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.
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
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
significant bone mineral density loss (osteopenia, osteoporosis) and increased fracture risk;
Sequential
Sessions with Lokomat robot-assisted system
DeviceDuring the intervention, participants accomplish rehabilitation sessions by using Lokomat robotic gait training system. Each participant will participate in robot-assisted rehabilitation and physiotherapy 5 times in two weeks, 20 times total during the 8 week period of rehabilitation. The robot-assisted rehabilitation session lasts approximately 60 minutes, depends on the individual needs and performance.
Control arm
Other interventionParticipants continue their usual rehabilitation without Lokomat -assisted gait training during the control period.
Standing and walking functions
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.
Lower limb muscle strength
Change in lower limb muscle strength assessed using a handheld dynamometer. Muscle strength will be measured in Newtons (N)/kilograms-force \[kgf\] during standardized maximal voluntary isometric contractions of predefined lower limb muscle groups. Three trials will be performed for each muscle group, and the highest value will be used for analysis. The primary outcome will be the change in muscle strength from baseline to the post-intervention assessment. Results will be summarized as mean ± standard deviation and compared between study groups using appropriate statistical methods.
Goal attainment
Goal Attainment Scaling (GAS) is a personalized outcome measure used in clinical and rehabilitation settings to track a patient's progress toward individualized goals. It allows patients and practitioners to collaboratively set specific targets and translate qualitative improvements into standardized numerical scores for statistical evaluation. Each goal will be rated on a 5-point scale ranging from -2 (baseline or much less than expected outcome) to +2 (much better than expected outcome), with 0 representing the expected level of achievement after the intervention. Individual goal scores will be converted into a standardized GAS T-score (mean = 50, standard deviation = 10) when appropriate. Changes in GAS scores from baseline to the post-intervention assessment will be summarized using mean ± standard deviation and compared between study groups using appropriate statistical methods.
Functional performance changes measured by walking speed
Walking speed will be assessed using the 10-Meter Walk Test (10MWT), a validated and reliable measure of gait performance. Participants will be instructed to walk at their self-selected comfortable walking speed along a standardized walkway. The time required to complete the test will be recorded in seconds, and walking speed will be calculated in meters per second (m/s). Changes in walking speed from baseline to the post-intervention assessment will be analyzed. Results will be summarized using mean and standard deviation (SD).
Changes in training parameters recorded by the Lokomat system
Objective gait training parameters will be automatically recorded by the Lokomat system during the first and last treatment sessions. Recorded parameters will include walking distance (m), average walking speed (km/h), and robotic assistance level (% body weight support and/or guidance force, depending on the Lokomat settings). Changes in these parameters from baseline to the final treatment session will be analyzed. Results will be summarized as mean ± standard deviation and compared within and between study groups using appropriate statistical methods.
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