Evaluation of ORTHOPUS Partner Arm in People With Disabilities Needing for Robotic Assistance to Compensate for Upper Limb Deficiency

Официальное название

Evaluation of the ORTHOPUS Partner Arm in People With Disabilities Needing for Robotic Assistance to Compensate for Upper Limb Deficiency

Обзор

The study is a prospective, multicenter, interventional, open clinical trial, in Single Case Experimental Design (SCED) in multiple introduction withdrawal, controlled, randomized.

Подробное описание

The function of the upper limb associated with gripping is essential for carrying out activities of daily living (ADL): personal care, productive activities, leisure, etc. The upper limbs therefore have not only a functional dimension (bringing together, moving away, holding, taking, bringing to the mouth, scratching, etc.) but also a social and anthropological one. As such, a limitation of functionality of the upper limb will have a very significant impact on the quality of life, independence, autonomy and participation of the subjects. When the impairment of a function is irreversible, rehabilitation care may involve the use of aids that either optimize or replace the function. Thus, the orthoses or devices used can either assist the movement if a minimum of muscular strength and control is still present, or completely replace the function if the functional deficit is complete. Using the proprietary robotic actuator, ORTHOPUS has developed the Partner for people with disabilities, with residual strength in the arm. This device is therefore intended for people with a loss of function in the upper limbs. It supports the mobility of the arm by anti-gravity compensation and must help to regain autonomy during ADLs. The Partner is CE marked and classified as a class 1 MD. The hypothesis of the Clinical Investigation is that the Partner medical device is effective in improving the functional capacities of the equipped upper limb (LM), in patients, children and adults, eligible for a robotic compensation Upper Limb Technical Aid, after a period of use of said technical aid in ecological conditions.

Вмешательства

• Устройство With device
  Medical Device Installation Visit (V2, Day 0 + 21 ± 10 days): This visit, lasting approximately 1.5 hours, takes place in a consultation room at the center. A representative from ORTHOPUS adapts and installs the Partner on the patient's wheelchair, and an initial training session on the use of the medical device is provided. Use of the Medical Device in Ecological Conditions (between V2 and V3): Between Day 21 and Day 42, the patient is invited to use the MD without restrictions in real-life co

Первичные конечные точки

• Personalized functional goal achievement score [Срок оценки: Day 45]

Критерии участия

Критерии включения

• Have a loss of mobility in the upper limb (UL).
• Have minimal functional capacities in the upper limb, defined by a score between 1 and 4 on the Lovett scale for all muscle groups of the arm, except for the hand and wrist.
• Demonstrate effective distal motor skills in the upper limb to be fitted.
• Be an informed patient who has provided signed consent, or in the case of minors, have given assent along with the signed consent of legal guardians.
• A relative must be available for the installation visit, and either the patient or the relative must have the necessary equipment to record videos in ecological conditions (smartphone or tablet).)

Критерии исключения

• Patients with cognitive or behavioral dysfunctions that may compromise adherence to instructions and procedures required for the trial (at the discretion of the investigator clinician).
• Patients already enrolled in an interventional clinical trial.
• History of fractures in the upper limb to be fitted within the six months preceding the inclusion visit in the trial.
• Any conditions or injuries that may interfere with functional assessments.
• Patients under legal guardianship or curatorship.
• Lack of health insurance coverage.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT06828510 · APHP241006 · 2024-A02447-40

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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