3D Printers for Autonomy in the Care of Inpatients in Continuing and Rehabilitation Care
AUTARI-3D
2 other identifiers
interventional
75
1 country
2
Brief Summary
Patients hospitalized in Continuing and Rehabilitation Care Units (CRCU) are for the most part elderly people suffering from neurodegenerative diseases, requiring individual, personalized rehabilitation care. Some of these patients require ergotherapy to help them regain functional ability in everyday activities. The ergotherapist organizes therapeutic activities tailored to patients' needs, with a view to optimizing their level of autonomy. Loss of autonomy is closely linked to nutritional status, which often tends towards malnutrition in patients admitted to CRCU, with deleterious consequences for the elderly. The use of technical aids to facilitate meal-taking could be a way of alleviating undernutrition. A technical aid is defined as a material aid that enables elderly or disabled people to compensate for a limitation in activity. The investigators are interested in the use of adapted cutlery, as patients often find it difficult to eat on their own, being unable to grip their cutlery correctly. Commercially adapted cutlery exists, but it is expensive and difficult to use because it is not adapted to each patient (standard size) and is too heavy. What's more, the investigators observe that their use does not necessarily improve the patient's degree of dependence, generally measured by the Katz scale. The idea of the team of ergotherapist is to offer ergonomic cutlery handles with diameters adapted to patients' degree of prehension. They offer handles with diameters of 25 mm, 30 mm, 35 mm and 40 mm. The diameter is customized according to the hand's flexion capacity, as assessed by a joint and functional assessment. What's original about these technical aids is that they are designed from thermoformable materials with the help of a 3 Dimension printer and Computer-Aided Design and Manufacturing software, in partnership with the Fablab (Fabrication laboratory) in Toulon and the Hyères media library. They have the added advantage of being lightweight and inexpensive.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Mar 2026
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 9, 2025
CompletedFirst Posted
Study publicly available on registry
July 28, 2025
CompletedStudy Start
First participant enrolled
March 30, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
October 1, 2027
April 13, 2026
April 1, 2026
1.5 years
July 9, 2025
April 9, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
Patients' food autonomy
Eating autonomy is defined by a composite criterion that simultaneously takes into account the following 2 criteria: improvement in the Eating criterion of the Katz scale and the variation in the rate of ingesta with conventional cutlery at Day 0, then on first use of adapted ergonomic cutlery at Day 1. The Eating criterion of the Katz scale comprises four levels, scored from 1 to 4. The higher the score, the greater the need for assistance. Only patients with a score greater than or equal to 3 will be included in this research. The use of ergonomic cutlery handles customized and individualized for food autonomy, will be defined as A SUCCESS, if the patient presents an improvement in the Eating criterion of the Katz scale; accompanied by a rate of ingesta at Day 1 not significantly lower than at Day 0 or a stabilization of the Eating criterion of the Katz scale; accompanied by a rate of ingesta at D1 significantly higher than at D0. A FAILURE, if the patient is in any other situation.
Day 1
Secondary Outcomes (4)
Patients' food autonomy
Day 3
Amount of food ingested
Day 3
Autonomy in food intake ("Eating" criterion)
Day 3
Compensations with the upper limb
Day 3
Study Arms (1)
Patient hospitalized in Continuing Care and Rehabilitation Unit
EXPERIMENTALPatient suffering from a neurodegenerative disease. Mini Mental Test \> 15 and "Eating" criterion of the Katz scale score ≥ 3
Interventions
The patient's autonomy will be assessed by the same ergotherapist, and the quantity of food ingested will be measured by a dietician at 3 similar lunch times: * before using the adapted cutlery handles (Day0); * when the adapted cutlery handles are used for the first time (Day1); * after 3 days' use of the adapted cutlery handles (Day3) On Day0 and Day3, the ergotherapist will carry out an ecological assessment of the meals. Ecological assessment is used in occupational therapy to observe and analyze the patient's interactions with his environment and their repercussions on his ability to perform a task. The aim here is to assess whether the patient exhibits compensation of the upper limb (such as shoulder elevation or trunk inclination) during the meal performed without technical aids (Day0) and that performed after the learning phase of using the adapted handle (Day3). The patient's participation will end at the end of the Day3 assessments.
Eligibility Criteria
You may qualify if:
- Patient hospitalized in a Continuing Care and Rehabilitation department ;
- Patient suffering from a neurodegenerative disease (Mini Mental Test score \> 15);
- Age ≥ 18 years;
- Patient with a score ≥ 3 on the "Eating" criterion of the Katz scale (corresponding to the need for at least partial assistance with meals).
You may not qualify if:
- Opposition of the patient or his relatives to participating in the research ;
- Patient unable to use hands to eat (amputation, paralysis, etc.);
- Patient under court protection;
- Pregnant, parturient or breast-feeding woman;
- Any other reason which, in the opinion of the investigator, could interfere with the evaluation of the study objectives.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
SSR Pierre Chevalier
Hyères, Var, 83400, France
Hôpital Georges Clemenceau
La Garde, Var, 83130, France
Related Publications (4)
Lee KH, Kim DK, Cha YH, Kwon JY, Kim DH, Kim SJ. Personalized assistive device manufactured by 3D modelling and printing techniques. Disabil Rehabil Assist Technol. 2019 Jul;14(5):526-531. doi: 10.1080/17483107.2018.1494217. Epub 2018 Oct 14.
PMID: 30318956BACKGROUNDThorsen R, Cugnod D, Ramella M, Converti R, Ferrarin M. A parametric 3D printed assistive device for people with cerebral palsy - assessment of outcomes and comparison with a commercial counterpart. Assist Technol. 2024 Jan 2;36(1):16-21. doi: 10.1080/10400435.2023.2202696. Epub 2023 May 22.
PMID: 37083458BACKGROUNDKatz S, Downs TD, Cash HR, Grotz RC. Progress in development of the index of ADL. Gerontologist. 1970 Spring;10(1):20-30. doi: 10.1093/geront/10.1_part_1.20. No abstract available.
PMID: 5420677BACKGROUNDKATZ S, FORD AB, MOSKOWITZ RW, JACKSON BA, JAFFE MW. STUDIES OF ILLNESS IN THE AGED. THE INDEX OF ADL: A STANDARDIZED MEASURE OF BIOLOGICAL AND PSYCHOSOCIAL FUNCTION. JAMA. 1963 Sep 21;185:914-9. doi: 10.1001/jama.1963.03060120024016. No abstract available.
PMID: 14044222BACKGROUND
Related Links
Study Officials
- STUDY DIRECTOR
Nicolas Brocandel
Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 9, 2025
First Posted
July 28, 2025
Study Start
March 30, 2026
Primary Completion (Estimated)
October 1, 2027
Study Completion (Estimated)
October 1, 2027
Last Updated
April 13, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will not share