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Идёт набор NCT07666204

Using Sensorimotor Reorganization Following Upper Limb Amputation to Improve Prosthetic Control

Без фазы С лечением Amputation of Upper Limb Agenesis of Upper Limb

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Caracterisation, Mapping, Phantom sensations, Classification.
Кому может быть актуально
Состояния в реестре: Amputation of Upper Limb, Agenesis of Upper Limb. Базовые параметры: от 18 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Франция
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

Обзор

Amputation of an upper limb results in a disruption of the sensorimotor loop and a reorganization of the nervous system, leading to the emergence of a phantom limb and the adaptation of compensatory motor strategies. This project aims to leverage these phenomena (induced sensations, phantom mobility, and compensations) to improve control, sensory feedback, and the appropriation of prostheses, in order to reduce cognitive load and musculoskeletal disorders.

Вмешательства

  • Другое Caracterisation
    The objective of this phase is to identify, from a population of individuals with upper limb amputations, a sufficient number of participants who experience non-painful phenomena related to their phantom limb (sensations, mobility, etc.) prior to the subsequent phases. This phase takes the form of a semi-structured individual interview conducted by one of the study investigators.
  • Другое Mapping
    The objective of this phase is to study the phenomenon of induced phantom sensations in individuals who reported experiencing such sensations during the previous phase. This phase involves a systematic exploration of the areas of the residual limb whose stimulation induces non-painful phantom sensations, as well as the type of sensations thus induced.
  • Другое Phantom sensations
    The goal of this phase is to determine whether stimulation of the residual limb that induces sensations in the phantom limb can help people with lower-limb amputations use their prostheses more effectively.
  • Другое Classification
    The objective of this phase is to characterize the influence of voluntary movements of the residual limb on the myoelectric activity associated with phantom limb mobility. Myoelectric activity and cognitive load will be assessed
  • Другое Prosthetic control
    The objective of this phase is to evaluate the performance of a prosthetic control method based on phantom limb movement in individuals with upper limb amputations. The principle behind this method is to control the movements of the prosthesis using the corresponding movements of the phantom limb, by utilizing the myoelectric activity that can be measured on the residual limb during voluntary phantom limb movements.
  • Другое motor compensations
    The objective of this phase is to characterize and quantify the compensatory movements associated with the use of a conventional myoelectric upper limb prosthesis. The participant will perform the manipulation tasks defined in the SHAP method, as well as the clothespin displacement test.
  • Другое Use of motor reorganization and compensation
    The objective of this phase is to evaluate the performance of a prosthesis control method based on the compensatory movements associated with the use of an upper limb prosthesis. During this phase, participants will not use their personal prostheses but rather an experimental prosthesis developed by the investigators specifically for this study. The experimental prosthesis will be programmed to implement the control method based on compensatory movements, which is the focus of this evaluation.

Первичные конечные точки

  • Characterization of phantom limb [Срок оценки: Baseline (Phase 1 session) ; optional repeat assessment at 6 months]
Вторичные конечные точки (3)
  • NASA TLX Score [Срок оценки: Administered at the end of each experimental sequence, up to 6 months]
  • Southampton Hand Assessment Procedure (SHAP) [Срок оценки: At each evaluation session, up to 6 month]
  • Clothespin Relocation Test (CRT) [Срок оценки: At each evaluation session, up to 6 months]

Критерии участия

Критерии включения

  • people aged 18 or more
  • amputation or agenesis of one uper limb, above the wrist or higher
  • understanding of the French language and the ability to express onself in that language (for semi-structured interviews)
  • affiliation to a social security programm

Критерии исключения

  • history of progressive psychiatric or neurological disorders or disorders with residual effects
  • pregnant or breastfeeding woman
  • minor
  • an adult under legal guardianship
  • pain influencing movement (trunk, residual limb, phantom limb, contralateral limb)

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Не применимо
Модель
Одна группа
Маскирование
Открытое
Основная цель
Фундаментальное исследование

Центры проведения

Франция · 2 центра
  • Institut Régional de Médecine Physique et de Réadaptation, Filière Locomoteur — Nancy
  • Fondation Saint-Hélier — Rennes

Публикации

  • Hussaini A, Hill W, Kyberd P. Clinical evaluation of the refined clothespin relocation test: A pilot study. Prosthet Orthot Int. 2019 Oct;43(5):485-491. doi: 10.1177/0309364619843779. Epub 2019 Jul 2. PMID 31264508
  • Kuorinka I, Jonsson B, Kilbom A, Vinterberg H, Biering-Sorensen F, Andersson G, Jorgensen K. Standardised Nordic questionnaires for the analysis of musculoskeletal symptoms. Appl Ergon. 1987 Sep;18(3):233-7. doi: 10.1016/0003-6870(87)90010-x. PMID 15676628
  • Chateaux M, Rossel O, Verite F, Nicol C, Touillet A, Paysant J, Jarrasse N, De Graaf JB. New insights into muscle activity associated with phantom hand movements in transhumeral amputees. Front Hum Neurosci. 2024 Aug 30;18:1443833. doi: 10.3389/fnhum.2024.1443833. eCollection 2024. PMID 39281369
  • Rossel O, Chateaux M, Jarrassé N, Vérité F, Touillet A, Nicol C, Paysant J, and De Graaf JB (2023). Phantom movement training without classifier performance feedback improves mobilization ability while maintaining EMG pattern classification. IEEE Transitions on Medical Robotics and Bionics 5(1): 133-142.
  • Wu CW, Kaas JH. Spinal cord atrophy and reorganization of motoneuron connections following long-standing limb loss in primates. Neuron. 2000 Dec;28(3):967-78. doi: 10.1016/s0896-6273(00)00167-7. PMID 11163280
  • Wu CW, Kaas JH. The effects of long-standing limb loss on anatomical reorganization of the somatosensory afferents in the brainstem and spinal cord. Somatosens Mot Res. 2002;19(2):153-63. doi: 10.1080/08990220220133261. PMID 12088390
  • Qi HX, Stewart Phillips W, Kaas JH. Connections of neurons in the lumbar ventral horn of spinal cord are altered after long-standing limb loss in a macaque monkey. Somatosens Mot Res. 2004 Sep-Dec;21(3-4):229-39. doi: 10.1080/08990220400012588. PMID 15763908
  • Bekrater-Bodmann R, Foell J, Diers M, Kamping S, Rance M, Kirsch P, Trojan J, Fuchs X, Bach F, Cakmak HK, Maass H, Flor H. The importance of synchrony and temporal order of visual and tactile input for illusory limb ownership experiences - an FMRI study applying virtual reality. PLoS One. 2014 Jan 31;9(1):e87013. doi: 10.1371/journal.pone.0087013. eCollection 2014. PMID 24498012

Идентификаторы

NCT: NCT07666204 · 2026-A00233-48

Первоисточники (государственные реестры)

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