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Clinical Trials/NCT06594653
NCT06594653
Completed
N/A

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

IRCCS Eugenio Medea2 sites in 1 country59 target enrollmentMay 15, 2024

Overview

Phase
N/A
Intervention
Not specified
Conditions
Cerebral Palsy
Sponsor
IRCCS Eugenio Medea
Enrollment
59
Locations
2
Primary Endpoint
Effectiveness of the rehabilitation program in terms of gait speed
Status
Completed
Last Updated
19 days ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
May 15, 2024
End Date
May 15, 2025
Last Updated
19 days ago
Study Type
Observational
Sex
All

Investigators

Sponsor
IRCCS Eugenio Medea
Responsible Party
Sponsor

Eligibility Criteria

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.

Outcomes

Primary Outcomes

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.

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.

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.

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.

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.

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.

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.

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

  • Treatment effect based on the level of impairment about walk fatique(Through study completion, an average of 1 year)
  • Treatment effect based on the level of impairment about gross motor ability(Through study completion, an average of 1 year)
  • Treatment effect based on the level of impairment about functional activity(Through study completion, an average of 1 year)

Study Sites (2)

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