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

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: Completed
• Conditions: Cerebral Palsy; Gait Disorders, Neurologic
• Intervention / Treatment: Other: pre treatment assesment; Other: post treatment assessment

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: Observational
• Enrollment (Actual): 59

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Effectiveness of the rehabilitation program in terms of gait speed	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	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	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	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	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	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	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	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

Outcome Measure	Measure Description	Time Frame
Treatment effect based on the level of impairment about walk fatique	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	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	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

• Sponsor: IRCCS Eugenio Medea
• Investigators: Principal Investigator: Luigi Piccinini, Istituto di Ricovero e Cura a Carattere Scientifico Eugenio Medea

Study record dates

Study Major Dates

• Study Start (Actual): May 15, 2024
• Primary Completion (Actual): May 15, 2025
• Study Completion (Actual): May 15, 2025

Study Registration Dates

• First Submitted: August 5, 2024
• First Submitted That Met QC Criteria: September 10, 2024
• First Posted (Actual): September 19, 2024

Study Record Updates

• Last Update Posted (Actual): April 13, 2026
• Last Update Submitted That Met QC Criteria: April 9, 2026
• Last Verified: September 1, 2024

More Information

Terms related to this study

• Keywords: Gait; Robotic Rehabilitation
• Additional Relevant MeSH Terms: Neurologic Manifestations; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Brain Damage, Chronic; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Cerebral Palsy; Gait Disorders, Neurologic
• Other Study ID 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