Hemiplegic Cerebral PalsyNCT05607134
Effect of Extracorporeal Shock Wave and Peripheral Magnetic Stimulation on Spastic CP Children
A study testing selected physical and occupational therapy program, Radial Extracorporeal Shock Wave and Peripheral magnetic stimulation in people with Hemiplegic Cerebral Palsy, run by Cairo University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 6 to 10 years
- Conditions the study is for
- Hemiplegic Cerebral Palsy
- What is being tested?
- selected physical and occupational therapy program, Radial Extracorporeal Shock Wave and Peripheral magnetic stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 45 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jan 2023to May 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 10 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- • 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.
Who cannot join
- • 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.
Trial locations and contacts
1 site in 1 country.
Mohamed A. Elshafey, PHD contact
Egypt1 site, 1 recruiting
- Recruiting
Faculty of Physical Therapy
Cairo, 11571
Hany A Saad, 01007941809
About this study
Official title: 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.
Read the 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.
- Conditions
- Hemiplegic Cerebral Palsy
- Being tested
- selected physical and occupational therapy program, Radial Extracorporeal Shock Wave, Peripheral magnetic stimulation
- Keywords
- Hemiplegic Cerebral palsy, Radial Extracorporeal Shock Wave, Peripheral magnetic stimulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
selected physical and occupational therapy programOther
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 WaveDevice
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 stimulationDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Physical and occupational therapy group | Sham comparator | The group will receive a Physical and occupational therapy program Receives: Other: selected physical and occupational therapy program |
| Shock Wave group | Active comparator | The group will receive a radial Extracorporeal Shock Wave sessions Receives: Device: Radial Extracorporeal Shock Wave |
| Peripheral Magnetic Stimulation group | Active comparator | The group will receive a Peripheral Magnetic Stimulation sessions Receives: Device: Peripheral magnetic stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: at the beginning and after eight weeks of the intervention
Secondary outcomes (3)
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.
Measured: 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).
Measured: 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)
Measured: at the beginning and after eight weeks of the intervention.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2022
- Study start1 Jan 2023
- Primary completionDec 2023 (estimated)
- Study completionMay 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hemiplegic Cerebral PalsyStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hany Abdelaziz Saad, Cairo University
- Investigators
- Hany A. Saad, M. SC., Principal investigator, Cairo UniversityKHALED A. MAMDOUH, PHD, Study chair, Prof. of Physical Therapy for Pediatrics, Faculty of Physical Therapy, Cairo UniversityHoda A. EL-TALAWY, PHD, Study director, Prof. of Ph.Th. for Pediatrics, Faculty of Physical Therapy, Cairo UniversityMohamed A. Elshafey, PHD, Study director, Ass. Prof. of Physical Therapy for Pediatrics, Faculty of Physical Therapy, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05607134
- Sponsor's protocol ID
- 012/003862
- Status last verified
- Feb 2023
- First submitted
- 27 Oct 2022
- Last updated
- 8 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Radial Extracorporeal Shock Wave and Peripheral Magnetic Stimulation on Upper Limb in Children With Spastic Hemiplegia
- ClinicalTrials.gov ID
- NCT05607134
- Acronym / sponsor ID
- 012/003862
- Conditions
- Hemiplegic Cerebral Palsy
- Keywords
- Hemiplegic Cerebral palsy, Radial Extracorporeal Shock Wave, Peripheral magnetic stimulation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Jan 2023 (actual)
- Primary completion
- Dec 2023 (estimated)
- Study completion
- May 2024 (estimated)
- First posted
- 7 Nov 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Physical and occupational therapy group | Sham comparator | Other: selected physical and occupational therapy programThe group will receive a Physical and occupational therapy program |
| Shock Wave group | Active comparator | Device: Radial Extracorporeal Shock WaveThe group will receive a radial Extracorporeal Shock Wave sessions |
| Peripheral Magnetic Stimulation group | Active comparator | Device: Peripheral magnetic stimulationThe group will receive a Peripheral Magnetic Stimulation sessions |
Who may qualify
- Ages
- 6 to 10 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- • Spastic hemiplegic children will be included in this study.
Key exclusion criteria (7 listed)
- • History of recent nonunion fracture of the upper extremities.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| selected physical and occupational therapy programThe children in this group will receive a selected physical and occupational therapy programs one hour three times weekly for eight successive weeks. | Other | Physical and occupational therapy group |
| Radial Extracorporeal Shock WaveThe 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. | Device | Shock Wave group |
| Peripheral magnetic stimulationThe 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. | Device | Peripheral Magnetic Stimulation group |
Primary outcome
Change of the muscle tone of the wrist flexors
Time frame: at the beginning and after eight weeks of the intervention
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).
3 secondary outcomes
Change of wrist extension range of motion (ROM)
Time frame: at the beginning and after eight weeks of the intervention.
Change of handgrip strength
Time frame: at the beginning and after eight weeks of the intervention.
Change of Functionality of wrist and hand
Time frame: at the beginning and after eight weeks of the intervention.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mohamed A. Elshafey, PHD contact
Hany A. Saad, M. SC. principal investigator
Cairo University
KHALED A. MAMDOUH, PHD study chair
Prof. of Physical Therapy for Pediatrics, Faculty of Physical Therapy, Cairo University
Hoda A. EL-TALAWY, PHD study director
Prof. of Ph.Th. for Pediatrics, Faculty of Physical Therapy, Cairo University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing selected physical and occupational therapy program, Radial Extracorporeal Shock Wave and Peripheral magnetic stimulation in people with Hemiplegic Cerebral Palsy, run by Cairo University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hany A. Saad, M.Sc. (00201007941809, Habdelaziz159@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of the muscle tone of the wrist flexors (time frame: at the beginning and after eight weeks of the intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Feb 2023.