The Effectiveness of Robotic Gait Training in Children With Neurological Impairment

Study 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).

Official Title
-----------------
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

Conditions
-----------------
Acquired Brain Injury, Cerebral Palsy

Intervention / Treatment
-----------------
* Device: Robotic Assisted Gait Training (Lokomat)
* Procedure: Physiotherapy


Participation Criteria
=================
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 cardiovascular instability acute or progressive neurological disorders aggressive or self-harming behavior.

Ages Eligible for Study
-----------------
Minimum Age: 4 Years
Maximum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Children with neurological impairment<br> | Device: Robotic Assisted Gait Training (Lokomat)<br>* The RAGT treatment consisted of sessions lasting 45 minutes each performed with the commercially available Lokomat device. The same exercises were offered to the children with preset duration, speed, and difficulty. For all patients, the initial body-weight support was set at 50%, and was then gradually decreased according to the individual functional capacity. The guidance force was initially set to 100% for all children, and then gradually reduced.<br>* Other names: RAGT;Procedure: Physiotherapy<br>* The physiotherapic sessions aimed at strengthening the gluteus and quadriceps muscles, stretching the hip flexor and hamstrings muscles, increasing static balance, increasing dynamic balance, increasing functional abilities, improving ground gait and climbing stairs.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in 6minWT distance walked | 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. | After four weeks of treatment | 
| change in GMFM-88: total score and Dimensions | 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. | After four weeks of treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change in spatiotemporal gait parameters | Data obtained using 3D gait analysis | After four weeks of treatment | 
| change in kinematic gait parameters | Data obtained using 3D gait analysis | After four weeks of treatment | 
| change in kinetic gait parameters | Data obtained using 3D gait analysis | After four weeks of treatment | 
| change in FAQ score | The Functional Activities Questionnaire (FAQ) measures instrumental activities of daily living | After four weeks of treatment | 
| Lokomat therapy duration | Total duration of therapy sessions (hours and minutes) | After four weeks of treatment | 
| Lokomat therapy total distance walked | Total distance walked during sessions (in meters) | After four weeks of treatment | 
| Lokomat therapy total time walked | Total time walked during sessions | After four weeks of treatment | 
| Lokomat stiffness values (LStiff) | Joint stiffness measured by the Lokomat device (in Newton/meters) | After four weeks of treatment | 
| Lokomat force values (LForce) | Joint force measured by the Lokomat device (in Newton) | After four weeks of treatment | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Robotic-Assisted Gait Training, Gait Rehabilitation