Shock Wave and Spastic Cerebral Palsy Equines Foot (CP)

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Cerebral Palsy
• Intervention / Treatment: Device: shock wave; Other: traditional physical therapy program

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.

• Study Type: Interventional
• Enrollment (Actual): 34
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Saudi Arabia
  • Al Madīnah, Saudi Arabia, 42353
    • Taibah University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 7 years to 9 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: study group; 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; 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
Other: control group; 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; lower limbs muscles stretch and strength in addition to balance and gait training

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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.	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.	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.	12 weeks

Collaborators and Investigators

• Sponsor: Taibah University
• Investigators: Principal Investigator: hatem emaraa, PHD, Taibah University,saudi arabia

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2021
• Primary Completion (Actual): March 30, 2021
• Study Completion (Anticipated): May 15, 2021

Study Registration Dates

• First Submitted: April 5, 2021
• First Submitted That Met QC Criteria: April 5, 2021
• First Posted (Actual): April 8, 2021

Study Record Updates

• Last Update Posted (Actual): April 8, 2021
• Last Update Submitted That Met QC Criteria: April 5, 2021
• Last Verified: April 1, 2021

More Information

Terms related to this study

• Keywords: Cerebral Palsy; selective motor control; Hemiplegia; Extracorporeal Shock Wave Therapy
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Brain Damage, Chronic; Cerebral Palsy; Paralysis
• Other Study ID Numbers: taibah university (Deanship of scintific research)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No