Effect of Extracorporeal Shock Wave and Peripheral Magnetic Stimulation on Spastic CP Children

NCT05607134 | Unknown

• 1 other identifier: 012/003862
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

Brief Summary

Hypotheses: There will be an effect of radial extracorporeal shock wave therapy and peripheral magnetic stimulation on the following parameters, in children with spastic hemiplegia:

• Wrist flexors spasticity.
• Wrist joint range of motion.
• Hand grip muscles strength.
• Sensorimotor function of wrist and hand.

Conditions

Hemiplegic Cerebral Palsy

Keywords

Hemiplegic Cerebral palsy; Radial Extracorporeal Shock Wave; Peripheral magnetic stimulation

Outcome Measures

Primary Outcomes (1)

• Change of the muscle tone of the wrist flexors

  The muscle tone of the wrist flexors will be assessed with The Modified Tardieu Scale (MTS) . This test is done in the supine position, with head in midline, and is measured at 3 different velocities (V1, V2, and V3). V1: as slow as possible (slower than the natural drop of the limb segment under gravity. V2: speed of limb segment falling under gravity. V3: as fast as possible faster than the rate of the natural drop of the limb segment under gravity. Measuring R1 (the fast velocity movement of the wrist through the full ROM to determine the point of catch in the ROM), R2 (the passive ROM), and R2-R1 (dynamic component of spasticity).

  at the beginning and after eight weeks of the intervention

Secondary Outcomes (3)

• Change of wrist extension range of motion (ROM)

  at the beginning and after eight weeks of the intervention.

• Change of handgrip strength

  at the beginning and after eight weeks of the intervention.

• Change of Functionality of wrist and hand

  at the beginning and after eight weeks of the intervention.

Study Arms (3)

Physical and occupational therapy group

SHAM COMPARATOR

The group will receive a Physical and occupational therapy program

Other: selected physical and occupational therapy program

Shock Wave group

ACTIVE COMPARATOR

The group will receive a radial Extracorporeal Shock Wave sessions

Device: Radial Extracorporeal Shock Wave

Peripheral Magnetic Stimulation group

ACTIVE COMPARATOR

The group will receive a Peripheral Magnetic Stimulation sessions

Device: Peripheral magnetic stimulation

Interventions

selected physical and occupational therapy program OTHER

The children in this group will receive a selected physical and occupational therapy programs one hour three times weekly for eight successive weeks.

Physical and occupational therapy group

Radial Extracorporeal Shock Wave DEVICE

The children in this group will receive in addition to the selected physical therapy and occupational program as single session of shock wave intervention once per week for four eight successive weeks using (STORZ MEDICAL AG, Tagerwilen, Schweiz) device. rESWT will be applied on flexor carpi ulnaris, flexor carpi radialis, in the middle of the muscle belly and tendons of flexor digitorum on the palm. The treatment protocol of rESW will follow; 1500 shoots for each muscle; 0.030 mj/mm2; 4 HZ with pressure 1 bar will be used.

Shock Wave group

Peripheral magnetic stimulation DEVICE

The children in this group will receive in addition to the selected physical therapy program peripheral magnetic stimulation (PMS) therapy for twenty minutes, three sessions per week, for eight successive weeks using Peripheral magnetic stimulation device "A MAGNUM XL Pro, Globus, Italia". The PMS consisted of 2000 stimuli at a stimulation frequency of 20Hz, a train duration of 1 second, and an intertrain interval of 2 seconds. Intensity was individually set at 10% to 100% of the maximum stimulus intensity.

Peripheral Magnetic Stimulation group

Eligibility Criteria

• Age: 6 Years - 10 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Spastic hemiplegic children will be included in this study.
• The children ages will be ranged from 6-10 years chronologically.
• Children will have wrist flexors degree of spasticity ranged from +1 to 2 on Modified Ashworth Scale.
• The children will have Level III to Level IV according to the Manual Ability Classification System.
• All children will be medically stable.
• Children take their anti-spasticity medications.
• All children will be able to follow instructions.

You may not qualify if:

• History of recent nonunion fracture of the upper extremities.
• Neurological or orthopedic surgery in the upper extremities in the last 12 months before the study.
• Received Botulinum toxin A injections in the last six months.
• Fixed contractures and deformities.
• Patients with a self-contained medical implant such as: a metal plate along the spastic limbs, pacemaker, cochlear implant, and so on.
• Children with cognitive dysfunction.
• Poor skin integrity.

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Faculty of Physical Therapy

Cairo, 11571, Egypt

RECRUITING

Study Officials

• Hany A. Saad, M. SC.

  Cairo University

  PRINCIPAL INVESTIGATOR

• KHALED A. MAMDOUH, PHD

  Prof. of Physical Therapy for Pediatrics, Faculty of Physical Therapy, Cairo University

  STUDY CHAIR

• Hoda A. EL-TALAWY, PHD

  Prof. of Ph.Th. for Pediatrics, Faculty of Physical Therapy, Cairo University

  STUDY DIRECTOR

• Mohamed A. Elshafey, PHD

  Ass. Prof. of Physical Therapy for Pediatrics, Faculty of Physical Therapy, Cairo University

  STUDY DIRECTOR

Central Study Contacts

Hany A. Saad, M.Sc.

CONTACT

00201007941809; Habdelaziz159@gmail.com

Mohamed A. Elshafey, PHD

CONTACT

0020 106 717 9565

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: October 27, 2022
• First Posted: November 7, 2022
• Study Start: January 1, 2023
• Primary Completion: December 1, 2023
• Study Completion: May 1, 2024
• Last Updated: February 8, 2023

Record last verified: 2023-02

Locations

EG (1)