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

NCT07732205 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 96

Last updated 2026-08-04

No results posted yet for this study

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.

Conditions

  • Cerebral Palsy

Interventions

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.

OTHER

Control arm

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

Sponsors & Collaborators

  • Semmelweis University

    lead OTHER

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
3 Years
Max Age
23 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-08-31
Primary Completion
2027-08-31
Completion
2027-08-31

Countries

  • Hungary

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07732205 on ClinicalTrials.gov