Children With Cerebral Palsy Clinical Trial
Official title:
Extracorporeal Shock Wave Therapy Versus Functional Electrical Stimulation on Spasticity, Function and Gait Parameters in Hemiplegic Cerebral Palsy
Objective: The purpose of this study will compare the effects of extracorporeal shock wave
therapy (ESWT) versus functional electrical stimulation (FES) on spasticity, function and
gait parameters in hemiplegic cerebral palsy (CP).
Methods: Forty-five children with CP ranging in age from 6 to 9 years will be selected and
will participate in this study. They will be assigned randomly using opaque envelopes into
three groups (A, B and C). Group A will consist of 15 children and will receive the
conventional physical therapy program (CPTP) in addition to ankle foot orthosis (AFO). Group
B will consist of 15 children and will receive the CPTP, AFO in addition to ESWT. Group C
also will consist of 15 children and will receive the CPTP, AFO in addition to FES. The
program of treatment will be 3 days/week for 12 weeks. Assessment of spasticity by using the
modified ashworth scale (MAS), function by using the pediatric functional independence scale
and gait parameters by using the 3-dimensional gait analysis will be conducted at baseline
and after 12 weeks of the treatment program.
Forty-five children with cerebral palsy (CP) with ages ranging from 6 to 9 years will
participate in this study. They will be selected from the out-patient clinic of Obstetric and
Pediatric Hospital, Comprehensive Rehabilitation Center, King Khalid Hospital and Najran
Generalized Hospital, Najran, KSA, according to inclusive criteria including, children who
demonstrate unilateral dynamic equinus deformity, all children must be ambulant independently
and they will classified at Gross Motor Function Classification System (GMFCS) levels I or
II. They must be free from any skeletal abnormalities other than spasticity and the degree of
spasticity according to the Modified Ashworth Scale (MAS) within the range of 1+ and 2
grades. Moreover, all children must have a minimum five degrees of passive ankle dorsiflexion
with knee joint extended. Exclusion criteria including, the use of botulinum toxin injection
of the planter flexor muscles within the 4 months before the study and orthopedic surgery to
the ankle joint in the previous 6 months before or during the study.
Children will be assigned randomly using opaque envelopes into three intervention groups (A,
B and C). Group A will receive the conventional physical therapy program (CPTP) in addition
to ankle foot orthosis (AFO). Group B will receive the CPTP, AFO in addition to
Extra-corporeal shock wave therapy (ESWT), whereas group C will receive CPTP, AFO in addition
to functional electrical stimulation (FES). All groups will receive the treatment program 3
sessions/week for 12 weeks. Evaluation of spasticity by using the MAS, function by using the
pediatric functional independence scale and gait parameters by using the 3-dimensional gait
analysis will be conducted before and after 12 weeks of the treatment program.
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