- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03857555
Causes of Peripheral Hypotonia in Assiut University Children Hospital
Causes of Peripheral Hypotonia in Children Attending Assiut University Children Hospital
Hypotonia is a common manifestation in infants and children.It includes several clinical conditions that do not always lead to a favorable outcome .Thus, it is important to make early diagnosis to decide on the treatment and follow up of these cases. Hypotonia is a state of low muscle tone (The amount of tension or resistance to stretch on a muscle), often pointing to reduced muscle strength.
Hypotonia is not a specific medical disorder, but a potential manifestation of several diseases and disorders, that affect motor nerve control by the brain or muscle strength.
Study Overview
Status
Conditions
Detailed Description
Criteria of peripheral hypotonia are : absent or depressed tendon reflexes , failure of movements on postural reflexes ,fasciculation with or without muscle atrophy .A sequential scheme of localization would begin with the anterior horn cell (AHC), and progress to the peripheral nerve , neuromuscular junction (NMJ) and the muscle itself.
Electroneuromyography (ENMG) provides useful information on many neuromuscular diseases. In addition nerve conduction study is also helpful to identify the most common peripheral disorders causing hypotonia in these children.
The initial approach to hypotonia is to determine whether the problem is due to central or peripheral origin.This is of crucial importance when forming a plan for diagnostic investigations and management.
Many muscle diseases share common clinical features that may lead to laboratory diagnosis by using enzyme levels that are affected in some of these diseases(e.g creatine phosphokinase ). However the use of serum creatine phosphokinase level may not possibly differentiate between various muscle diseases . The selective involvement of certain muscles is a key to the diagnosis of muscle disease].
High resolution ultrasound allows visualization of the muscle, nerve and adjacent structures and can offer real-time information regarding neuromuscular diseases. It can be used as a helping tool to electrodiagnosis with estimation of the serum creatine phosphokinase levels of these cases.
The aim of this work :is to give a profile of the causes of peripheral hypotonia in infant and children attending Assiut University Children Hospital during one year of the study .
Besides full clinical assessment of the cases including birth history , developmental history, age, sex, and duration of illness as well as age of onset of observed weakness will be recorded. Full neurological examination will be done in all cases .Cases will have serum creatine phosphokinase levels, electromyography and nerve conduction studies done as indicated.Cases will also have real time muscle ultrasonography done.
- Our results will be compared with the results obtained by other investigators .
- Statistical analysis : correlation studies will be done between the various methods of investigations used .Chi2 test will be used to indicate the prevalence of the various causes of hypotonia found in the study .
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Contact
- Name: Safia Eldeebb
- Phone Number: 0882060380
- Email: safia.eldeeb@med.au.edu.eg
Study Contact Backup
- Name: Eman Fatth_alla
- Phone Number: 01115191158
- Email: eman.mohamed@med.au.edu.eg
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- all infant and children with peripheral hypotonia
Exclusion Criteria:
- central causes of hypotonia
Study Plan
How is the study designed?
Design Details
- Observational Models: Other
- Time Perspectives: Cross-Sectional
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
To detect the role of combin- ing clinical and radiological assessments in the diagnosis of muscle diseases and the possibility of using muscle ultrasound as a screening tool when muscle diseases are suspected.
Time Frame: 30 minutes,
|
Muscles ultrasounds will perform using Phillips HD15000, brand ATL,model HTI 5000,and Origin USA linear probe 5_12MHz.The probe will use in a transverse plane,perpendicular to the long axis of the muscle.The muscle will examine through its whole length dynamically inspect for any spontaneous activity at rest. The following muscles will be inspected :1.anterior thigh:rectus femoris,vastus intermedius,lateral is and medial is,sartorius, and gracilis,2.posterior thigh:adductors,biceps femoris,semitendinous, semimembranosus, (c) leg:tepialis anterior,peronii, and gastrocnemius soleus. We will employ a visual grading system to detect whether the muscles affected. Normal muscle appears with low echo_intensity divided by ecchogenic perimysium and connective tissue with speckled appearance in the transverse plane.The muscle will be considered abnormal if it shows increase ecchogenicity, lost its striation, or show change in muscle bulk. |
30 minutes,
|
Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- Helmy H, Aboumousa A, Abdelmagied A, Alsayyad A, Nasr SA. The role of muscle ultrasound in helping the clinical diagnosis of muscle diseases. Egypt J Neurol Psychiatr Neurosurg. 2018;54(1):29. doi: 10.1186/s41983-018-0039-6. Epub 2018 Nov 1.
- Cetin E, Cuisset JM, Tiffreau V, Vallee L, Hurtevent JF, Thevenon A. The value of electromyography in the aetiological diagnosis of hypotonia in infants and toddlers. Ann Phys Rehabil Med. 2009 Sep-Oct;52(7-8):546-55. doi: 10.1016/j.rehab.2009.06.004. Epub 2009 Aug 18. English, French.
Study record dates
Study Major Dates
Study Start (Anticipated)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- COPHIAUCH
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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