NCT04835753

Shock Wave and Spastic Cerebral Palsy Equines Foot

Effects Of Extracorporeal Shock Wave On Spastic Equines Foot In Children With Hemiplegic Cerebral Palsy

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 34 (actual)
• Sponsor: Taibah University · Academic / Other
• Sex: All
• Age: 7 Years – 9 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Cerebral Palsy

Interventions

Type	Name	Description
DEVICE	shock wave	true radial ESWT.A rESW pneumatic device (SHOCK MED, Italy) was used to provide one session per week (for a total of 12-week)
OTHER	traditional physical therapy program	lower limbs muscles stretch and strength in addition to balance and gait training

Timeline

• Start date: 2021-01-01
• Primary completion: 2021-03-30
• Completion: 2021-05-15
• First posted: 2021-04-08
• Last updated: 2021-04-08

Locations

1 site across 1 country: Saudi Arabia