Effect of Extracorporeal Shock Wave and Peripheral Magnetic Stimulation on Spastic CP Children
NCT ID: NCT05607134
Last Updated: 2023-02-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
45 participants
INTERVENTIONAL
2023-01-01
2024-05-31
Brief Summary
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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.
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Physical and occupational therapy group
The group will receive a Physical and occupational therapy program
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.
Shock Wave group
The group will receive a radial Extracorporeal Shock Wave sessions
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.
Peripheral Magnetic Stimulation group
The group will receive a Peripheral Magnetic Stimulation sessions
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.
Interventions
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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.
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.
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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
6 Years
10 Years
ALL
No
Sponsors
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Cairo University
OTHER
Responsible Party
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Hany Abdelaziz Saad
Principal investigator
Principal Investigators
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Hany A. Saad, M. SC.
Role: PRINCIPAL_INVESTIGATOR
Cairo University
KHALED A. MAMDOUH, PHD
Role: STUDY_CHAIR
Prof. of Physical Therapy for Pediatrics, Faculty of Physical Therapy, Cairo University
Hoda A. EL-TALAWY, PHD
Role: STUDY_DIRECTOR
Prof. of Ph.Th. for Pediatrics, Faculty of Physical Therapy, Cairo University
Mohamed A. Elshafey, PHD
Role: STUDY_DIRECTOR
Ass. Prof. of Physical Therapy for Pediatrics, Faculty of Physical Therapy, Cairo University
Locations
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Faculty of Physical Therapy
Cairo, , Egypt
Countries
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Central Contacts
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Mohamed A. Elshafey, PHD
Role: CONTACT
Facility Contacts
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Hany A Saad
Role: primary
Other Identifiers
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012/003862
Identifier Type: -
Identifier Source: org_study_id
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