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Cerebral PalsyNCT07732205

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

A study testing Sessions with Lokomat robot-assisted system in people with Cerebral Palsy, run by Semmelweis University at 1 site in Hungary.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 3 to 23 years
Conditions the study is for
Cerebral Palsy
What is being tested?
Sessions with Lokomat robot-assisted system
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
96 participants
Where
1 siteHungary
Study dates
31 Aug 2026to 31 Aug 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 3 to 23 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

Who may be able to join

  • 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

Who cannot join

  • 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;
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  • 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.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Hungary1 site
  • Semmelweis University, András Pető Rehabilitation and Health Care Department, Institutions of Conductive Pedagogical Center

    Budapest, Pest County, 1125

    Anna Burián-Fehér, +3630+3653493, feher.anna@semmelweis.hu

Other trials in Hungary

About this study

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.

Read more

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.

Read the 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).

Conditions
Cerebral Palsy
Being tested
Sessions with Lokomat robot-assisted system, Control arm
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
Medical subject headings
Cerebral Palsy

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Sessions with Lokomat robot-assisted systemDevice

    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.

  • Control armOther

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

Study groups in NCT07732205
Study groupRoleWhat they receive
Intervention ArmExperimentalIn 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.
Receives: Device: Sessions with Lokomat robot-assisted system
Control ArmActive comparatorIn 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.
Receives: Other: Control arm

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Measurement at 0 weeks and 8 weeks

Secondary outcomes (5)
  1. 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.

    Measured: Measurement at 0 weeks, 8 weeks

  2. 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.

    Measured: Measurement at 0 weeks and 8 weeks

  3. 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).

    Measured: Measurement at 0 weeks and 8 weeks.

  4. 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.

    Measured: Measurement at 0 weeks and 8 weeks.

  5. Health-related quality of life

    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).

    Measured: Measurement at 0 weeks and 8 weeks.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Jul 2026
  2. Study start31 Aug 2026 (estimated)
  3. Primary completion31 Aug 2027 (estimated)
  4. Study completion31 Aug 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Sequential
Model description
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.
Masking
None (open label)
Enrolment
96 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07732205
Sponsor's protocol ID
KEB/2026/096
Status last verified
Jul 2026
First submitted
23 Jul 2026
Last updated
31 Aug 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing Sessions with Lokomat robot-assisted system in people with Cerebral Palsy, run by Semmelweis University at 1 site in Hungary.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 31 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Hungary. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Standing and walking functions (time frame: Measurement at 0 weeks and 8 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Aug 2026.

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