Effects of Lokomat-Robot Assisted Gait Training on Gross Motor Function in Children and Young Adults With Cerebral Palsy
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 96
- 试验地点
- 1
- 主要终点
- Standing and walking functions
研究概览
简要总结
This single-center, controlled, delayed-intervention, quasi-experimental study evaluates the effectiveness of Lokomat®-assisted robotic gait training on gross motor function and health-related quality of life in children and young adults with cerebral palsy.
Although previous studies have reported improvements in walking ability, gross motor function, and lower limb performance following Lokomat-assisted gait training, uncertainty remains regarding the optimal treatment intensity and dosing schedule, particularly across different age groups and levels of functional impairment.
The primary objective of this study is to evaluate the effect of a 20-session (8 week) Lokomat-assisted gait training program on standing and walking function, assessed using Dimensions D and E of the Gross Motor Function Measure (GMFM-88). Secondary objectives include evaluation of lower limb muscle strength, walking speed, health-related quality of life, individualized rehabilitation goal attainment, and objective gait training parameters recorded by the Lokomat® system.
The study employs a controlled, delayed-intervention, quasi-experimental design conducted over three consecutive study periods. During each study period, one intervention group receives Lokomat-assisted gait training in addition to usual rehabilitation, whereas a concurrent control group receives usual rehabilitation alone. As standard (usual) rehabilitation participants receive nationally approved standard-of-care rehabilitation, which may include neurorehabilitation, physiotherapy, and/or educational (pedagogical) rehabilitation, as appropriate to their individual clinical needs and routine care.
After completion of the control period and post-intervention assessment, participants in the control group receive the same 20-session Lokomat-assisted gait training program and physiotherapy program during the subsequent study period. Participants allocated to the control group during the final study period receive the intervention after completion of the formal study period.
详细描述
Motor learning theory and contemporary neurorehabilitation emphasize that intensive, task-specific, repetitive practice is essential for promoting neuroplasticity and improving functional motor performance in individuals with neurological disorders. Robot-assisted gait training has therefore become an increasingly important component of pediatric neurorehabilitation by enabling highly repetitive, standardized, and individualized gait practice while reducing the physical burden on therapists.
The Lokomat® robotic gait orthosis combines body-weight-supported treadmill training with computer-controlled lower limb guidance, allowing precise adjustment of walking speed, robotic assistance, and body-weight support according to each participant's functional abilities. Previous studies have demonstrated beneficial effects of Lokomat-assisted gait training on gait performance, gross motor function, endurance, and lower limb function in children with cerebral palsy. However, the available literature shows considerable variability regarding intervention frequency, treatment intensity, total number of sessions, and participant characteristics. Consequently, no consensus currently exists regarding the optimal therapeutic dose for different age groups and functional severity levels.
The intervention dose selected for the present study consists of 20 treatment sessions delivered over approximately eight weeks. This treatment schedule was determined based on two complementary considerations. First, it reflects the clinical experience of this treatment intensity has proven feasible and well tolerated in routine clinical practice. Second, the selected dose is consistent with the range of intervention protocols most frequently reported in published pediatric Lokomat studies, thereby allowing comparison of the present findings with the existing literature while evaluating the practical applicability of this protocol in a real-world rehabilitation setting.
Study Objectives
The primary objective of this study is to evaluate the effectiveness of Lokomat-assisted robotic gait training on standing and walking function in children and young adults with cerebral palsy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 3 Years 至 23 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children and young adult with cerebral palsy (GMFCS II-IV)
- •Age between 3-23 years, of both genders
- •Minimum length of femur: 21 centimeters
- •Hip X-ray not older than 3 months
- •Orthopedic specialist opinion and recommendation for robotic therapy treatment not older than one month
- •Valid medical referral for robotic therapy treatment
- •Signed consent form from the parent/custodian
排除标准
- •Gross motor function classification GMFCS I or GMFCS V
- •Participation in robotic therapy at another location during the control group
- •The safety regulations and contraindications specified by the manufacturer are fully taken into account when using the Lokomat® robotic-assisted gait training system used in the study
- •The main contraindications for the use of Lokomat® include:
- •significant bone mineral density loss (osteopenia, osteoporosis) and increased fracture risk;
- •unhealed or unstable bone fractures; fixed joint contractures that significantly limit the range of motion;
- •medical conditions that prevent active rehabilitation participation (e.g. acute infection, severe respiratory or cardiovascular condition, significant cognitive or neuropsychological impairment);
- •anatomical or body size differences that prevent safe use of the device;
- •skin or soft tissue lesions that pose a risk of injury during use of the orthosis or suspension system.
研究组 & 干预措施
Intervention Arm
In this group, participants received robot-assisted therapy and their usual rehabilitation. During the 8 weeks period, participants will accomplish 20 sessions by using the Lokomat robotic gait training system and participate in physiotherapy sessions.
干预措施: Sessions with Lokomat robot-assisted system (Device)
Control Arm
In this group, participants received usual rehabilitation (e.g. conductive education, physiotherapy). Participants in this group accomplished 20 sessions during 8 weeks by using the Lokomat robotic gait training system and participate in physiotherapy.
干预措施: Control arm (Other)
结局指标
主要结局
Standing and walking functions
时间窗: Measurement at 0 weeks and 8 weeks
The Gross Motor Function Measure-88 (GMFM-88) is a validated observational outcome measure specifically developed to assess gross motor function in children with cerebral palsy. The study evaluates Dimensions D (Standing; 13 items) and E (Walking, Running, and Jumping; 24 items). Each item is scored on a 4-point ordinal scale (0 = does not initiate the task, 1 = initiates, 2 = partially completes, 3 = completes the task). Raw scores are converted to percentage scores ranging from 0% to 100% for each dimension. The Dimension D and E percentage scores (0-100%) will be analyzed as continuous variables and summarized using mean and standard deviation (SD). Higher scores indicate better gross motor function.
次要结局
- Lower limb muscle strength(Measurement at 0 weeks, 8 weeks)
- Goal attainment(Measurement at 0 weeks and 8 weeks)
- Functional performance changes measured by walking speed(Measurement at 0 weeks and 8 weeks.)
- Changes in training parameters recorded by the Lokomat system(Measurement at 0 weeks and 8 weeks.)
- Health-related quality of life(Measurement at 0 weeks and 8 weeks.)