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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Children with neurological impairment |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Robotic Assisted Gait Training (Lokomat) | Device | 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. |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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Neurophysiatric care unit
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| Name | Affiliation | Role |
|---|---|---|
| Emilia Biffi, PhD | Scientific Institute IRCCS "E. Medea" | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Scientific Institute IRCCS E. Medea | Bosisio Parini | Lecco | 23842 | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31562873 | Derived | 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. |
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| ID | Term |
|---|---|
| D001930 | Brain Injuries |
| D002547 | Cerebral Palsy |
| ID | Term |
|---|---|
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D006259 | Craniocerebral Trauma |
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| ID | Term |
|---|---|
| D026741 | Physical Therapy Modalities |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
| D012046 | Rehabilitation |
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| Physiotherapy | Procedure | 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. |
|
| 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 |
| D020196 | Trauma, Nervous System |
| D014947 | Wounds and Injuries |
| D001925 | Brain Damage, Chronic |