Clinical trial NCT03828110: The Effectiveness of Robotic Gait Training in Children With Neurological Impairment
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Acquired Brain Injury
Cerebral Palsy
Keywords: Robotic-Assisted Gait Training
Gait Rehabilitation
Lead sponsor: IRCCS Eugenio Medea
Sponsor class: OTHER
First posted: 2019-02-04
Enrollment: 200
Sex: ALL
Minimum age (years): 4
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Neurophysiatric care unit

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).


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.

Primary outcomes:
measure: Change in 6minWT distance walked
timeFrame: After four weeks of treatment
measure: change in GMFM-88: total score and Dimensions
timeFrame: After four weeks of treatment
Secondary outcomes:
measure: change in spatiotemporal gait parameters
timeFrame: After four weeks of treatment
measure: change in kinematic gait parameters
timeFrame: After four weeks of treatment
measure: change in kinetic gait parameters
timeFrame: After four weeks of treatment
measure: change in FAQ score
timeFrame: After four weeks of treatment
measure: Lokomat therapy duration
timeFrame: After four weeks of treatment
measure: Lokomat therapy total distance walked
timeFrame: After four weeks of treatment
measure: Lokomat therapy total time walked
timeFrame: After four weeks of treatment
measure: Lokomat stiffness values (LStiff)
timeFrame: After four weeks of treatment
measure: Lokomat force values (LForce)
timeFrame: After four weeks of treatment
Other outcomes:
Locations:
city: Bosisio Parini
country: Italy
facility: Scientific Institute IRCCS E. Medea
state: Lecco
Study officials:
affiliation: Scientific Institute IRCCS "E. Medea"
name: Emilia Biffi, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Beretta E, Storm FA, Strazzer S, Frascarelli F, Petrarca M, Colazza A, Cordone G, Biffi E, Morganti R, Maghini C, Piccinini L, Reni G, Castelli E. Effect of Robot-Assisted Gait Training in a Large Population of Children With Motor Impairment Due to Cerebral Palsy or Acquired Brain Injury. Arch Phys Med Rehabil. 2020 Jan;101(1):106-112. doi: 10.1016/j.apmr.2019.08.479. Epub 2019 Sep 25.