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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.
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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| 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. |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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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.
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| Name | Affiliation | Role |
|---|---|---|
| Luigi Piccinini | Istituto di Ricovero e Cura a Carattere Scientifico Eugenio Medea | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| IRCCS E. Medea | Bosisio Parini | Italy | 22037 | Italy |
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| ID | Term |
|---|---|
| D002547 | Cerebral Palsy |
| D020233 | Gait Disorders, Neurologic |
| ID | Term |
|---|---|
| D001925 | Brain Damage, Chronic |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| 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 |
| 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 |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |