Neuro-Degenerative DiseaseAUTARI-3DNCT07087574
3D Printers for Autonomy in the Care of Inpatients in Continuing and Rehabilitation Care
A study testing adapted cutlery handle printed with 3D printer in people with Neuro-Degenerative Disease, run by Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer at 2 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Neuro-Degenerative Disease
- What is being tested?
- adapted cutlery handle printed with 3D printer
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 2 sitesFrance
- Study dates
- 30 Mar 2026to Oct 2027
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
France2 sites, 2 recruiting
- Recruiting
SSR Pierre Chevalier
Hyères, Var, 83400
Clément KERNEVEZ, CKERNEVEZ@mgen.fr
- Recruiting
Hôpital Georges Clemenceau
La Garde, Var, 83130
Nicolas Brocandel, NICOLAS.BROCANDEL@ch-toulon.fr
About this study
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.
Read more
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.
Read the detailed description
Patients hospitalized in CRCU will be informed of the research. Those who do not object to participating in the research and who meet the eligibility criteria will be included.
Their participation will begin with an initial functional and joint assessment of the patient's hand by an occupational therapist to determine the diameter of cutlery handles best suited to the patient's grip (25, 30, 35 or 40 mm).
The patient's autonomy ("Eating" criterion on the Katz scale) will be assessed by the same ergotherapist, and the quantity of food ingested will be measured by a dietician at 3 points:
- During a lunch before using the adapted cutlery handles (Day0);
- At lunch when the adapted cutlery handles are used for the first time (Day1);
- At lunch after 3 days' use of the adapted cutlery handles (Day3), corresponding to the learning phase in the use of the technical aid.
Lunches will be similar over the 3 days. These are standard lunches predefined by the unit's dietician.
On Day0 and Day3, the ergotherapist will carry out an ecological assessment of meals. Ecological assessment is used in ergotherapy 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.
- Conditions
- Neuro-Degenerative Disease
- Being tested
- adapted cutlery handle printed with 3D printer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
adapted cutlery handle printed with 3D printerDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Patient hospitalized in Continuing Care and Rehabilitation Unit | Experimental | Patient suffering from a neurodegenerative disease. Mini Mental Test > 15 and "Eating" criterion of the Katz scale score ≥ 3 Receives: Device: adapted cutlery handle printed with 3D printer |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Day 1
Secondary outcomes (4)
Patients' food autonomy
Patients' food autonomy will be assessed by the same composite criterion defined for the main objective (SUCCES/ECHEC) during a typical lunch, before using the ergonomic cutlery handles (Day 0) and after three days of use (Day 3)
Measured: Day 3
Amount of food ingested
The rate of ingesta over a typical lunch will be quantified by weighing each patient's food before and after meals on Day 0, Day 1 and Day 3. These weighings will be used to calculate the percentage of food ingested during the meal.
Measured: Day 3
Autonomy in food intake ("Eating" criterion)
Patients' autonomy in food intake will be assessed by the "Eating" criterion of the Katz scale during a typical lunch at Day 0, Day 1 and Day 3.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.
Measured: Day 3
Compensations with the upper limb
The presence or absence of compensation with the upper limb at mealtimes will be assessed by an occupational therapist (ecological assessment) with conventional cutlery at Day 0, and after three days' use of ergonomic cutlery handles at Day 3.
Measured: Day 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2025
- Study start30 Mar 2026
- Primary completionOct 2027 (estimated)
- Study completionOct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Neuro-Degenerative DiseaseStudies 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
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 75 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer
- Sponsor type
- University, hospital or other
- Collaborators
- Groupement Interrégional de Recherche Clinique et d'Innovation
- Responsible party
- Sponsor
- Investigators
- Nicolas Brocandel, Study director, Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07087574
- Sponsor's protocol ID
- 2023-CHITS-011
- Other IDs
- 2023-A02040-45
- Acronym
- AUTARI-3D
- Status last verified
- Jul 2026
- First submitted
- 9 Jul 2025
- Last updated
- 7 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 30318956Thorsen 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.
PubMed 37083458Katz 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.
PubMed 5420677KATZ 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.
PubMed 14044222
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 3D Printers for Autonomy in the Care of Inpatients in Continuing and Rehabilitation Care
- ClinicalTrials.gov ID
- NCT07087574
- Acronym / sponsor ID
- AUTARI-3D / 2023-CHITS-011
- Conditions
- Neuro-Degenerative Disease
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- Centre Hospitalier Intercommunal de Toulon La Seyne sur MerUniversity, hospital or other
- Collaborators
- Groupement Interrégional de Recherche Clinique et d'Innovation
- Study start
- 30 Mar 2026 (actual)
- Primary completion
- Oct 2027 (estimated)
- Study completion
- Oct 2027 (estimated)
- First posted
- 28 Jul 2025 (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.
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.
Detailed description
Patients hospitalized in CRCU will be informed of the research. Those who do not object to participating in the research and who meet the eligibility criteria will be included.
Their participation will begin with an initial functional and joint assessment of the patient's hand by an occupational therapist to determine the diameter of cutlery handles best suited to the patient's grip (25, 30, 35 or 40 mm).
The patient's autonomy ("Eating" criterion on the Katz scale) will be assessed by the same ergotherapist, and the quantity of food ingested will be measured by a dietician at 3 points:
- During a lunch before using the adapted cutlery handles (Day0);
- At lunch when the adapted cutlery handles are used for the first time (Day1);
- At lunch after 3 days' use of the adapted cutlery handles (Day3), corresponding to the learning phase in the use of the technical aid.
Lunches will be similar over the 3 days. These are standard lunches predefined by the unit's dietician.
On Day0 and Day3, the ergotherapist will carry out an ecological assessment of meals. Ecological assessment is used in ergotherapy 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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patient hospitalized in Continuing Care and Rehabilitation Unit | Experimental | Device: adapted cutlery handle printed with 3D printerPatient suffering from a neurodegenerative disease. Mini Mental Test > 15 and "Eating" criterion of the Katz scale score ≥ 3 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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).
Key exclusion criteria (5 listed)
- 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.
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 |
|---|---|---|
| adapted cutlery handle printed with 3D printerThe 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. | Device | Patient hospitalized in Continuing Care and Rehabilitation Unit |
Primary outcome
Patients' food autonomy
Time frame: Day 1
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.
4 secondary outcomes
Patients' food autonomy
Time frame: Day 3
Amount of food ingested
Time frame: Day 3
Autonomy in food intake ("Eating" criterion)
Time frame: Day 3
Compensations with the upper limb
Time frame: Day 3
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 7 Jul 2026.
- Background: PubMed 30318956Lee 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.
- Background: PubMed 37083458Thorsen 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.
- Background: PubMed 5420677Katz 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.
- Background: PubMed 14044222KATZ 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.
- Related InfoLink provided by the sponsor.
- Related InfoLink provided by the sponsor.
- Related InfoLink provided by the sponsor.
- Related InfoLink provided by the sponsor.
- Related InfoLink provided by the sponsor.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
Nicolas Brocandel study director
Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing adapted cutlery handle printed with 3D printer in people with Neuro-Degenerative Disease, run by Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer at 2 sites in France.
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 4 inclusion and 5 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 7 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. 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 Sophie Lafond (4 83 77 20 62 ext. +33, sophie.lafond@ch-toulon.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patients' food autonomy (time frame: Day 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07087574, which also lists 4 linked publications.
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 7 Jul 2026.