Causes of Peripheral Hypotonia in Assiut University Children Hospital

Sponsor
Assiut University (Other)
Overall Status
Unknown status
CT.gov ID
NCT03857555
Collaborator
(none)
35
12

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase

    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 Design

    Study Type:
    Observational
    Anticipated Enrollment :
    35 participants
    Observational Model:
    Other
    Time Perspective:
    Cross-Sectional
    Official Title:
    Causes of Peripheral Hypotonia in Children Attending Assiut University Children Hospital
    Anticipated Study Start Date :
    Apr 1, 2020
    Anticipated Primary Completion Date :
    Apr 1, 2021
    Anticipated Study Completion Date :
    Apr 1, 2021

    Outcome Measures

    Primary Outcome Measures

    1. 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. [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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A to 18 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • all infant and children with peripheral hypotonia
    Exclusion Criteria:
    • central causes of hypotonia

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Assiut University

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Azza Abouzeid Zaki, principle investigator, Assiut University
    ClinicalTrials.gov Identifier:
    NCT03857555
    Other Study ID Numbers:
    • COPHIAUCH
    First Posted:
    Feb 28, 2019
    Last Update Posted:
    Feb 28, 2019
    Last Verified:
    Feb 1, 2019
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Feb 28, 2019