Clinical trial NCT03856905: Extracorporeal Shock Wave Therapy Versus Functional Electrical Stimulation on Spasticity, Function and Gait Parameters in Hemiplegic Cerebral Palsy
Official title: Extracorporeal Shock Wave Therapy Versus Functional Electrical Stimulation on Spasticity, Function and Gait Parameters in Hemiplegic Cerebral Palsy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Children With Cerebral Palsy
Keywords: Cerebral palsy
Extracorporeal Shock Wave Therapy
Functional Electrical Stimulation
Function
Gait
Spasticity
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2019-02-27
Enrollment: 45
Sex: ALL
Minimum age (years): 6
Maximum age (years): 9
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* 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:

* The use of botulinum toxin injection of the planter flexor muscles within the 4 months before the study,
* Orthopedic surgery to the ankle joint in the previous 6 months before or during the study.

Primary outcomes:
measure: Spasticity (assessing change between baseline and after treatment)
timeFrame: This outcome will be measured for each child before the beginning of treatment program and immediately after 12 weeks of the treatment program
measure: Function (assessing change between baseline and after treatment)
timeFrame: This outcome will be measured for each child before the beginning of treatment program and immediately after 12 weeks of the treatment program.
measure: Cadence (assessing change between baseline and after treatment)
timeFrame: This outcome will be measured for each child before the beginning of treatment program and immediately after 12 weeks of the treatment program.
measure: Stride length (assessing change between baseline and after treatment)
timeFrame: This outcome will be measured for each child before the beginning of treatment program and immediately after 12 weeks of the treatment program.
measure: Velocity (assessing change between baseline and after treatment)
timeFrame: This outcome will be measured for each child before the beginning of treatment program and immediately after 12 weeks of the treatment program.
measure: Ankle dorsiflexion angle (assessing change between baseline and after treatment)
timeFrame: This outcome will be measured for each child before the beginning of treatment program and immediately after 12 weeks of the treatment program.
Secondary outcomes:
Other outcomes:
Locations:
city: Giza
country: Egypt
facility: Faculty of Physical Therapy - Cairo University
Study officials:
References: