Меню
Идёт набор NCT06643273

Evaluation of a Haptic Glove for Assessing Tactile Perception in Post-Stroke Patients

Без фазы С лечением Stroke

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: Robotic rehabilitation, Conventional rehabilitation.
Кому может быть актуально
Состояния в реестре: Stroke. Базовые параметры: 18 лет — 85 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
Италия
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
Официальное название

A Multicenter Randomized Controlled Trial on the Effects of Upper Limb Robotic Rehabilitation on Sensory and Cognitive Impairments in Subjects With Stroke. The SCORES (Sensory and Cognitive Outcomes of Robotic Exercises in Stroke) Study. Evaluation of a Haptic Glove.

Обзор

The aim of the SCORES Haptic Glove Study is to assess the technical features, safety, and reliability of a sensor-equipped glove designed to evaluate tactile perception. This will help guide further technical and functional improvements to finalize the device. The secondary goal is to validate a new tactile sensitivity index based on data collected using the glove. This will be done in a randomized controlled multicenter study (ClinicalTrials.gov ID NCT06109324) aimed to compare the effectiveness of robotic upper limb rehabilitation to conventional treatment in improving cognitive and sensory deficits, as well as evaluating the impact of these deficits on motor recovery.

Подробное описание

Sensory and proprioceptive deficits in the upper limbs affect about 50-85% of stroke survivors. These deficits can impact single sensations (such as primary tactile senses like light touch, pressure, and localization) and the ability to discriminate between different materials or temperatures, as well as proprioception and multiple somatosensory modalities. Furthermore, somatosensory deficits have been strongly correlated with variations in treatment responses among patients. However, in clinical practice, the use of appropriate quantitative tools to measure these deficits is not widespread, and evidence for active sensory training remains limited.

In recent years, robotic therapy has been proposed as an effective approach for upper limb rehabilitation. Nevertheless, recent studies with large samples have failed to demonstrate the superiority of robotic treatment over traditional methods regarding the recovery of upper limb motor functions. These studies primarily focus on motor aspects of stroke recovery, often neglecting sensory and cognitive aspects of rehabilitation, whether robotic or conventional.

Actually, there is limited evidence supporting the superiority of robotic approaches over conventional rehabilitation in recovering cognitive deficits and sensitivity. Additionally, it remains unclear whether cognitive and/or sensory deficits impact motor outcomes differently when using robotic versus conventional approaches.

To address this, the SCORES (Sensory and Cognitive Outcomes of Robotic Exercises in Stroke) study is a multicenter randomized controlled study investigating the effects of robotic rehabilitation on cognitive and sensory deficits in stroke survivors. It aims to compare robotic and conventional rehabilitation approaches regarding cognitive recovery and tactile sensitivity in subacute stroke patients. While some quantitative methods exist to assess absolute perception levels of tactile stimuli, standardized, repeatable, and objectively quantitative methods for assessing localization ability are lacking. Therefore, this study will evaluate how the tactile perceptual abilities of recruited patients evolve during and after a rehabilitation course-whether robotic or conventional-using a specifically developed haptic device that includes a glove with integrated vibrotactile elements. This system aims to objectively define patients' tactile sensitivity through psychophysical evaluations involving the identification and localization of randomized vibrations delivered to the surface of the hand affected by sensorimotor alterations. Specifically, this study will investigate the test-retest reliability, discriminant ability, responsiveness, and clinical validity of the metrics obtained from the haptic glove.

During each experimental session, randomized vibrotactile stimuli will be administered to the recruited patient at different sites on the hand. The patient will be asked to identify and verbally communicate the site of each perceived vibration, as well as the intensity of the vibration itself between the two possible levels.

Вмешательства

  • Другое Robotic rehabilitation
    Upper limb rehabilitation using a set of 4 devices. A set of motor/cognitive exercises will be selected to train also attention, memory, executive function, speed of processing, and visuospatial abilities.The following devices will be used: (a) a robotic device that allows passive, active, and active-assistive planar movements of the shoulder and elbow joints (Motore, Humanware); (b) a robotic device that allows passive, active, and active-assistive finger flexion and extension movements (Amadeo
  • Другое Conventional rehabilitation
    Upper limb rehabilitation using conventional techniques, focused on upper limb reprogramming sensorimotor function, hypertonus, inhibition and functional improvement. The rehabilitation treatment will be performed daily for 45 minutes, 5 days/week, for a total of 30 sessions.

Первичные конечные точки

  • Number and types of the haptic glove malfunctions that occurred during the study, along with their descriptions (Feasibility evaluation) [Срок оценки: Baseline; within 2 days after the end of rehabilitation treatment; within 2 days after the end of rehabilitation treatment; 6 months after the end of treatment.]
Вторичные конечные точки (3)
  • Number of stimulations provided by the haptic glove and correctly identified in terms of intensity and localization (test-retest reliability) [Срок оценки: Baseline; within two day after baseline]
  • Number of stimulations correctly identified in terms of intensity and localization (responsiveness) [Срок оценки: Baseline; within 2 days after the end of rehabilitation treatment; 6 months after the end of treatment.]
  • Number of stimulations correctly identified in terms of intensity and localization (clinical validity) [Срок оценки: Baseline; within 2 days after the end of rehabilitation treatment.]

Критерии участия

Критерии включения

  • a single event, verified by MRI or CT;
  • age between 18 and 85 years;
  • time since stroke within six months;
  • a demographically adjusted total score of the Montreal Cognitive Assessment (MoCA) between 15.5 and 22.23

Критерии исключения

  • behavioural and cognitive disorders and/or reduced compliance that would interfere with active therapy;
  • fixed contraction deformity in the affected limb that would interfere with active therapy (ankylosis, Modified Ashworth Scale = 4);
  • severe deficits in visual acuity.

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Двойное слепое
Основная цель
Лечение

Центры проведения

Италия · 3 центра
  • IRCCS Fondazione Don Carlo Gnocchi — Florence
  • IRCCS Centro Neurolesi Bonino Pulejo — Messina
  • Fondazione Don Carlo Gnocchi - Centro Santa Maria della Provvidenza — Roma

Идентификаторы

NCT: NCT06643273 · SCORES-haptic glove · GR-2021-12374896

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗