Shock Wave and Spastic Cerebral Palsy Equines Foot
- Conditions
- Cerebral Palsy
- Interventions
- Device: shock waveOther: traditional physical therapy program
- Registration Number
- NCT04835753
- Lead Sponsor
- Taibah University
- Brief Summary
A double-blind randomized controlled study was carried out on 34 children (19 boys and 15 girls) in the age ranged from 7 to 9 years old with spastic hemiplegia were randomly allocated to one of two groups: control or study group. The two groups received traditional therapeutic exercises for 12 weeks. Additionally, study group received rESW (one session/week) on gastrocnemius and soleus muscles (1500 shots/muscle, frequency of 4Hz, energy of 0.030 mJ/mm2). All children were evaluated at baseline, and after 12 weeks by Modified Ashworth Scale, Biodex system 4 isokinetic dynamometer, Gross Motor Function Measure (GMFM-88), dimensions "D" standing and "E" walking, Trost Selective Motor Control Test, and Single Leg Standing Test.
- Detailed Description
Both groups underwent conventional physical therapy program which included muscle stretching, strengthening exercises, neurodevelopmental techniques, proprioceptive training, and balance and gait training for three months (3 days/week ,1 hour/day).
Study group Subjects in this group received the traditional physical therapy treatment plus true radial ESWT.A rESW pneumatic device (SHOCK MED, Italy) was used to provide one session per week (for a total of 12-week) of shock wave intervention. The pressure pulses were focused on the muscle belly of the planter flexor hypertonic muscles. Standard ultrasonic gel was used as a contact medium. A total of 1500 shots with a pressure of 1.5 bar and an energy flux density (EFD) of 0.030 mJ/mm2 were applied with the repetition frequency of shock wave irradiation of 4 pulses per second (Hz). The rESW session lasted about 6 minutes and was painless; thus, local anesthesia was not required.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 34
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- children who could walk independently or with assistive devices ,2) children with motor dysfunction graded as a 1 or 2 on the Gross Motor Function Classification System (GMFCS), 3) children scoring 1or1+ on the Modified Ashworth Scale (MAS), 4) Dynamic ankle contracture which was confirmed if ankle equinus was observed during ambulation and passive dorsiflexion of the ankle could be accomplished beyond the neutral position with knee extended
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- children older than 9 years or younger than 7 years, 2) previous botulinum toxin type A injection in the gastrocnemius muscle or serial casting of the ankle within 6 months prior to enrollment, 3) fixed ankle contracture, and 4) surgery of the lower limbs in the past 12 months.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description study group traditional physical therapy program received the traditional physical therapy program as muscle stretching and strengthening and neurodevelopmental techniques, proprioceptive training, and balance and gait training plus shock wave on the muscle belly of the planter flexor hypertonic muscles. control group traditional physical therapy program received the traditional physical therapy program as muscle stretching and strengthening and neurodevelopmental techniques, proprioceptive training, and balance and gait training .these traditional therapy had been approved by previous studies its effectiveness in management cerebral palsy child study group shock wave received the traditional physical therapy program as muscle stretching and strengthening and neurodevelopmental techniques, proprioceptive training, and balance and gait training plus shock wave on the muscle belly of the planter flexor hypertonic muscles.
- Primary Outcome Measures
Name Time Method Biodex system 12 weeks The Biodex system 4 (Biodex Medical, Shirley, NY, USA) was used for the quantitative biomechanical assessment of the spasticity of the affected side ankle plantar flexor muscle
The Trost Selective Motor Control test (TSMC) 12 weeks The TSMC test was used to assess ability of the child to perform isolated movement of the ankle.
The modified Ashworth scale 12 weeks The modified Ashworth scale, which is a six-point ordinal scale for grading (0, 1, 1+, 2, 3, and 4) was applied for clinical assessment of spasticity of ankle plantar flexors.
Single Leg Standing Test (SLS) 12 weeks The SLS is a simple and effective test to assess static balance. It is conducted by measuring the time that a child can maintain balance by lifting the foot according to the signal "Start." The average of three measures was used.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Taibah University
🇸🇦Al Madīnah, Saudi Arabia