Acquired Brain Injury, Cerebral Palsy
Conditions
Keywords
Robotic-Assisted Gait Training, Gait Rehabilitation
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).
Interventions
DEVICERobotic Assisted Gait Training (Lokomat)
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.
PROCEDUREPhysiotherapy
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.
Sponsors
IRCCS Eugenio Medea
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
4 Years to 18 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in 6minWT distance walked | 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. |
| change in GMFM-88: total score and Dimensions | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| change in kinetic gait parameters | After four weeks of treatment | Data obtained using 3D gait analysis |
| change in FAQ score | After four weeks of treatment | The Functional Activities Questionnaire (FAQ) measures instrumental activities of daily living |
| Lokomat therapy duration | After four weeks of treatment | Total duration of therapy sessions (hours and minutes) |
| change in spatiotemporal gait parameters | After four weeks of treatment | Data obtained using 3D gait analysis |
| Lokomat therapy total time walked | After four weeks of treatment | Total time walked during sessions |
| Lokomat stiffness values (LStiff) | After four weeks of treatment | Joint stiffness measured by the Lokomat device (in Newton/meters) |
| Lokomat force values (LForce) | After four weeks of treatment | Joint force measured by the Lokomat device (in Newton) |
| Lokomat therapy total distance walked | After four weeks of treatment | Total distance walked during sessions (in meters) |
| change in kinematic gait parameters | After four weeks of treatment | Data obtained using 3D gait analysis |
Countries
Italy
Outcome results
None listed