3D Printers for Autonomy in the Care of Inpatients in Continuing and Rehabilitation Care

Phase

N/A

Condition

Multiple Sclerosis

Neurologic Disorders

Treatment

adapted cutlery handle printed with 3D printer

Clinical Study ID

NCT07087574

2023-CHITS-011

2023-A02040-45

Ages > 18
All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

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 (correspondingto the need for at least partial assistance with meals).

Exclusion

Exclusion Criteria:

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 theevaluation of the study objectives.

Study Design

adapted cutlery handle printed with 3D printer

February 01, 2026

September 30, 2027

Study 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.

Connect with a study center

SSR Pierre Chevalier
Hyères, Var 83400
France
Active - Recruiting
SSR Pierre Chevalier
Hyères 3012937, Var 83400
France
Site Not Available
Hôpital Georges Clemenceau
La Garde, Var 83130
France
Site Not Available
Hôpital Georges Clemenceau
La Garde 3009223, Var 83130
France
Site Not Available

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