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Evaluation of Outcomes of Robotics Rehabilitation in Cerebral Palsy

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06594653
Acronym
LK
Enrollment
59
Registered
2024-09-19
Start date
2024-05-15
Completion date
2025-05-15
Last updated
2026-04-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cerebral Palsy, Gait Disorders, Neurologic

Keywords

Robotic Rehabilitation, Gait

Brief summary

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.

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.

Interventions

OTHERpre treatment assesment

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.

OTHERpost treatment assessment

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.

Sponsors

IRCCS Eugenio Medea
Lead SponsorOTHER

Study design

Observational model
OTHER
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
5 Years to 18 Years

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.

Design outcomes

Primary

MeasureTime frameDescription
Effectiveness of the rehabilitation program in terms of gait speedThrough study completion, an average of 1 yearStarting 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.
Effectiveness of the rehabilitation program in terms of cadenceThrough study completion, an average of 1 yearStarting 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.
Effectiveness of the rehabilitation program in terms of stride lengthThrough study completion, an average of 1 yearStarting 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.
Effectiveness of the rehabilitation program in terms of step widthThrough study completion, an average of 1 yearStarting 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.
Effectiveness of the rehabilitation program in terms of gait phaseThrough study completion, an average of 1 yearStarting 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.
Effectiveness of the rehabilitation program in terms of lower limbs ROMThrough study completion, an average of 1 yearStarting 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.
Effectiveness of the rehabilitation program in terms of summary gait parameters GDIThrough study completion, an average of 1 yearStarting 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.
Effectiveness of the rehabilitation program in terms of summary gait parameters GPSThrough study completion, an average of 1 yearStarting 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

MeasureTime frameDescription
Treatment effect based on the level of impairment about walk fatiqueThrough study completion, an average of 1 yearFor 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.
Treatment effect based on the level of impairment about gross motor abilityThrough study completion, an average of 1 yearFor 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.
Treatment effect based on the level of impairment about functional activityThrough study completion, an average of 1 yearFor 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.

Countries

Italy

Contacts

PRINCIPAL_INVESTIGATORLuigi Piccinini

Istituto di Ricovero e Cura a Carattere Scientifico Eugenio Medea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 14, 2026