Shock Wave and Spastic Cerebral Palsy Equines Foot (CP)

Taibah University

Status: Unknown

Conditions: Cerebral Palsy

Treatments: Device: shock wave; Other: traditional physical therapy program

Study type: Interventional

Funder types: Other

Identifiers

NCT04835753

taibah university

Details and patient eligibility

About

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.

Full 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.

Enrollment: 34 patients

Sex: All

Ages: 7 to 9 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 1. 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

Exclusion criteria

• 1. 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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34 participants in 2 patient groups

study group

Experimental group

Description:

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.

Treatment:

Other: traditional physical therapy program

Device: shock wave

control group

Other group

Description:

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

Treatment:

Other: traditional physical therapy program