decline. Basic parameters: from 65 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Italy
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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
- 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 - Other In hospital sessions
sessions will be carried out under the supervision of a therapist - Other at home sessions
sessions will be carried out without the supervision of a therapist - 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 this group will perform the protocol with 360° videos and the other half will perform the TAU
Primary outcome measures
- Cognitive functions [Time frame: Immediately after the training experience]
- Motor functions [Time frame: Immediately after the training experience]
Eligibility 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Factorial
- Masking
- Double blind
- Primary purpose
- Treatment
Study locations
Italy · 1 center
- Istituto Auxologico Italiano IRCCS — Milan
Identifiers
NCT: NCT06290167 · 30M201