Effects and Mechanisms of Sensory Afferent Electrostimulation on Upper Limb Function in Patients With Hemiparesis
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: SAES, TAU.
- Кому может быть актуально
- Состояния в реестре: Hemiparesis, Unilateral Cerebral Palsy. Базовые параметры: 6 лет — 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
- Швейцария
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
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Обзор
The goal for this project is to investigate the effects of a 5-week SAES therapy in addition to conventional therapy on both behavioural (sensory and motor) and neurological measures and the underlying mechanisms of treatment response. The goal of this project to investigate the effects of a 5-week SAES therapy in addition to conventional therapy. The aim is to investigate whether SAES is more effective than conventional therapy alone in children with hemiparesis. The investigators will assess the efficacy of SAES using novel clinical assessment such as kinematic evaluations and modern neurophysiological measures, namely transcranial magnetic stimulation (TMS) and resting-state functional MRI (rs-fMRI). It will be expected a benefit for children with hemiparesis after SAES training which may lead to improved bimanual and unimanual functions. Benefits have been reported in adults and in preliminary studies also in children. Type of study: Randomised controlled clinical trial Participants with hemiparesis will be included in the study. The study group will receive the SAES training with a glove or adhesive electrodes as a home-based training during 30 minutes per day, 5x/week, for 5 weeks, combined with conventional occupation therapy. Researchers will compare the SAES group with a group of patients with comparable conditions who receive the prescribed conventional occupational therapy and/or physiotherapy (treatment as usual, TAU)
Подробное описание
Children with hemiparesis present with sensory and motor deficits, which negatively affect quality of life and decrease participation in everyday life. To date, no treatment is yet effective to decrease these impairments. A recent systematic review confirms that unimanual and bimanual trainings effectively improve upper limb function in children with hemiparesis. However, it is still challenging to find the best individual training method for children with hemiparesis, as there is much variability in treatment response.
In the present study, the effects and mechanisms of non-invasive electrostimulation of the hand, called Sensory Afferent Electrostimulation (SAES) will be investigated. SAES triggers action potentials in afferent nerve fibres leading to increased sensory afferent input in the sensorimotor regions of the brain. Through this, SAES can enhance excitability of the motor cortex and of upper limb performance. While proven effective in adults after stroke, SAES is safe with promising positive results in a very small study in children with hemiparesis. However, the investigation of efficacy of SAES on sensory and motor functions was so far neglected. Modern stimulation and imaging methods revealed that, whole-hand SAES induced increased strength of corticospinal projections and intracortical change (measured with transcranial magnetic stimulation), which may indicate long-term potentiation mechanisms. Furthermore, in a functional MRI study, SAES induced increased motor cortex activity. Hence, resting state fMRI will allow to understand the efficacy of SAES on the topographically connectivity of the motor and sensorimotor network at rest.
The experimental intervention consists of SAES with a glove or adhesive electrodes (e.g. Cefar Reha X2) at 20Hz, 300µs, intensity between 2-10mA, during 30 minutes per day, 5x/week, for 5 weeks, combined with conventional occupation therapy. The subsequent therapy sessions will take place at home, with in-between telephone checks.
The control intervention (treatment as usual, TAU) consists of the prescribed conventional occupational therapy and/or physiotherapy. The evaluation of the UL sensory and motor function will be conducted at the University Children's Hospital in Bern by blind assessors, expert in the clinical measures, and will take place before and after each intervention period and at 12-weeks follow-up.
Вмешательства
- Другое SAES
The experimental intervention consists of SAES with a glove or adhesive electrodes at 20Hz, 300µs, intensity between 2-10mA, during 30 minutes per day, 5x/week, for 5 weeks, combined with conventional occupation therapy. The subsequent therapy sessions will take place at home, with in-between telephone checks. - Другое TAU
Treatment as usual
Первичные конечные точки
- Bimanual hand function [Срок оценки: 5 weeks (After the treatment)]
Вторичные конечные точки (12)
- Bimanual hand function [Срок оценки: 2 assessments: baseline, follow up (12 weeks)]
- Bimanual hand function in everyday life activities [Срок оценки: 2 assessments: baseline, follow up (12 weeks)]
- Spasticity [Срок оценки: 3 assessments: baseline, after the treatment (5 weeks), follow up (12 weeks)]
- Strength [Срок оценки: 3 assessments: baseline, after the treatment (5 weeks), follow up (12 weeks)]
- Sensitivity [Срок оценки: 3 assessments: baseline, after the treatment (5 weeks), follow up (12 weeks)]
- Unimanual hand function [Срок оценки: 3 assessments: baseline, after the treatment (5 weeks), follow up (12 weeks)]
- Stereognosis [Срок оценки: 3 assessments: baseline, after the treatment (5 weeks), follow up (12 weeks)]
- Hand function during daily activities [Срок оценки: 2 assessments: baseline, after the treatment (5 weeks)]
- Mirror movements [Срок оценки: 3 assessments: baseline, after the treatment (5 weeks), follow up (12 weeks)]
- Hand/wrist position [Срок оценки: 3 assessments: baseline, after the treatment (5 weeks), follow up (12 weeks)]
- Hand/Finger position [Срок оценки: 3 assessments: baseline, after the treatment (5 weeks), follow up (12 weeks)]
- Upper limb kinematic activity [Срок оценки: 2 assessments: baseline, after the treatment (5 weeks)]
Критерии участия
Критерии включения
- Diagnosis of unilateral cerebral palsy/hemiparesis, following unilateral brain lesion, e.g. perinatal/childhood stroke (acquired prior to the age of 16 years)
- consistent and stable limitation of hand functions
- chronic state (time since lesion >2 years)
- aged 6-18 years
- parental informed consent if <14 years, informed consent of the patient if >14 years
Критерии исключения
- psychiatric disease that prevents the participant form informed participation and compliance in an adequate manner/setting
- Bilateral brain lesion
- Recent Botulinum toxin-injections injections (UL, < 6 months)
- Hand surgery on paretic hand < 2 years
- Trauma to UL in the last year
- Medical conditions that prevent training of the UL
- Participation in other afferent stimulation studies
- Electrical stimulation therapy in the last 6 months
- Intensive training of the UL (therapy more than 1x/week, < 6 months)
If MRI and TMS is performed, additionally:
- MRI and TMS contradictions, such as
- implanted Metal devices (e.g. braces, implant)
- implanted shunt system
- in girls and women: pregnancy
- claustrophobia
- Active epilepsy
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
Швейцария · 1 центр
- Inselspital — Bern
Идентификаторы
NCT: NCT06536634 · 2024-00982