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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:
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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Physical and occupational therapy group | Sham Comparator | The group will receive a Physical and occupational therapy program |
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| Shock Wave group | Active Comparator | The group will receive a radial Extracorporeal Shock Wave sessions |
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| Peripheral Magnetic Stimulation group | Active Comparator | The group will receive a Peripheral Magnetic Stimulation sessions |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| 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 |
| 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:
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Inclusion Criteria:
• Spastic hemiplegic children will be included in this study.
Exclusion Criteria:
• History of recent nonunion fracture of the upper extremities.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Hany A. Saad, M.Sc. | Contact | 00201007941809 | Habdelaziz159@gmail.com | |
| Mohamed A. Elshafey, PHD | Contact | 0020 106 717 9565 |
| Name | Affiliation | Role |
|---|---|---|
| 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 |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Faculty of Physical Therapy | Recruiting | Cairo | 11571 | Egypt |
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| 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. |
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| 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. |
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| 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. |
| 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 |