Cognitive DeclineDUAL-RehabNCT06290167
A New 360° Dual-task Based Protocol for the Pre-clinical In-hospital and At-home Rehabilitation of Elderly: DUAL-Rehab
A study testing 360° media, Treatment As Usual (TAU) and In hospital sessions in people with Cognitive Decline, run by Istituto Auxologico Italiano at 1 site in Italy.
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. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Cognitive Decline
- What is being tested?
- 360° media, Treatment As Usual (TAU) and In hospital sessions
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteItaly
- Study dates
- 3 Jul 2023to 10 Apr 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- > 65 years old
- self-reported memory complaints
- score on Mini-Mental State Examination greater than or equal to 27/30 (normal range)
- > 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.
Who cannot join
- no evidence of objective impairments on the neuropsychological testing, scores on the Clinical Dementia Rating < 0.5
- no dementia
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
Istituto Auxologico Italiano IRCCS
Milan, MI, 20149
Elisa Pedroli, PsyD, 02 61911 2707, e.pedroli@auxologico.it
About this study
The main objective of this project is two-fold
- to develop a Dual-Task training exploiting the potentiality of the 360° technology in terms of interactivity and ecological validity
- 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.
Read more
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.
- Conditions
- Cognitive Decline
- Being tested
- 360° media, Treatment As Usual (TAU), In hospital sessions, at home sessions, Mild Cognitive Impairment
- Medical subject headings
- Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
360° mediaDevice
sessions with head mounted display in hospital and sessions with tablet at home
Treatment As Usual (TAU)Other
sessions of TAU rehabilitation in hospital and sessions TAU rehabilitation at home
In hospital sessionsOther
sessions will be carried out under the supervision of a therapist
at home sessionsOther
sessions will be carried out without the supervision of a therapist
Mild Cognitive ImpairmentOther
half of this group will perform the protocol with 360° videos and the other half will perform the TAU
Subjective Memory ComplainOther
half of this group will perform the protocol with 360° videos and the other half will perform the TAU
| Study group | Role | What they receive |
|---|---|---|
| 360° media | Experimental | All participants will be randomly assigned to 360° media or TAU condition Receives: Device: 360° media |
| Treatment As Usual (TAU) | Active comparator | All participants will be randomly assigned to TAU or 360° media condition Receives: Other: Treatment As Usual (TAU) |
| In hospital sessions | Other | all participants will perform session in hospital Receives: Other: In hospital sessions |
| at home sessions | Other | all participants will perform session at home Receives: Other: at home sessions |
| Mild Cognitive Impairment | Other | half of the patients will have MCI Receives: Other: Mild Cognitive Impairment |
| Subjective Memory Complain | Other | half of the patients will have SMC Receives: Other: Subjective Memory Complain |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cognitive functions
Improvement in cognitive functioning assessed with a complete neuropsychological battery focused on different domains such as executive function, memory, and attention.
Measured: Immediately after the training experience
Motor functions
Improvement in motor functioning assessed with specific test focused on balance, functional mobility, and walking speed
Measured: Immediately after the training experience
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2024
- Study start3 Jul 2023
- Primary completion10 Apr 2026 (estimated)
- Study completion10 Apr 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cognitive DeclineStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind
- Who is masked
- Care provider, Outcomes assessor
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istituto Auxologico Italiano
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06290167
- Sponsor's protocol ID
- 30M201
- Acronym
- DUAL-Rehab
- Status last verified
- Aug 2025
- First submitted
- 6 Oct 2023
- Last updated
- 4 Aug 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A New 360° Dual-task Based Protocol for the Pre-clinical In-hospital and At-home Rehabilitation of Elderly: DUAL-Rehab
- ClinicalTrials.gov ID
- NCT06290167
- Acronym / sponsor ID
- DUAL-Rehab / 30M201
- Conditions
- Cognitive Decline
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Istituto Auxologico ItalianoUniversity, hospital or other
- Study start
- 3 Jul 2023 (actual)
- Primary completion
- 10 Apr 2026 (estimated)
- Study completion
- 10 Apr 2026 (estimated)
- First posted
- 4 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The main objective of this project is two-fold
- to develop a Dual-Task training exploiting the potentiality of the 360° technology in terms of interactivity and ecological validity
- 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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind (care provider, outcomes assessor)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| 360° media | Experimental | Device: 360° mediaAll participants will be randomly assigned to 360° media or TAU condition |
| Treatment As Usual (TAU) | Active comparator | Other: Treatment As Usual (TAU)All participants will be randomly assigned to TAU or 360° media condition |
| In hospital sessions | Other | Other: In hospital sessionsall participants will perform session in hospital |
| at home sessions | Other | Other: at home sessionsall participants will perform session at home |
| Mild Cognitive Impairment | Other | Other: Mild Cognitive Impairmenthalf of the patients will have MCI |
| Subjective Memory Complain | Other | Other: Subjective Memory Complainhalf of the patients will have SMC |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (7 listed)
- > 65 years old
- self-reported memory complaints
- score on Mini-Mental State Examination greater than or equal to 27/30 (normal range)
- > 65 years old
- a self-reported (or reported by a caregiver) cognitive decline
Key exclusion criteria (2 listed)
- no evidence of objective impairments on the neuropsychological testing, scores on the Clinical Dementia Rating < 0.5
- no dementia
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 360° mediasessions with head mounted display in hospital and sessions with tablet at home | Device | 360° media |
| Treatment As Usual (TAU)sessions of TAU rehabilitation in hospital and sessions TAU rehabilitation at home | Other | Treatment As Usual (TAU) |
| In hospital sessionssessions will be carried out under the supervision of a therapist | Other | In hospital sessions |
| at home sessionssessions will be carried out without the supervision of a therapist | Other | at home sessions |
| Mild Cognitive Impairmenthalf of this group will perform the protocol with 360° videos and the other half will perform the TAU | Other | Mild Cognitive Impairment |
| Subjective Memory Complainhalf of this group will perform the protocol with 360° videos and the other half will perform the TAU | Other | Subjective Memory Complain |
Primary outcome
Cognitive functions
Time frame: 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
Time frame: Immediately after the training experience
Improvement in motor functioning assessed with specific test focused on balance, functional mobility, and walking speed
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Aug 2025.
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EFFECTS OF AN OUTDOOR MAT PILATES PROGRAM ON NEUROPHYSIOLOGICAL INDICATORS OF ELDERLY INDIVIDUALS WITH MILD COGNITIVE IMPAIRMENT
Cognition Disorders
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 360° media, Treatment As Usual (TAU) and In hospital sessions in people with Cognitive Decline, run by Istituto Auxologico Italiano at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 4 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Elisa Pedroli, PsyD (02 61911 2707, e.pedroli@auxologico.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cognitive functions (time frame: Immediately after the training experience). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Aug 2025.