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Completed

NCT Number: NCT06594653

Evaluation of Outcomes of Robotics Rehabilitation in Cerebral Palsy

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.

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Key information

Conditions

Cerebral Palsy Brain Damage, Chronic Brain Diseases Central Nervous System Diseases Gait Disorders, Neurologic Nervous System Diseases Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

5 year–18 year

Sex eligibility

All sexes

Study type

Observational

Primary location

IRCCS E. Medea

Bosisio Parini, Italy, 22037

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

pre treatment assesment

Other

All measurements will be obtained using an optoelectronic multicamera system for human motion analysis (with eight high-resolution cameras with infrared light and a sampling frequency of 60 Hz. The experimental protocol requires the positioning of markers (plastic spheres covered by reflecting film, 10 mm in diameter). Markers will be placed by clinical operators (physiotherapists with training in optoelectronic system for human motion analysis) after training and experience in recognition of the position of body landmarks.

post treatment assessment

Other

All measurements will be obtained using an optoelectronic multicamera system for human motion analysis (with eight high-resolution cameras with infrared light and a sampling frequency of 60 Hz. The experimental protocol requires the positioning of markers (plastic spheres covered by reflecting film, 10 mm in diameter). Markers will be placed by clinical operators (physiotherapists with training in optoelectronic system for human motion analysis) after training and experience in recognition of the position of body landmarks.

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

Sponsors and collaborators

Lead sponsor

IRCCS Eugenio Medea

Other

Registry information

Official study title

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

Acronym: LK

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Sep 19, 2024
Registry last updated
Apr 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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