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. 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.

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.