Effects and Mechanisms of Sensory Afferent Electrostimulation on Upper Limb Function in Patients With Hemiparesis
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 34
- 试验地点
- 2
- 主要终点
- Bimanual hand function
研究概览
简要总结
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)
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 6 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
- •Exclusion criteria:
- •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
排除标准
- 未提供
研究组 & 干预措施
Control group
The control intervention (treatment as usual, TAU) consists of the prescribed conventional occupational therapy and/or physiotherapy.
干预措施: TAU (Other)
结局指标
主要结局
Bimanual hand function
时间窗: 5 weeks (After the treatment)
Will be measured with the Assisting Hand Assessment (AHA)
次要结局
- Bimanual hand function(2 assessments: baseline, follow up (12 weeks))
- Hand function during daily activities(2 assessments: baseline, after the treatment (5 weeks))
- Mirror movements(3 assessments: baseline, after the treatment (5 weeks), follow up (12 weeks))
- Upper limb kinematic activity(2 assessments: baseline, after the treatment (5 weeks))
- Quality of life of Children with hemiparesis regarding hand function(3 assessments: baseline, after the treatment (5 weeks), follow up (12 weeks))
- Reported Pain(Daily during the treatment phase (duration of treatment phase 5 weeks))
- Bimanual hand function in everyday life activities(2 assessments: baseline, follow up (12 weeks))
- Strength(3 assessments: baseline, after the treatment (5 weeks), follow up (12 weeks))
- Unimanual hand function(3 assessments: baseline, after the treatment (5 weeks), follow up (12 weeks))
- TMS - Neurophysiological outcomes(2 assessments: baseline, after the treatment (5 weeks))
- MRI - Neurophysiological outcomes(2 assessments: baseline, after the treatment (5 weeks))
- Quality of life of Children with hemiparesis(3 assessments: baseline, after the treatment (5 weeks), follow up (12 weeks))
- Bimanual hand function(2 assessments: baseline, follow up (12 weeks))
- Spasticity(3 assessments: baseline, after the treatment (5 weeks), follow up (12 weeks))
- Hand/Finger position(3 assessments: baseline, after the treatment (5 weeks), follow up (12 weeks))
- Bimanual hand function in everyday life activities(2 assessments: baseline, follow up (12 weeks))
- Strength(3 assessments: baseline, after the treatment (5 weeks), follow up (12 weeks))
- Unimanual hand function(3 assessments: baseline, after the treatment (5 weeks), follow up (12 weeks))
- Hand function during daily activities(2 assessments: baseline, after the treatment (5 weeks))
- Hand/wrist position(3 assessments: baseline, after the treatment (5 weeks), follow up (12 weeks))
- Upper limb kinematic activity(2 assessments: baseline, after the treatment (5 weeks))
- MRI - Neurophysiological outcomes(2 assessments: baseline, after the treatment (5 weeks))
- TMS - Neurophysiological outcomes(2 assessments: baseline, after the treatment (5 weeks))
- Sensitivity(3 assessments: baseline, after the treatment (5 weeks), follow up (12 weeks))
- Stereognosis(3 assessments: baseline, after the treatment (5 weeks), follow up (12 weeks))
- Mirror movements(3 assessments: baseline, after the treatment (5 weeks), follow up (12 weeks))
- Quality of life of Children with hemiparesis(3 assessments: baseline, after the treatment (5 weeks), follow up (12 weeks))
- Quality of life of Children with hemiparesis regarding hand function(3 assessments: baseline, after the treatment (5 weeks), follow up (12 weeks))
- Reported Pain(Daily during the treatment phase (duration of treatment phase 5 weeks))