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

August 26, 2026 updated by: Semmelweis University

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

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).

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
96

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Hungary
    • Pest County
      • Budapest, Pest County, Hungary, 1125
        • Semmelweis University, András Pető Rehabilitation and Health Care Department, Institutions of Conductive Pedagogical Center
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.
Device: Sessions with Lokomat robot-assisted system
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.
Active Comparator: 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.
Other: Control arm
Participants continue their usual rehabilitation without Lokomat -assisted gait training during the control period.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Standing and walking functions
Time Frame: Measurement at 0 weeks and 8 weeks
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Lower limb muscle strength
Time Frame: Measurement at 0 weeks, 8 weeks
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.
Measurement at 0 weeks, 8 weeks
Goal attainment
Time Frame: Measurement at 0 weeks and 8 weeks
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.
Measurement at 0 weeks and 8 weeks
Functional performance changes measured by walking speed
Time Frame: Measurement at 0 weeks and 8 weeks.
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).
Measurement at 0 weeks and 8 weeks.
Changes in training parameters recorded by the Lokomat system
Time Frame: Measurement at 0 weeks and 8 weeks.
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.
Measurement at 0 weeks and 8 weeks.
Health-related quality of life
Time Frame: Measurement at 0 weeks and 8 weeks.

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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Semmelweis University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 31, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 31, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 31, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 23, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 23, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 28, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 31, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 26, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • KEB/2026/096

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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