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临床试验/NCT06109129
NCT06109129招募中不适用

Investıgatıon Of The Effectıveness Of The Mollıı Suıt In Chıldren Wıth Ambulatory Cerebral Palsy: A Double-Blınd Randomızed Controlled Study

Kastamonu University1 个研究点 分布在 1 个国家目标入组 32 人开始时间: 2023年11月5日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
32
试验地点
1
主要终点
The Edinburgh Visual Gait Score (EVGS)

研究概览

简要总结

Cerebral Palsy (CP) is the most common developmental disorder in childhood. Individuals' independence in daily living activities and participation in education, games, social and community activities are restricted. Technology applications in the field of rehabilitation are gaining momentum. EXOPULSE Mollii Suit method, one of the newest rehabilitation technology products, is a non-invasive neuromodulation approach with a garment that covers the whole body and electrodes placed inside. Designed to improve motor function by reducing spasticity and pain, the method is based on the principle of reciprocal inhibition, which occurs by stimulating the antagonist of a spastic muscle at low frequencies and intensities. Therefore, the aim of our study is to examine the effectiveness of the Mollii Suit application on gross and fine motor function, spasticity severity, balance, walking, selective motor control, postural control, daily living activities, quality of life, pain and sleep quality in individuals with ambulatory spastic CP.

详细描述

Cerebral Palsy (CP) is the most common developmental disorder in childhood and is an umbrella term covering a heterogeneous group of permanent but unchanging movement and posture disorders caused by damage to the developing brain. In a study conducted in Turkey in 2006, the incidence was found to be 4.4 per 1000 live births. While difficulties in selective movement negatively affect motor functions, individuals may also experience difficulties in areas such as communication, behavior, vision, hearing, nutrition, pain and sleep. Individuals' independence in daily living activities and participation in education, games, social and community activities are restricted.

In recent years, the number of systematic reviews and meta-analyses focusing on CP treatments has increased rapidly. These studies are instrumental in providing clinicians and families with newer, safer, and more effective interventions. In a systematic review, it was stated that goal-oriented approaches in the development of gross and fine motor skills prioritize motivation and attention, which are important for neuroplasticity, and that this is necessary for the patient to continue treatment. Rehabilitation technologies such as electrotherapy, virtual reality games, and body weight supported treadmill training, which can be combined with targeted motor training, have been shown to be effective on the patient's gross and fine motor functions.

Technology applications in the field of rehabilitation are gaining momentum. The main reasons for this growth include engineering research, commercial development of rehabilitation products and rapidly growing technological developments. These developments are used in CP rehabilitation to improve motor skills, assist with daily living activities, optimize communication and support academic education.

EXOPULSE Mollii Suit method, one of the newest rehabilitation technology products, is a non-invasive neuromodulation approach with a garment that covers the whole body and electrodes placed inside. Designed to improve motor function by reducing spasticity and pain, the method is based on the principle of reciprocal inhibition, which occurs by stimulating the antagonist of a spastic muscle at low frequencies and intensities. No discomfort or side effects were reported in studies conducted in the pediatric population. In one study, they stated that children felt like superheroes in clothes and that it made them feel good. Families stated that this new approach could be an alternative to current treatments and that it was promising.

In the literature, it has only been applied for the treatment of pain and spasticity in patients with CP, stroke, ataxia and fibromyalgia. Different methodological methods were used in these studies and it was stated that there were inconsistencies between the results. According to a pilot study conducted by Hedin et al., 16 patients with CP at different levels were treated for 60 minutes every other day for 6 weeks, and it was observed that there was a significant decrease in joint range of motion and spasticity severity.

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)

盲法说明

All assessments will be performed by an experienced pediatric physiotherapist blinded to the study hypothesis and design.

Statistical analysis of the study will be performed by a biostatistician blinded to the study hypotheses.

入排标准

年龄范围
4 Years 至 18 Years(Child, Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Being a voluntary participant in the study,
  • •Having a diagnosis of spastic CP,
  • •Being between 1-3 on the Gross Motor Classification System (GMFCS),
  • •Being between the ages of 4 and 18,
  • •Being able to express pain and discomfort

排除标准

  • •Being between 4-5 on Gross Motor Classification System (GMFCS)
  • •Having Botolunim Toxin A application before 3 months
  • •Having a surgical intervention before 6 months
  • •Having a shunt or an invasive medical pump (baclofen, insulin, etc.)

研究组 & 干预措施

Intervention Group

Experimental

First group will participate in the Mollii Suit application for 60 minutes 3 days a week. Mollii Suit consists of a pair of trousers and a jacket. It is a neuromodulation garment consisting of a non-invasive removable control unit that sends electrical signals to the user through electrodes inside. The child will wear the Molli Suit when he/she comes to each session, and the child will be asked to sit or lie down throughout the application in order to avoid any interference with the effectiveness of the suit.

干预措施: EXOPULSE Mollii Suit (Device)

Control Group

No Intervention

The control group will continue the routine pediatric physiotherapy program 3 days a week. This program, which includes exercises appropriate to the child's motor function level, includes stair climbing, walking exercises, balance, strengthening and flexibility exercises.

结局指标

主要结局

The Edinburgh Visual Gait Score (EVGS)

时间窗: 10-15 minutes

Set up one of the cameras at the end of the 8m walkway track line to capture a coronal view. Place the second camera facing the center of the walkway to capture the sagittal view. The second camera should be set far enough away so as to capture the middle four meters of each trial. A patient should be able to complete two full strides in this distance. Adjust the cameras to be level with the height of the patient's greater trochanter. Record the patient walking back and forth along the walkway. The patient should be barefoot. Open the video recordings in any video player software and take screenshots of each gait cycle event from both coronal and sagittal views. There are 17 observational parameters that should be measured. Each parameter is scored based on either observed condition or measured joint angles. A three-point scale is used for each parameter. After scores have been assigned for each parameter, all scores should be summed.

次要结局

  • Functional Independence Measure for Children (WeeFIM)(10-15 minutes)
  • Selective Control Assessment of the Lower Extremity (SCALE)(15 minutes)
  • The Gross Motor Function Measure (GMFM)(45-60 minutes)
  • Tardieu Scale(10-15 minutes)
  • The Cerebral Palsy Quality of Life Questionnaire (CP QOL)(15-20 minutes)
  • The Wong-Baker Faces Pain Rating Scale(1-3 minutes)
  • Modified Functional Reach Test(3-5 minutes)
  • Pittsburgh Sleep Quality Index (PSQI)(10-15 minutes)
  • Trunk Control Measurement Scale (TCMS)(15-20 minutes)
  • Modified Timed Up and Go Test(3-5 minutes)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Hidayet Cuha

Lecturer (PHd student)

Kastamonu University

研究点 (1)

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