Not Yet RecruitingNot Applicable

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

Hungary96 participantsStarted 2026-08-31

Plain-language 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. 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.

Who can participate

Age range

3 Years – 23 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Since this trial specifically uses the Lokomat robot-assisted device to work on standing and walking, would my child's current level of mobility and muscle control make them a good or poor fit for this type of robotic gait training?
2This trial is listed as 'not yet recruiting' — do you have any sense of when it might open, and is it worth waiting for it versus starting other therapies now that could also address gross motor function?
3Because this study is listed as Phase NA, meaning it's not a standard drug trial with established phase safety data, what do we know so far about the safety of Lokomat training in children and young adults with cerebral palsy from other research?
4The trial is focused on standing and walking outcomes — given where my child is on the gross motor function scale right now, is there a realistic chance this kind of robotic training could make a meaningful difference for them specifically?
5Are there non-robotic physical therapy or gait training options we should consider in parallel or instead, and how would participating in this trial fit alongside whatever standard care plan you'd recommend?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Standing and walking functions

Timeframe: Measurement at 0 weeks and 8 weeks

Trial details

NCT IDNCT07732205

SponsorSemmelweis University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2027-08-31

View on ClinicalTrials.gov More Cerebral Palsy trials