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

NCT07732205 | Not Yet Recruiting

• 1 other identifier: KEB/2026/096
• Study Type: interventional
• Target: 96
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

Cerebral Palsy

Keywords

rehabilitation; cerebral palsy; robot-assisted therapy; conductive education; lokomat; robot-assisted gait training; pediatric neurorehabilitation; gross motor function; walking function; health-related quality of life; gross motor function measure; goal attainment scaling

Outcome Measures

Primary Outcomes (1)

• 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.

  Measurement at 0 weeks and 8 weeks

Secondary Outcomes (5)

• Lower limb muscle strength

  Measurement at 0 weeks, 8 weeks

• Goal attainment

  Measurement at 0 weeks and 8 weeks

• Functional performance changes measured by walking speed

  Measurement at 0 weeks and 8 weeks.

• Changes in training parameters recorded by the Lokomat system

  Measurement at 0 weeks and 8 weeks.

• Health-related quality of life

  Measurement at 0 weeks and 8 weeks.

Study Arms (2)

Intervention Arm

EXPERIMENTAL

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.

Device: Sessions with Lokomat robot-assisted system

Control Arm

ACTIVE COMPARATOR

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.

Other: Control arm

Interventions

Sessions with Lokomat robot-assisted system DEVICE

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.

Intervention Arm

Control arm OTHER

Participants continue their usual rehabilitation without Lokomat -assisted gait training during the control period.

Control Arm

Eligibility Criteria

• Age: 3 Years - 23 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Semmelweis University: lead

Study Sites (1)

Semmelweis University, András Pető Rehabilitation and Health Care Department, Institutions of Conductive Pedagogical Center

Budapest, Pest County, 1125, Hungary

Location

MeSH Terms

Conditions

Cerebral Palsy

Condition Hierarchy (Ancestors)

Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This single-center, controlled, stepped delayed-intervention (wait-list control), quasi-experimental study is conducted over three consecutive study periods. Participants are enrolled in sequential groups according to the routine admission schedule; therefore, allocation is not randomized. During each study period, one group receives 20 sessions of Lokomat®-assisted gait training for approximately 60 minutes and 60 minutes long physiotherapy session based on rehabilitation goals over approximately 8 weeks in addition to usual rehabilitation, while a concurrent control group receives usual rehabilitation only. Following completion of the control period, control participants recieve the same 20-session intervention during the subsequent study period. Participants assigned to the final control group receive the intervention after completion of all study assessments. Outcomes are assessed at baseline and after each study period for both groups.

Study Record Dates

• First Submitted: July 23, 2026
• First Posted: July 28, 2026
• Study Start (Estimated): August 31, 2026
• Primary Completion (Estimated): August 31, 2027
• Study Completion (Estimated): August 31, 2027
• Last Updated: July 28, 2026

Record last verified: 2026-07

Locations

HU (1)