Spastic diplegic cerebral palsy
Conditions
Interventions
Patients will be randomly assigned pre-stratified according to three stratification variables: motor impairment (diparetic or hemiparetic), GMFCS level (I, II, and III) and age (youngest: 4–9 years
oldest: 10–14 years) and subsequently randomized to one of two groups (control and experimental) using sealed envelopes. Thus, patients will be randomly divided into 4 groups: those who will receive b
Sponsors
Hospital Universitário Bettina Ferro de Souza
Hospital Universitário Bettina Ferro de Souza
Eligibility
Age
4 Years to 14 Years
Inclusion criteria
Inclusion criteria: Affected with diparetic or spastic hemiparetic cerebral palsy; age between 4 and 14 years; both genders; be able to walk independently in a closed environment (Gross Motor Function Classification System [GMFCS] from I to III; able to perform all assessment and treatment procedures in the study
Exclusion criteria
Exclusion criteria: Presence of joint blockage in the joints of the lower limbs; previous orthopedic surgery in the lower limbs up to one year prior to selection; presence of visual impairment; important cognitive alterations that prevent the accomplishment of the study protocols; abandonment of physical therapy; presence of fixed contracture in the lower limbs
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Up to 120 days, it is expected to find a reduction in lower limb spasticity verified through the reduction in the modified Ashworth scale score, with a variation of at least 20% in pre and post intervention measurements in the experimental group and that these results are superior to those found in the control group.;Up to 120 days, it is expected to find improvement in bipedal static balance using the method in static bipedal posture on top of a pressure platform, the baropodometer, with measurements of variations in the center of pressure (velocity [mm/s]; distance [mm] and ellipse area [mm2]), with variations of at least 25% in pre and post intervention measurements in the experimental group and that these results are superior to those found in the control group.;Up to 120 days, to evaluate the improvement of dynamic balance through the Timed Up and Go Test (TUG), the sit and stand test, and the 10-meter walk from the observation of a drop in the performance time, in seconds, in all tests, at least two seconds in pre and post intervention measurements in the experimental group and that these results are superior to those found in the control group.;Up to 120 days, it is estimated to find a better distribution of area and plantar pressure through evaluations using the baropodometer in the bipedal posture; with a minimum variation of 20% in the hindfoot region before and after intervention in the experimental group and that these results are superior to those found in the control group. | — |
Secondary
| Measure | Time frame |
|---|---|
| to 120 days, it is expected to find greater ranges of motion of the ankles and knees through goniometry, with a variation of at least 5 degrees in ankle dorsiflexion and 10 degrees in knee extension in pre and post intervention measurements in the experimental group and that these results are superior to those found in the control group.;Up to 120 days, it is expected to find improvement in bipedal static balance using the method in static bipedal posture with the use of a triaxial accelerometer, with measurements of the center of mass variations being verified, with variations of at least 25% in pre and post intervention measurements in the experimental group and that these results are superior to those found in the control group.;In 180 days, it is expected the maintenance of variations of all variables found up to 120 days in the experimental group. | — |
Countries
Brazil
Contacts
Public ContactDaniela Garcez
Hospital Universitário Bettina Ferro de Souza
Outcome results
None listed