Design of a Prototype Garment Adapted to Demented Elderly Subjects With Disturbing Behavioral Problems in the Management of Sphincter Disorders

NCT ID: NCT05649839

Last Updated: 2025-09-19

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-12-06
• Study Completion Date: 2026-01-01

Brief Summary

Alzheimer's disease and related disorders (ADRD) are diseases whose frequency is increasing in elderly subjects. Their evolution is marked by the occurrence, in addition to cognitive disorders, of increasingly disruptive behavioral disorders that interfere with their management, as well as impairment of basic functions, including the occurrence of sphincter disorders responsible for daytime and nighttime urinary and fecal incontinence. These disorders are present in more than 80% of LAM patients and are of multifactorial origin.

It is difficult to get patients to accept wearing the necessary protection. They tend to remove or tear them off. This can frequently lead to stressful situations of agitation and inappropriate behavior for patients and uncomfortable continence management for caregivers.

In order not to be forced to use heavy physical restraints or therapeutics that promote drowsiness so that the patient cannot remove his or her protections, the only effective response today is to wear a garment. Unfortunately, the ones that exist today are strictly functional and are worn at night.

The use of such garments, during the day, in this indication, is therefore a common and usual practice today.

This results in an ethical problem for the caregivers. Indeed, worn during the day, rompers give the impression to the latter that they show a devaluing, infantilizing or even degrading image of the elderly person. This practice, although common and accepted because it is the only recourse to physical and chemical restraints to preserve the cleanliness and presentation of elderly patients, could lead to an impaired dignity which could be badly experienced by their close circle of friends and family as well as by the carers and could also have an impact on the overall effectiveness of the care .

This is the first time that a multi-professional team integrating doctors, caregivers, occupational therapists and engineers have reflected on the design of a garment that meets the expectations of caregivers, patients and their families. The romper thus designed must be able to retain the aesthetic characteristics of a garment that meets the tastes of the elderly while respecting their dignity.

Conditions

Adapted Garment Prototype; Elderly; Problem Behavior; Dementia; Sphincter Disorders

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

conventional garment

Group Type: ACTIVE_COMPARATOR

garment

Intervention Type: OTHER

patient randomized in the experimental arm will wear the specially designed garment

prototype garment

Group Type: EXPERIMENTAL

garment

Intervention Type: OTHER

patient randomized in the experimental arm will wear the specially designed garment

Interventions

garment

patient randomized in the experimental arm will wear the specially designed garment

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Patients hospitalized in a cognitive-behavioral unit or long-term care or residents of the EHPAD at the St-Victor center - CHU Amiens-Picardie,
• patients with behavioral and sphincter disorders justifying the prescription of a romper.

Exclusion Criteria

• No next of kin
• Patients in terminal palliative care
• Patients whose morphology does not allow the use of prototypes (no adapted size)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Centre Hospitalier Universitaire, Amiens

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Centre Hospitalier Universitaire d'Amiens

Amiens, Picardie, France

Countries

France

References

Bloch F, Joron E, Boutalha S, Mekchoudi S, Claviere M. Design of a prototype of clothing for older persons with neurocognitive diseases with behavioural troubles interfering with the management of sphincter disorders. Disabil Rehabil Assist Technol. 2025 Apr;20(3):692-698. doi: 10.1080/17483107.2024.2404701. Epub 2024 Sep 18.

Reference Type: RESULT

PMID: 40164140 (View on PubMed)

Other Identifiers

PI2018_843_0053

Identifier Type: -

Identifier Source: org_study_id