Extracorporeal Shock Wave Therapy Versus Functional Electrical Stimulation on Spasticity, Function and Gait Parameters in Hemiplegic Cerebral Palsy
Condition: Children With Cerebral Palsy
MeSH terms: Muscle Spasticity; Paralysis; Cerebral Palsy
Study type: Interventional

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.
    

Intervention name(s): Physical therapy program; Extracorporeal shock wave therapy; Functional electrical stimulation
Intervention type(s): Other; Device; Device
Intervention description(s): It will consist of gentle stretching exercises for spastic muscles, facilitation of muscle contraction for the anti-spastic muscles, proprioceptive training, balance and postural control exercises, neurodevelopmental techniques, and gait training.; It is an electromagnetic coil lithotripter (Modulith SLK; Storz Medical AG, Tagerwillen, Switzerland) provided with in-line ultrasound, radiographic, and computerized aiming (Lithotrack system; Storz Medical AG). The energy applied will be 0.030 mJ/mm2. The frequency will be 5 Hz, with a pressure of 1.5 bars, burst mode.; It is a highly advanced medical device that consists of a battery-operated, single-channel electrical stimulator, two electrodes, and electrode leads with a cuff holds the system in place. The stimulation parameters will include pulse frequency (16-33 pulses per second), pulse width (25-300 µs) to produce a desired movement as close to normal as possible at the ankle during gait.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Cerebral palsy; Extracorporeal Shock Wave Therapy; Functional Electrical Stimulation; Function; Gait; Spasticity