Effects of Lokomat-Robot Assisted Gait Training on Gross Motor Function in Children and Young Adults With Cerebral Palsy

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.

In addition, the study aims to determine whether treatment tolerance and clinical effectiveness differ according to participants' age and functional severity as classified by the Gross Motor Function Classification System (GMFCS). An important objective is to explore whether treatment response differs according to functional severity and age and to provide evidence for the development of a standardized clinical protocol for Lokomat-assisted rehabilitation within pediatric neurorehabilitation.

The study also investigates whether participation in conductive education influences rehabilitation outcomes following robot-assisted gait training.

Study Design

This is a single-center, controlled, delayed-intervention, quasi-experimental study conducted over three consecutive study periods. During each period, one intervention group receives Lokomat-assisted gait training and physiotherapy sessions in addition to usual rehabilitation, whereas a concurrent control group continues usual rehabilitation without robotic gait training. Following completion of the control period and post-intervention assessment, control participants receive the same 20-session intervention 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 assessments, ensuring that all eligible participants have access to the treatment.

Approximately 96 participants with cerebral palsy are expected to be enrolled.

Outcome Measures

The primary outcome is change in standing and walking function measured using Dimensions D (Standing) and E (Walking, Running and Jumping) of the Gross Motor Function Measure (GMFM-88). These dimensions were selected because they specifically assess functional abilities expected to improve following robot-assisted gait training and are widely accepted outcome measures in pediatric cerebral palsy rehabilitation research.

Secondary outcome measures include:

lower limb muscle strength measured using handheld dynamometry to quantify changes in muscle force production; walking speed assessed with the 10-Meter Walk Test as a clinically relevant measure of functional mobility; health-related quality of life assessed using the Pediatric Quality of Life Inventory (PedsQL), providing information regarding the participant's physical, emotional, social, and school functioning; individualized rehabilitation goal achievement evaluated using Goal Attainment Scaling (GAS), allowing measurement of clinically meaningful patient-specific functional improvements; objective training parameters recorded automatically by the Lokomat® system, including walking distance, average walking speed, and robotic assistance level during the first and final treatment sessions.

Functional severity at baseline will be classified using the Gross Motor Function Classification System (GMFCS).

Eligibility Criteria

Eligible participants are children and young adults aged 3-23 years with a confirmed diagnosis of cerebral palsy (ICD-10 G80), classified as GMFCS levels II-IV, who meet the technical requirements for Lokomat use, possess current orthopedic evaluation and hip radiography, have a valid medical referral for robotic gait training, and whose parents or legal guardians provide written informed consent.

Participants will be excluded if they are classified as GMFCS level I or V, receive concurrent robot-assisted gait training elsewhere during the control period, or present with contraindications to Lokomat-assisted rehabilitation, including unstable fractures, severe osteoporosis, fixed joint contractures, acute medical illness, significant skin lesions, anatomical incompatibility with the device, or any other condition compromising safe participation according to the manufacturer's safety recommendations.

Inclusion criteria

• 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

Exclusion criteria

• 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.