3D-printed cutlery handles to help patients eat more independently in rehabilitation

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

This trial tests whether 3D-printed adapted cutlery handles help inpatients with neurodegenerative diseases eat more independently and consume more food during meals.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 75 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer (Academic / other)
• Locations: 2 sites (Hyères, Var and 1 other locations)
• Trial ID: NCT07087574 on ClinicalTrials.gov

What this trial studies

Hospitalized patients in continuing and rehabilitation care who need help at mealtimes receive an occupational therapy hand assessment to choose a 3D-printed cutlery handle (25, 30, 35 or 40 mm). Food intake is measured by a dietician at a baseline lunch without the aid (Day 0), at the first lunch using the adapted handle (Day 1), and after three days of use (Day 3) to capture a learning effect. The ergotherapist scores eating autonomy using the Katz eating item and performs ecological observations on Day 0 and Day 3 to document compensatory movements. Lunches are standardized across the three days to keep conditions consistent.

Who should consider this trial

Good fit: Adults (≥18) hospitalized in a continuing and rehabilitation unit with a neurodegenerative disease, Mini Mental State Examination >15, and a Katz eating score of ≥3 who can use their hands and do not object to participation are ideal candidates.

Not a fit: Patients who cannot use their hands (e.g., amputation or paralysis), who are under legal protection, or who already eat independently are unlikely to benefit from this adapted cutlery approach.

Why it matters

Potential benefit: If successful, the intervention could increase independent eating, raise food intake, and help reduce undernutrition in hospitalized patients with neurodegenerative disease.

How similar studies have performed: Previous work with adapted utensils and larger-handle cutlery has shown improvements in independence and intake for older adults and people with motor impairments, though individualized 3D-printed handles are less widely studied.

Eligibility criteria

Inclusion Criteria:

1. Patient hospitalized in a Continuing Care and Rehabilitation department ;
2. Patient suffering from a neurodegenerative disease (Mini Mental Test score \> 15);
3. Age ≥ 18 years;
4. Patient with a score ≥ 3 on the "Eating" criterion of the Katz scale (corresponding to the need for at least partial assistance with meals).

Exclusion Criteria:

1. Opposition of the patient or his relatives to participating in the research ;
2. Patient unable to use hands to eat (amputation, paralysis, etc.);
3. Patient under court protection;
4. Pregnant, parturient or breast-feeding woman;
5. Any other reason which, in the opinion of the investigator, could interfere with the evaluation of the study objectives.

Where this trial is running

Hyères, Var and 1 other locations

• SSR Pierre Chevalier — Hyères, Var, France (Recruiting)
• Hôpital Georges Clemenceau — La Garde, Var, France (Recruiting)

Study contacts

• Study coordinator: Sophie Lafond

Conditions Neuro-Degenerative Disease