Completed

PROTMAInterest of the Reborn® Doll as a Therapeutic Object in the Care of Residents With Alzheimer's Disease or a Related Disorder : Pilote Study

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What is being tested

Reborn doll (Therapeutic object - OT)

Device
Who is being recruted

Aberrant Motor Behavior in Dementia+18

+ Alzheimer Disease

+ Behavior

Over 65 Years
+7 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Supportive Care Study

Interventional
Study Start: September 2024
See protocol details

Summary

Principal SponsorUniversity Hospital, Clermont-Ferrand
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: September 16, 2024

Actual date on which the first participant was enrolled.

Dementia is a condition that affects millions of people around the world, and its prevalence is expected to increase as populations age. The World Health Organization anticipates that by 2030, 82 million people will be living with dementia. Currently, there is no cure for this condition, but there are ways to manage its symptoms. This study explores the use of a Reborn® doll as a non-drug therapy to help soothe individuals with Alzheimer's disease or similar disorders. The idea is to provide an alternative to medication by using the doll to reduce symptoms like agitation and aggression, potentially improving the quality of life for those affected. Participants in the study interact with the Reborn® doll, which is designed to look and feel like a real baby. Caregivers use the doll to help calm residents experiencing anxiety or aggressive behavior. The study examines how focusing on the doll can help reduce the need for physical restraints or medication. The results are measured by observing changes in the residents' behavior and emotional responses when they engage with the doll. While there are no specific risks outlined, the potential benefit lies in providing a soothing effect and improving the overall well-being of individuals with dementia.

Official TitleInterest of the Reborn® Doll as a Therapeutic Object in the Care of Residents With Alzheimer's Disease or a Related Disorder : Pilote Study
NCT06396377
Principal SponsorUniversity Hospital, Clermont-Ferrand
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

24 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Supportive Care Study

These studies explore ways to improve comfort and daily life for people living with a condition. They may focus on easing symptoms, reducing treatment side effects, or supporting overall well-being.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 65 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Aberrant Motor Behavior in DementiaAlzheimer DiseaseBehaviorMental DisordersBehavioral SymptomsBrain DiseasesCentral Nervous System DiseasesCognition DisordersDementiaNervous System DiseasesNeurologic ManifestationsPsychomotor AgitationPsychomotor DisordersSigns and SymptomsPathological Conditions, Signs and SymptomsNeurodegenerative DiseasesNeurobehavioral ManifestationsNeurocognitive DisordersDyskinesiasTauopathiesCognitive Dysfunction

Criteria

5 inclusion criteria required to participate
Resident aged 65 and over
Moderate to severe cognitive impairment diagnosed using the NPI-ES scale
Behavioral disorders (agitation, aggression, anxiety, apathy) assessed using the NPI-ES scale
Covered by a social security plan
Show More Criteria
2 exclusion criteria prevent from participating
Resident or representative refusing to participate
Resident under judicial protection

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
The investigating team will give the Reborn®doll to the resident, during a 45-minute to 1-hour workshop, twice a week for 3 weeks. The OTs, wrapped in a blanket, are presented to the residents by a member of the investigative team trained in reborning , in the resident's room. If the resident is not in his/her room, he/she will be taken back to receive his/her doll. In the case of double rooms, it will be necessary to assess whether or not to leave the room-mate in the room, in order to limit the loss of reference points for the resident concerned by the study. The caregiver lets the resident appropriate and recognize the OT, so that he or she can find meaning in it and awaken his or her sensory memory.In total, the patient will be exposed to OT 6 times.

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Suspended

CHU de Clermont-Ferrand

Clermont-Ferrand, FranceOpen CHU de Clermont-Ferrand in Google Maps
CompletedOne Study Center