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

Primary Purpose

Hemiplegic Cerebral Palsy

Status
Recruiting
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
selected physical and occupational therapy program
Radial Extracorporeal Shock Wave
Peripheral magnetic stimulation
Sponsored by
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hemiplegic Cerebral Palsy focused on measuring Hemiplegic Cerebral palsy, Radial Extracorporeal Shock Wave, Peripheral magnetic stimulation

Eligibility Criteria

6 Years - 10 Years (Child)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Faculty of Physical TherapyRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Sham Comparator

Active Comparator

Active Comparator

Arm Label

Physical and occupational therapy group

Shock Wave group

Peripheral Magnetic Stimulation group

Arm Description

The group will receive a Physical and occupational therapy program

The group will receive a radial Extracorporeal Shock Wave sessions

The group will receive a Peripheral Magnetic Stimulation sessions

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

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.
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).
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)

Full Information

First Posted
October 27, 2022
Last Updated
February 7, 2023
Sponsor
Cairo University
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1. Study Identification

Unique Protocol Identification Number
NCT05607134
Brief Title
Effect of Extracorporeal Shock Wave and Peripheral Magnetic Stimulation on Spastic CP Children
Official Title
Effect of Radial Extracorporeal Shock Wave and Peripheral Magnetic Stimulation on Upper Limb in Children With Spastic Hemiplegia
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 1, 2023 (Actual)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
May 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hemiplegic Cerebral Palsy
Keywords
Hemiplegic Cerebral palsy, Radial Extracorporeal Shock Wave, Peripheral magnetic stimulation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
45 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Physical and occupational therapy group
Arm Type
Sham Comparator
Arm Description
The group will receive a Physical and occupational therapy program
Arm Title
Shock Wave group
Arm Type
Active Comparator
Arm Description
The group will receive a radial Extracorporeal Shock Wave sessions
Arm Title
Peripheral Magnetic Stimulation group
Arm Type
Active Comparator
Arm Description
The group will receive a Peripheral Magnetic Stimulation sessions
Intervention Type
Other
Intervention Name(s)
selected physical and occupational therapy program
Intervention Description
The children in this group will receive a selected physical and occupational therapy programs one hour three times weekly for eight successive weeks.
Intervention Type
Device
Intervention Name(s)
Radial Extracorporeal Shock Wave
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Peripheral magnetic stimulation
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change of the muscle tone of the wrist flexors
Description
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).
Time Frame
at the beginning and after eight weeks of the intervention
Secondary Outcome Measure Information:
Title
Change of wrist extension range of motion (ROM)
Description
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.
Time Frame
at the beginning and after eight weeks of the intervention.
Title
Change of handgrip strength
Description
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).
Time Frame
at the beginning and after eight weeks of the intervention.
Title
Change of Functionality of wrist and hand
Description
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)
Time Frame
at the beginning and after eight weeks of the intervention.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
10 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Hany A. Saad, M.Sc.
Phone
00201007941809
Email
Habdelaziz159@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Mohamed A. Elshafey, PHD
Phone
0020 106 717 9565
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hany A. Saad, M. SC.
Organizational Affiliation
Cairo University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
KHALED A. MAMDOUH, PHD
Organizational Affiliation
Prof. of Physical Therapy for Pediatrics, Faculty of Physical Therapy, Cairo University
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Hoda A. EL-TALAWY, PHD
Organizational Affiliation
Prof. of Ph.Th. for Pediatrics, Faculty of Physical Therapy, Cairo University
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Mohamed A. Elshafey, PHD
Organizational Affiliation
Ass. Prof. of Physical Therapy for Pediatrics, Faculty of Physical Therapy, Cairo University
Official's Role
Study Director
Facility Information:
Facility Name
Faculty of Physical Therapy
City
Cairo
ZIP/Postal Code
11571
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hany A Saad
Phone
01007941809

12. IPD Sharing Statement

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

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