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.
Descripción general del estudio
Estado
Estado
Condiciones
Condiciones
Intervención / Tratamiento
Intervención / Tratamiento
Descripción detallada
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. Participants are enrolled according to the routine admission schedule and allocated to either an intervention group or a concurrent control group.
Participants in the intervention group receive a 20-session Lokomat-assisted gait training program in addition to their usual rehabilitation. Participants in the control group continue their usual rehabilitation during the control period and subsequently receive the same Lokomat-assisted intervention after completion of the post-control assessment. Participants assigned to the final control group receive the intervention after completion of the formal study period, ensuring that all eligible participants have access to robotic gait training.
Approximately 96 participants with cerebral palsy are expected to be enrolled.
Outcome assessments are performed before and after each study period and include evaluation of standing and walking function using the GMFM-88 Dimensions D and E, lower limb muscle strength, walking speed, health-related quality of life, 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).
Tipo de estudio
Tipo de estudio
Inscripción (Estimado)
Inscripción
Fase
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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Pest County
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Budapest, Pest County, Hungría, 1125
- Semmelweis University, András Pető Rehabilitation and Health Care Department, Institutions of Conductive Pedagogical Center
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Contacto:
- Anna Burián-Fehér
- Número de teléfono: +3630+3653493
- Correo electrónico: feher.anna@semmelweis.hu
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Criterios de participación
Criterio de elegibilidad
Criterio de elegibilidad
Edades elegibles para estudiar
- Niño
- Adulto
Acepta Voluntarios Saludables
Descripción
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.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: No aleatorizado
- Modelo Intervencionista: Asignación Secuencial
- Enmascaramiento: Ninguno (etiqueta abierta)
Número de brazos
Armas e Intervenciones
Grupo de participantes/brazoGrupo de participantes/brazo |
Intervención / TratamientoIntervención / Tratamiento |
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Experimental: 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.
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During 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.
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Comparador activo: 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.
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Participants continue their usual rehabilitation without Lokomat -assisted gait training during the control period.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Standing and walking functions
Periodo de tiempo: Measurement at 0 weeks and 8 weeks
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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.
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Measurement at 0 weeks and 8 weeks
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Medidas de resultado secundarias
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Lower limb muscle strength
Periodo de tiempo: Measurement at 0 weeks, 8 weeks
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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.
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Measurement at 0 weeks, 8 weeks
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Goal attainment
Periodo de tiempo: Measurement at 0 weeks and 8 weeks
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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.
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Measurement at 0 weeks and 8 weeks
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Functional performance changes measured by walking speed
Periodo de tiempo: Measurement at 0 weeks and 8 weeks.
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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).
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Measurement at 0 weeks and 8 weeks.
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Changes in training parameters recorded by the Lokomat system
Periodo de tiempo: Measurement at 0 weeks and 8 weeks.
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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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Measurement at 0 weeks and 8 weeks.
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Health-related quality of life
Periodo de tiempo: Measurement at 0 weeks and 8 weeks.
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Health-related quality of life (HRQoL) will be assessed using the Pediatric Quality of Life Inventory (PedsQL™) Scales, selecting the age-appropriate version for each participant. The questionnaire will be administered at baseline and at the post-intervention assessment. For participants 2-4 years of age, the parent-proxy report will be completed by the parent or primary caregiver. For children 5-7 years of age, both the child self-report and the parent-proxy report will be obtained. Participants 8-12 years and 13-23 years will complete the age-appropriate child/adolescent self-report, while a corresponding parent-proxy report will also be collected. The PedsQL Generic Core Scales assess four domains of health-related quality of life: physical functioning, emotional functioning, social functioning, and school functioning.The total score will be analyzed as continuous variables. Results will be summarized using mean and standard deviation (SD). |
Measurement at 0 weeks and 8 weeks.
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Colaboradores e Investigadores
Patrocinador
Patrocinador
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Estimado)
Inicio del estudio
Finalización primaria (Estimado)
Finalización primaria
Finalización del estudio (Estimado)
Finalización del estudio
Fechas de registro del estudio
Enviado por primera vez
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Publicado por primera vez
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización publicada
Última actualización enviada que cumplió con los criterios de control de calidad
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
- rehabilitación
- parálisis cerebral
- terapia asistida por robot
- calidad de vida relacionada con la salud
- entrenamiento de la marcha asistido por robot
- función de caminar
- función motora gruesa
- lokomat
- educación conductiva
- pediatric neurorehabilitation
- gross motor function measure
- goal attainment scaling
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
Otros números de identificación del estudio
- KEB/2026/096
Información sobre medicamentos y dispositivos, documentos del estudio
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