Evaluation of Outcomes of Robotics Rehabilitation in Cerebral Palsy
- Conditions
- Cerebral PalsyGait Disorders, Neurologic
- Registration Number
- NCT06594653
- Lead Sponsor
- IRCCS Eugenio Medea
- 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.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 59
- diagnosis of CP;
- able to walk independently with or without assistance
- presence of behavioral problems;
- presence of uncontrolled seizures
- presence of severe visual disturbances.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Effectiveness of the rehabilitation program in terms of gait speed 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.
Effectiveness of the rehabilitation program in terms of cadence 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.
Effectiveness of the rehabilitation program in terms of stride length 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.
Effectiveness of the rehabilitation program in terms of step width 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.
Effectiveness of the rehabilitation program in terms of gait phase 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.
Effectiveness of the rehabilitation program in terms of lower limbs ROM 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.
Effectiveness of the rehabilitation program in terms of summary gait parameters GDI 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.
Effectiveness of the rehabilitation program in terms of summary gait parameters GPS 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 Outcome Measures
Name Time Method Treatment effect based on the level of impairment about walk fatique 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.
Treatment effect based on the level of impairment about gross motor ability 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.
Treatment effect based on the level of impairment about functional activity 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.
Trial Locations
- Locations (1)
IRCCS E. Medea
🇮🇹Bosisio Parini, Italy