Clinical trial NCT06594653: Evaluation of Outcomes of Robotics Rehabilitation in Cerebral Palsy
Official title: Evaluation of Outcomes Related to Walking in a Rehabilitation Program Supported by Robotics (Lokomat) in Children Suffering from Congenital and Acquired Brain Injuries
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Cerebral Palsy
Gait Disorders, Neurologic
Keywords: Robotic Rehabilitation
Gait
Lead sponsor: IRCCS Eugenio Medea
Sponsor class: OTHER
First posted: 2024-09-19
Enrollment: 59
Sex: ALL
Minimum age (years): 5
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: RETROSPECTIVE
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.

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.

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.

Primary outcomes:
measure: Effectiveness of the rehabilitation program in terms of gait speed
timeFrame: Through study completion, an average of 1 year
measure: Effectiveness of the rehabilitation program in terms of cadence
timeFrame: Through study completion, an average of 1 year
measure: Effectiveness of the rehabilitation program in terms of stride length
timeFrame: Through study completion, an average of 1 year
measure: Effectiveness of the rehabilitation program in terms of step width
timeFrame: Through study completion, an average of 1 year
measure: Effectiveness of the rehabilitation program in terms of gait phase
timeFrame: Through study completion, an average of 1 year
measure: Effectiveness of the rehabilitation program in terms of lower limbs ROM
timeFrame: Through study completion, an average of 1 year
measure: Effectiveness of the rehabilitation program in terms of summary gait parameters GDI
timeFrame: Through study completion, an average of 1 year
measure: Effectiveness of the rehabilitation program in terms of summary gait parameters GPS
timeFrame: Through study completion, an average of 1 year
Secondary outcomes:
measure: Treatment effect based on the level of impairment about walk fatique
timeFrame: Through study completion, an average of 1 year
measure: Treatment effect based on the level of impairment about gross motor ability
timeFrame: Through study completion, an average of 1 year
measure: Treatment effect based on the level of impairment about functional activity
timeFrame: Through study completion, an average of 1 year
Other outcomes:
Locations:
city: Bosisio Parini
country: Italy
facility: IRCCS E. Medea
Study officials:
affiliation: Istituto di Ricovero e Cura a Carattere Scientifico Eugenio Medea
name: Luigi Piccinini
role: PRINCIPAL_INVESTIGATOR
References: