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| ID | Type | Description | Link |
|---|---|---|---|
| 2023-A02040-45 | Other Identifier | IdRCB |
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| Name | Class |
|---|---|
| Groupement Interrégional de Recherche Clinique et d'Innovation | OTHER |
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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.
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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| adapted cutlery handle printed with 3D printer | Device | 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:
The patient's participation will end at the end of the Day3 assessments. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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) | Day 3 |
| Amount of food ingested |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Sophie Lafond | Contact | 4 83 77 20 62 | +33 | sophie.lafond@ch-toulon.fr |
| Name | Affiliation | Role |
|---|---|---|
| Nicolas Brocandel | Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| SSR Pierre Chevalier | Recruiting | Hyères | Var | 83400 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30318956 | Background | 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. | |
| 37083458 | Background | Thorsen 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. |
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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. |
| 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. | 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. | Day 3 |
| Hôpital Georges Clemenceau | Recruiting | La Garde | Var | 83130 | France |
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| 5420677 | Background | Katz 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. |
| 14044222 | Background | KATZ 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. |
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