Evaluation of Outcomes of Robotics Rehabilitation in Cerebral Palsy (LK)

April 9, 2026 updated by: IRCCS Eugenio Medea

Evaluation of Outcomes Related to Walking in a Rehabilitation Program Supported by Robotics (Lokomat) in Children Suffering From Congenital and Acquired Brain Injuries

The use of robotic devices in rehabilitation programs can improve walking patterns by reorganizing joint kinematics. This study aims to quantify the effects of a rehabilitation program supported by the Lokomat (Hocoma) robotic device on walking in children and young people with movement disorders, considering different levels of impairment.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

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

Cerebral Palsy is one of the most common neuromotor disorders in pediatric age, characterized by permanent movement and posture impairments, often affecting walking. In recent decades, advancements in robotics have revolutionized rehabilitation. Studies have shown that combining conventional physiotherapy with robotic rehabilitation tools offers greater benefits in patient recovery. At the IRCCS Eugenio Medea, a robotic rehabilitation program using the Lokomat (Hocoma) has been implemented for several years to improve walking in children and young people with walking disorders. The investigators hypothesize that robotic devices can enhance walking ability (e.g., speed, stride length) and reorganize joint kinematics. This study aims to quantify the effects of this treatment based on the level of impairment.

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.
Observational

Enrollment (Actual)

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.
59

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

  • Italy
    • Italy
      • Bosisio Parini, Italy, Italy, 22037
        • IRCCS E. Medea

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

N/A

Sampling Method

Probability Sample

Study Population

The subjects enrolled in the present study are patients diagnosed with infantile cerebral palsy, able to walk independently with or without assistance. The subjects enrolled are patients who have been regularly hospitalized at the IRCCS Medea to carry out a rehabilitation program with the aid of Lokomat. Patients with behavioral problems, uncontrolled seizures, severe visual disturbances, multiple muscle-tendon retraction pattern, painful symptoms upon mobilization of the lower limbs are excluded.

Description

Inclusion Criteria:

  • diagnosis of CP;
  • able to walk independently with or without assistance

Exclusion Criteria:

  • presence of behavioral problems;
  • presence of uncontrolled seizures
  • presence of severe visual disturbances.

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

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
Effectiveness of the rehabilitation program in terms of gait speed
Time Frame: Through study completion, an average of 1 year
Starting from the data collected through Gait Analysis for each subject during the pre-treatment and post-treatment sessions, the walking speed [m\s] will be calculated. Moreover, the pre- and post-treatment results will be compared for each subject.
Through study completion, an average of 1 year
Effectiveness of the rehabilitation program in terms of cadence
Time Frame: Through study completion, an average of 1 year
Starting from the data collected through Gait Analysis for each subject during the pre-treatment and post-treatment sessions, the walking cadence [step/min] will be calculated. Moreover, the pre- and post-treatment results will be compared for each subject.
Through study completion, an average of 1 year
Effectiveness of the rehabilitation program in terms of stride length
Time Frame: Through study completion, an average of 1 year
Starting from the data collected through Gait Analysis for each subject during the pre-treatment and post-treatment sessions, the stride length [mm] will be calculated. Moreover, the pre- and post-treatment results will be compared for each subject.
Through study completion, an average of 1 year
Effectiveness of the rehabilitation program in terms of step width
Time Frame: Through study completion, an average of 1 year
Starting from the data collected through Gait Analysis for each subject during the pre-treatment and post-treatment sessions, the step width [mm] will be calculated. Moreover, the pre- and post-treatment results will be compared for each subject.
Through study completion, an average of 1 year
Effectiveness of the rehabilitation program in terms of gait phase
Time Frame: Through study completion, an average of 1 year
Starting from the data collected through Gait Analysis for each subject during the pre-treatment and post-treatment sessions, the gait phase [cycle%] will be calculated. Moreover, the pre- and post-treatment results will be compared for each subject.
Through study completion, an average of 1 year
Effectiveness of the rehabilitation program in terms of lower limbs ROM
Time Frame: Through study completion, an average of 1 year
Starting from the data collected through Gait Analysis for each subject during the pre-treatment and post-treatment sessions, the lower limbs ROM [°] will be calculated. Moreover, the pre- and post-treatment results will be compared for each subject.
Through study completion, an average of 1 year
Effectiveness of the rehabilitation program in terms of summary gait parameters GDI
Time Frame: Through study completion, an average of 1 year
Starting from the data collected through Gait Analysis for each subject during the pre-Starting from the data collected through Gait Analysis for each subject during the pre-treatment and post-treatment sessions, the summary gait parameter Gait Deviation Index (GDI) will be calculated. A GDI of 100 or higher indicates the absence of gait pathology. Moreover, the pre- and post-treatment results will be compared for each subject.
Through study completion, an average of 1 year
Effectiveness of the rehabilitation program in terms of summary gait parameters GPS
Time Frame: Through study completion, an average of 1 year
Starting from the data collected through Gait Analysis for each subject during the pre-Starting from the data collected through Gait Analysis for each subject during the pre-treatment and post-treatment sessions, the summary gait parameter Gait Profile score (GPS)[°] will be calculated. A GPS of 7 or lower indicates the absence of gait pathology. Moreover, the pre- and post-treatment results will be compared for each subject.
Through study completion, an average of 1 year

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
Treatment effect based on the level of impairment about walk fatique
Time Frame: Through study completion, an average of 1 year
For each subject, we administered the 6-Minute Walking Test to define impairment levels (moderate vs. severe impairment). The improvement of each group will be evaluated.(moderate vs. severe impairment). The improvement of differn group will be evaluate.
Through study completion, an average of 1 year
Treatment effect based on the level of impairment about gross motor ability
Time Frame: Through study completion, an average of 1 year
For each subject, we administered the Gross Motor Function Classification System (GMFCS) to define impairment levels, distinguishing between moderate and severe impairments. The GMFCS consists of five levels: Level I indicates no walking impairment, while the subsequent levels indicate increasing degrees of impairment. The improvement of each group (moderate vs. severe impairment) will be evaluated.
Through study completion, an average of 1 year
Treatment effect based on the level of impairment about functional activity
Time Frame: Through study completion, an average of 1 year
For each subject, we administered the Functional Activities Questionnaire (FAQ) to define impairment levels, distinguishing between moderate and severe impairments. FAQ sum scores range from 0 to 30, with a cut-off of 9 indicating dependence in three or more activities. The improvement of each group (moderate vs. severe impairment) will be evaluated.
Through study completion, an average of 1 year

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.
IRCCS Eugenio Medea

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Luigi Piccinini, Istituto di Ricovero e Cura a Carattere Scientifico Eugenio Medea

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 (Actual)

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.
May 15, 2024

Primary Completion (Actual)

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.
May 15, 2025

Study Completion (Actual)

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.
May 15, 2025

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).
August 5, 2024

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.
September 10, 2024

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.
September 19, 2024

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.
April 13, 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.
April 9, 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.
September 1, 2024

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.
  • ID 1123

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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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