Investigating the Effectiveness of Robotic-Assisted Gait Training (RAGT) in the Rehabilitation of Children With Neurological Impairment Due to Acquired Brain Injury or Cerebral Palsy
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Acquired Brain Injury
- Sponsor
- IRCCS Eugenio Medea
- Enrollment
- 200
- Locations
- 1
- Primary Endpoint
- change in GMFM-88: total score and Dimensions
- Status
- Completed
- Last Updated
- 6 years ago
Overview
Brief Summary
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).
Investigators
Eligibility Criteria
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
Outcomes
Primary Outcomes
change in GMFM-88: total score and Dimensions
Time Frame: After four weeks of treatment
The Gross Motor Function Measure (GMFM) measures the child's overall functional abilities, and is divided into the following sections: (A) lying and rolling, (B) sitting, (C) crawling and kneeling, (D) standing, and (E) walking, running, and jumping.
Change in 6minWT distance walked
Time Frame: After four weeks of treatment
The 6-minute walk test (6minWT) was used to assess endurance during self-paced, submaximal walk by measuring the distance walked within 6 minutes along a standardized route through the hospital corridors.
Secondary Outcomes
- change in kinematic gait parameters(After four weeks of treatment)
- change in FAQ score(After four weeks of treatment)
- Lokomat therapy total distance walked(After four weeks of treatment)
- Lokomat therapy total time walked(After four weeks of treatment)
- Lokomat therapy duration(After four weeks of treatment)
- Lokomat force values (LForce)(After four weeks of treatment)
- Lokomat stiffness values (LStiff)(After four weeks of treatment)
- change in spatiotemporal gait parameters(After four weeks of treatment)
- change in kinetic gait parameters(After four weeks of treatment)