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

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. Robot-assisted gait training has become an increasingly important component of pediatric neurorehabilitation by enabling intensive, task-specific, repetitive, and standardized movement practice, which may facilitate motor learning and neuroplasticity. The Lokomat® system is a robotic gait orthosis combined with body-weight support and treadmill training that allows individualized adjustment of gait speed, body-weight support, and robotic assistance according to each participant's functional abilities. Previous studies have demonstrated improvements in walking ability, gait speed, endurance, gross motor function, and lower limb function following Lokomat-assisted gait training in children with cerebral palsy. However, considerable heterogeneity exists regarding treatment frequency, intensity, and duration, and the optimal training protocol remains uncertain. The primary objective is to determine 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 are to evaluate changes in 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. Outcome assessments are performed before and after each study period and include gross motor function (GMFM-88 Dimensions D and E), lower limb muscle strength measured by handheld dynamometry, the 10-Meter Walk Test, health-related quality of life (PedsQL), Goal Attainment Scaling (GAS), and objective gait training parameters recorded by the Lokomat® system. Functional severity is classified using the Gross Motor Function Classification System (GMFCS).

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.