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

Effect of Radial Extracorporeal Shock Wave and Peripheral Magnetic Stimulation on Upper Limb in Children With Spastic Hemiplegia

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.

Study Overview

• Status: Recruiting
• Conditions: Hemiplegic Cerebral Palsy
• Intervention / Treatment: Other: selected physical and occupational therapy program; Device: Radial Extracorporeal Shock Wave; Device: Peripheral magnetic stimulation

Detailed Description

Significance of the study:

Reducing muscle hypertonia or spasticity in order to regain independent mobility is an essential goal of a physiotherapeutical treatment in neuro-rehabilitation. The rapid normalization of the muscle tone is a criterion that can crucially influence the outcome of future rehabilitation or in training programs.

Purposes of the study:

To evaluate the 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.

Methods:

Forty-five children with hemiplegic cerebral palsy, aged from 6 to 10 years, will be enrolled in this study. Wrist flexors spasticity, Wrist joint range of motion, Hand grip muscles strength, Sensorimotor function of wrist and hand will be assessed.

Data Analysis and statistical design:

Normally distributed numerical data will be statistically described in terms of mean standard deviation, while not-normal data will be represented as median and range or inter-quartile range (IQR). Qualitative (categorical) data will be described in frequencies (number of cases) and percentage. Numerical data will be tested for the normal assumption using Kolmogorov Smirnov test.

Comparison of numerical variables between the study groups will be done using One Way Analysis of variance (ANOVA) test when normally distributed and Kruskal Wallis analysis of variance (ANOVA) test when not normal.

For comparing categorical data, Chi-square test will be performed. Exact test will be used instead when the expected frequency is less than 5.

A probability value (p value) less than 0.05 is considered statistically significant. All statistical calculations will be done using computer programs Microsoft Excel 2019 (Microsoft Corporation, NY, USA) and IBM SPSS (Statistical Package for the Social Science; IBM Corp, Armonk, NY, USA) release 22 for Microsoft Windows.

• Study Type: Interventional
• Enrollment (Anticipated): 45
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt, 11571
    • Recruiting
    • Faculty of Physical Therapy
    • Contact: Hany A Saad; Phone Number: 01007941809

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 years to 10 years (CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• • 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.

Exclusion Criteria:

• • 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: QUADRUPLE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
SHAM_COMPARATOR: Physical and occupational therapy group; The group will receive a Physical and occupational therapy program	Other: selected physical and occupational therapy program; The children in this group will receive a selected physical and occupational therapy programs one hour three times weekly for eight successive weeks.
ACTIVE_COMPARATOR: Shock Wave group; The group will receive a radial Extracorporeal Shock Wave sessions	Device: Radial Extracorporeal Shock Wave; 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.
ACTIVE_COMPARATOR: Peripheral Magnetic Stimulation group; The group will receive a Peripheral Magnetic Stimulation sessions	Device: Peripheral magnetic stimulation; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change of wrist extension range of motion (ROM)	Wrist extension will be measured for all children according to Norkin and White (2016) as follows: Each child was placed in sitting next to a supporting surface with the elbow flexed to 90 degrees, and the palm of the hand facing the ground. The forearm was rested on the supporting surface, but the hand was leaved free to move without radial or ulnar deviation of the wrist. The children were asked to extend the wrist by moving the hand in a dorsal direction toward the ceiling with maintaining the wrist in 0 degrees of radial and ulnar deviation. Goniometer alignment: Fulcrum of the goniometer was placed on the lateral aspect of the wrist over the triquetrum.; Proximal arm was aligned with the lateral midline of the ulna, using the olecranon and ulnar styloid process for reference.; Distal arm was aligned with the lateral midline of the fifth metacarpal.	at the beginning and after eight weeks of the intervention.
Change of handgrip strength	The isometric muscle strength of hand grip will be measured with a handheld dynamometer. The position of the dynamometer will be standardized for each measurement. A 'make' test will be employed with the tester setting a constant resistive force for 3 to 5 seconds, directed perpendicular to the long axis of the limb segment to elicit an isometric muscle contraction. A standard instruction of 'close your hand as hard as you can' is given to each participant for each trial (Berry et al., 2004). Children will be given two practical trials until the investigator will be confident that they understand the task. Each child will perform three trials, strong verbal encouragement will be used during the trial to achieve maximum effort and the peak force values from dynamometer will be recorded (Thompson et al., 2011).	at the beginning and after eight weeks of the intervention.
Change of Functionality of wrist and hand	The upper extremity section of the Fugl-Meyer Assessment (FMA-UE) is used. The FMA-UE wrist and hand motor and sensory subscores are graded, and the scores are added (total 36 scores). Each domain contains multiple items, each scored on a 3-point ordinal scale (0, cannot perform; 1, performs partially; 2, performs fully) (Fugl-Meyer et al., 1975; Krewer et al., 2014)	at the beginning and after eight weeks of the intervention.

Collaborators and Investigators

• Sponsor: Cairo University

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 1, 2023
• Primary Completion (ANTICIPATED): December 1, 2023
• Study Completion (ANTICIPATED): May 1, 2024

Study Registration Dates

• First Submitted: October 27, 2022
• First Submitted That Met QC Criteria: November 1, 2022
• First Posted (ACTUAL): November 7, 2022

Study Record Updates

• Last Update Posted (ACTUAL): February 8, 2023
• Last Update Submitted That Met QC Criteria: February 7, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Keywords: Hemiplegic Cerebral palsy; Radial Extracorporeal Shock Wave; Peripheral magnetic stimulation
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Brain Damage, Chronic; Cerebral Palsy
• Other Study ID Numbers: 012/003862

Drug and device information, study documents

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