Shock Wave and Spastic Cerebral Palsy Equines Foot

NCT04835753 | Unknown

• 1 other identifier: taibah university
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

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.

Conditions

Cerebral Palsy

Keywords

Cerebral Palsy; Extracorporeal Shock Wave Therapy; Hemiplegia; selective motor control

Outcome Measures

Primary Outcomes (4)

• 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

Study Arms (2)

study group

EXPERIMENTAL

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

control group

OTHER

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

Interventions

shock wave DEVICE

true radial ESWT.A rESW pneumatic device (SHOCK MED, Italy) was used to provide one session per week (for a total of 12-week)

study group

traditional physical therapy program OTHER

lower limbs muscles stretch and strength in addition to balance and gait training

control group; study group

Eligibility Criteria

• Age: 7 Years - 9 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• \) 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

You may not qualify if:

• \) 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.

Sponsors & Collaborators

• Taibah University: lead

Study Sites (1)

Taibah University

Al Madīnah, 42353, Saudi Arabia

Location

MeSH Terms

Conditions

Cerebral Palsy; Hemiplegia

Interventions

Extracorporeal Shockwave Therapy

Condition Hierarchy (Ancestors)

Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Paralysis; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Ultrasonic Therapy; Diathermy; Hyperthermia, Induced; Therapeutics; Physical Therapy Modalities; Rehabilitation

Study Officials

• hatem emaraa, PHD

  Taibah University,saudi arabia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: DR

Study Record Dates

• First Submitted: April 5, 2021
• First Posted: April 8, 2021
• Study Start: January 1, 2021
• Primary Completion: March 30, 2021
• Study Completion: May 15, 2021
• Last Updated: April 8, 2021

Record last verified: 2021-04

Locations

SA (1)