The Effectiveness of Robotic Gait Training in Children With Neurological Impairment

IRCCS Eugenio Medea

Status: Completed

Conditions: Cerebral Palsy; Acquired Brain Injury

Treatments: Device: Robotic Assisted Gait Training (Lokomat); Procedure: Physiotherapy

Study type: Observational

Funder types: Other

Identifiers

NCT03828110

GIP-454

Details and patient eligibility

About

The recovery of walking ability is one of the primary rehabilitation goals for children with neurological impairment. The aim of the study is to investigate the clinical effectiveness of rehabilitation treatments based of Robotic-Assisted Gait Training (RAGT). Additional goals of the research are to identify the specific effects of RAGT in children with different etiologies (acquired brain injury and cerebral palsy) and with different levels of function (according to the Gross Motor Function Classification System).

Enrollment: 200 patients

Sex: All

Ages: 4 to 18 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Diagnosis of acquired brain injury in pediatric age and adolescence (4 to 18 years) or cerebral palsy;
• Femur length of at least 23 cm;
• Patients able to signal pain, fear or discomfort reliably and to follow simple instructions.

Exclusion criteria

• injection of botulinum toxin during the 6 months prior to the enrollment;
• oral medications reducing muscle tone;
• previous orthopedic surgery;
• severe lower-extremity contractures;
• fractures or osseous instabilities;
• osteoporosis;
• contraindication of full body load due to previous surgeries;
• severe retarded bone growth;
• unhealed skin lesions in the lower-extremities;
• thromboembolic diseases
• cardiovascular instability
• acute or progressive neurological disorders
• aggressive or self-harming behavior.

Trial design

200 participants in 1 patient group

Children with neurological impairment

Treatment:

Device: Robotic Assisted Gait Training (Lokomat)

Procedure: Physiotherapy