The Effect of Robot-assisted Walking Training on Motor Functions, Respiratory Parameters and Functional Capacity in Cerebral Palsy
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Gross Motor Function Measure-88 (GMFM-88)
研究概览
简要总结
An informed consent form was prepared for families regarding the planned research. Permission and signatures were obtained from the parents of children aged 8-16 years who participated in the study.
The study titled "The Effect of Robot-Assisted Walking Training on Motor Functions, Respiratory Parameters and Functional Capacity in Cerebral Palsy" is conducted by Physiotherapist Efe Alcan at the Department of Physiotherapy and Rehabilitation, Faculty of Health Sciences, Istanbul University-Cerrahpaşa. This master's thesis aims to evaluate motor functions, respiratory parameters, and functional capacity in daily life in children with ambulatory type Cerebral Palsy receiving neurodevelopmental treatment (NDT)-based exercises, with or without additional robot-assisted walking training.
The primary objective is to determine the effectiveness of adding robot-assisted gait training to conventional neurodevelopmental treatment on motor and respiratory parameters. The scientific contribution of the study is the quantitative measurement of FEV1, FVC, and FEV1/FVC values using a digital spirometer in children undergoing robot-assisted gait training, thereby providing objective pulmonary data in individuals with Cerebral Palsy.
Interventions include tandem walking, balance exercises, weight transfer exercises in hands-and-knees (cat-camel) position, and proprioceptive exercises. The experimental group additionally performs walking sessions using a robotic gait device. All interventions are supervised by Physiotherapist Efe Alcan and are not expected to involve significant risk.
Following completion of the 12-week intervention program, all baseline assessments are repeated to evaluate treatment-related changes.
A total of 24 children with Cerebral Palsy are expected to participate. Demographic data including age, sex, height, weight, education status, and relevant medical history are recorded at baseline. Participants attend two evaluation sessions (pre- and post-intervention) and a 40-minute rehabilitation session once weekly for 12 weeks.
详细描述
Detailed Description
Cerebral Palsy (CP) is a group of permanent disorders affecting movement, posture, and motor control caused by non-progressive disturbances in the developing brain. In addition to motor impairments such as spasticity, muscle weakness, and impaired balance, children with CP frequently demonstrate reduced cardiopulmonary capacity and decreased endurance during daily activities. Limitations in trunk control, altered gait mechanics, and reduced physical activity levels may negatively influence respiratory function over time. For this reason, modern pediatric rehabilitation approaches increasingly emphasize interventions that address both motor performance and physiological capacity.
Neurodevelopmental treatment (NDT) is one of the most commonly used therapeutic approaches in pediatric neurorehabilitation. The approach focuses on facilitating normal movement patterns, improving postural control, enhancing functional mobility, and promoting participation in daily activities through task-specific exercises and therapist-guided movement strategies. Although NDT-based interventions are widely applied, complementary technologies that increase movement repetition and provide structured gait practice may further enhance rehabilitation outcomes.
Robot-assisted gait training has been developed to deliver repetitive, task-specific walking practice with controlled parameters such as walking speed and body alignment. These systems enable individuals with neurological impairments to practice symmetrical gait cycles while receiving external mechanical support and consistent sensory input. Such repetitive locomotor training may contribute to motor learning, improve walking ability, and potentially increase cardiopulmonary engagement during rehabilitation. However, evidence regarding the combined effects of robot-assisted gait training and conventional neurodevelopmental treatment on both motor and respiratory outcomes in children with Cerebral Palsy remains limited.
This study investigates the effects of adding robot-assisted gait training to a neurodevelopmental treatment-based rehabilitation program in ambulatory children with Cerebral Palsy. The intervention program is designed to target multiple components of functional performance, including postural control, balance, lower-extremity strength, coordination, and breathing mechanics. Participants are allocated into two intervention groups: a neurodevelopmental treatment group and a neurodevelopmental treatment plus robot-assisted rehabilitation group. Both interventions are administered by a physiotherapist experienced in pediatric neurological rehabilitation.
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
- None
入排标准
- 年龄范围
- 8 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children aged 8-18 years with a diagnosis of spastic type cerebral palsy (SP)
- •Classified as Level I-III according to the Gross Motor Function Classification System (GMFCS)
- •Height ≥100 cm to ensure compatibility with robotic device braces
- •Adequate cognitive and behavioral cooperation to participate in exercise sessions
排除标准
- •Musculoskeletal surgery within the past 12 months
- •Botulinum Toxin A injection within the past 6 months
- •History of uncontrolled or irregular epilepsy/seizures
- •Cardiovascular disease contraindicating exercise participation
研究组 & 干预措施
ROBOTIC REHABILITATION GROUP APPLIED IN ADDITION TO NEURODEVELOPMENTAL TREATMENT
LOKOHELP Electromechanical Walking Device was used. This device was developed for locomotor therapy with body weight support on the treadmill. LokoHelp enables individuals to develop correct posture, walking and turning ability without human support. This system provides weight support to the individual and allows them to walk in the correct pattern. In the meantime, a monitor shows us the individual's speed and the distance they have covered in meters during their walk. In order to integrate the individual into the system, they were dressed in clothing and shoes that were appropriate to their measurements.
干预措施: robotic rehabilitation and intensive spirometry (Device)
ROBOTIC REHABILITATION GROUP APPLIED IN ADDITION TO NEURODEVELOPMENTAL TREATMENT
LOKOHELP Electromechanical Walking Device was used. This device was developed for locomotor therapy with body weight support on the treadmill. LokoHelp enables individuals to develop correct posture, walking and turning ability without human support. This system provides weight support to the individual and allows them to walk in the correct pattern. In the meantime, a monitor shows us the individual's speed and the distance they have covered in meters during their walk. In order to integrate the individual into the system, they were dressed in clothing and shoes that were appropriate to their measurements.
干预措施: spirometer spirobank (Device)
Only neurodevelopmental exercise group
This group was given 40 minutes of neurodevelopmental exercises. These exercises are listed as follows:
Balance was worked on by transferring weight to the hips and legs in different positions.
Step strategies towards different directions were worked on. If the patient can do it fully, active, if not, active assisted tandem walking exercises were worked on.
Balance exercises were done on a balance board.
干预措施: spirometer spirobank (Device)
结局指标
主要结局
Gross Motor Function Measure-88 (GMFM-88)
时间窗: 12 week
A total of 88 items are examined in 5 main dimensions: Area Content A Reaching and rolling B Sitting C Crawling and kneeling D Standing E Walking, running and jumping Each item is scored between 0-3 according to how successfully the child performs the task: 0: Cannot do 1 : Partially does 2: Almost completely does 3 : Fully does Determining the level of gross motor function Planning the rehabilitation process Monitoring progress over time and response to therapy Used to provide comparative measurement in clinical research.
次要结局
- Modified Ashworth Scale(The treatment period was 3 months and spasticity values were re-examined at the end of 3 months.)
- 6 minute walk test(It covers the 3-month period from the beginning to the end of the treatment. 3 months includes 12 weeks. An evaluation will be made at the beginning and end of the 12 weeks.)
- MIR SPIROBANK SPIROMETER(Measurements will be taken at the end of 12 weeks.)
研究者
Efe Alcan
Physiotherapist
Istanbul University - Cerrahpasa