Evaluation of Outcomes of Robotics Rehabilitation in Cerebral Palsy

NCT06594653 | Completed

• 1 other identifier: ID 1123
• Study Type: observational
• Target: 59
• Locations: 1 country
• Sites: 1

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.

Conditions

Cerebral Palsy; Gait Disorders, Neurologic

Keywords

Robotic Rehabilitation; Gait

Outcome Measures

Primary Outcomes (8)

• 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.

  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

Secondary Outcomes (3)

• 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

Interventions

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.

Eligibility Criteria

• Age: 5 Years - 18 Years
• Sex: all
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Probability Sample

Study Population

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.

You may qualify if:

• diagnosis of CP;
• able to walk independently with or without assistance

You may not qualify if:

• presence of behavioral problems;
• presence of uncontrolled seizures
• presence of severe visual disturbances.

Sponsors & Collaborators

• IRCCS Eugenio Medea: lead

Study Sites (1)

IRCCS E. Medea

Bosisio Parini, Italy, 22037, Italy

Location

MeSH Terms

Conditions

Cerebral Palsy; Gait Disorders, Neurologic

Condition Hierarchy (Ancestors)

Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Luigi Piccinini

  Istituto di Ricovero e Cura a Carattere Scientifico Eugenio Medea

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 5, 2024
• First Posted: September 19, 2024
• Study Start: May 15, 2024
• Primary Completion: May 15, 2025
• Study Completion: May 15, 2025
• Last Updated: April 13, 2026

Record last verified: 2024-09

Locations

IT (1)