- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03856905
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.
Study Overview
Status
Conditions
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Giza, Egypt, 12613
- Faculty of Physical Therapy - Cairo University
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Physical therapy group
The children in this group will receive the conventional physical therapy program (CPTP).
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, neuro-developmental techniques, and gait training.
The total program will be conducted for 1 h, three sessions/week for 12 weeks.
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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.
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Experimental: Extra-corporeal shock wave therapy group
The children in this group only will receive the extra-corporeal shock wave therapy (ESWT).
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) will be used.
The energy applied will be 0.030 mJ/mm2.
The frequency will be 5 Hz, with a pressure of 1.5 bars, burst mode, one session/week for 12 weeks.
The treatment is painless and does not require any kind of anesthesia or the use of analgesic drugs
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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.
|
Experimental: Functional electrical stimulation group
The children in this group will receive the functional electrical stimulation (FES). The FES will be applied by using the WalkAide system (Innovative Neurotronics, Austin, TX, USA). 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. |
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 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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Spasticity (assessing change between baseline and after treatment)
Time Frame: This outcome will be measured for each child before the beginning of treatment program and immediately after 12 weeks of the treatment program
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Name of the scale: The Modified Ashworth Scale. It will be used to measure spasticity of the ankle plantar flexors. It is a simple measure of spasticity giving grades (0, 1, 1+, 2, 3, 4) 0: No increase in muscle tone
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This outcome will be measured for each child before the beginning of treatment program and immediately after 12 weeks of the treatment program
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Function (assessing change between baseline and after treatment)
Time Frame: This outcome will be measured for each child before the beginning of treatment program and immediately after 12 weeks of the treatment program.
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Name of the scale: Functional Independence Measure for Children It will be used to assess the functions of children between 6 months and 12 years. The scores of the scale extends from minimum 18 (fully dependent) to maximum 126 (fully independent) The scale measures different functional activities in children and the total score will be obtained for each category by computing the mean of the obtained data. Higher scores indicate better results. |
This outcome will be measured for each child before the beginning of treatment program and immediately after 12 weeks of the treatment program.
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Cadence (assessing change between baseline and after treatment)
Time Frame: This outcome will be measured for each child before the beginning of treatment program and immediately after 12 weeks of the treatment program.
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Cadence will be evaluated by using the 3-dimensional motion analysis system (Qualisys; Qualisys Inc, Goeteborg, Sweden). The unit of measure of cadence: steps/minute |
This outcome will be measured for each child before the beginning of treatment program and immediately after 12 weeks of the treatment program.
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Stride length (assessing change between baseline and after treatment)
Time Frame: This outcome will be measured for each child before the beginning of treatment program and immediately after 12 weeks of the treatment program.
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Stride length will be evaluated by using the 3-dimensional motion analysis system (Qualisys; Qualisys Inc, Goeteborg, Sweden). The unit of measure of Stride length: meter |
This outcome will be measured for each child before the beginning of treatment program and immediately after 12 weeks of the treatment program.
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Velocity (assessing change between baseline and after treatment)
Time Frame: This outcome will be measured for each child before the beginning of treatment program and immediately after 12 weeks of the treatment program.
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Velocity will be evaluated by using the 3-dimensional motion analysis system (Qualisys; Qualisys Inc, Goeteborg, Sweden). The unit of measure of velocity: meter/sec |
This outcome will be measured for each child before the beginning of treatment program and immediately after 12 weeks of the treatment program.
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Ankle dorsiflexion angle (assessing change between baseline and after treatment)
Time Frame: This outcome will be measured for each child before the beginning of treatment program and immediately after 12 weeks of the treatment program.
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Ankle dorsiflexion angle will be evaluated by using the 3-dimensional motion analysis system (Qualisys; Qualisys Inc, Goeteborg, Sweden). The unit of measure of Ankle dorsiflexion angle: degrees |
This outcome will be measured for each child before the beginning of treatment program and immediately after 12 weeks of the treatment program.
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- NU/MID/16/025
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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