An interventional study of shock wave and traditional physical therapy program in Cerebral Palsy, sponsored by Taibah University. Status unknown at 1 site in Saudi Arabia. Open to participants aged 7 Years to 9 Years. Per ClinicalTrials.gov, last updated 2021-04-08.
Sponsored by Taibah University · Not applicable, Interventional, and Treatment
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.
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.
750 studies on the registry are indexed under Paralysis; 133 are open to participants now.
This study's enrollment of 34 is above the median of 30 across 537 interventional studies indexed under Paralysis.
Browse Paralysis studies →Taibah University is the lead sponsor of 18 studies on the registry; none are open to participants now.
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Exclusion Criteria:
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.
Device: shock wave · Other: 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
Other: traditional physical therapy program
true radial ESWT.A rESW pneumatic device (SHOCK MED, Italy) was used to provide one session per week (for a total of 12-week)
lower limbs muscles stretch and strength in addition to balance and gait training
Biodex system
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
Time frame: 12 weeks
The modified Ashworth scale
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.
Time frame: 12 weeks
Single Leg Standing Test (SLS)
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.
Time frame: 12 weeks
The Trost Selective Motor Control test (TSMC)
The TSMC test was used to assess ability of the child to perform isolated movement of the ankle.
Time frame: 12 weeks
This study is status unknown, as verified in Apr 2021. You cannot join it, but the record below documents what was studied.
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Taibah University