NCT03857555

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
35

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Apr 2020

Shorter than P25 for all trials

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 14, 2019

Completed
14 days until next milestone

First Posted

Study publicly available on registry

February 28, 2019

Completed
1.1 years until next milestone

Study Start

First participant enrolled

April 1, 2020

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2021

Completed
Last Updated

February 28, 2019

Status Verified

February 1, 2019

Enrollment Period

1 year

First QC Date

February 14, 2019

Last Update Submit

February 26, 2019

Conditions

Outcome Measures

Primary Outcomes (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.

    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,

Eligibility Criteria

AgeUp to 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodProbability Sample
Study Population

This study will be conducted in the neuro-pediatric clinic at Assiut University Hospital after approval from the ethical review board.Tthirty five infant and children with peripheral hypotonia will be evaluated to reach a diagnosis

You may qualify if:

  • all infant and children with peripheral hypotonia

You may not qualify if:

  • central causes of hypotonia

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (2)

  • 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.

    PMID: 30459502BACKGROUND
  • 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.

MeSH Terms

Conditions

Muscle Hypotonia

Condition Hierarchy (Ancestors)

Neuromuscular ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Central Study Contacts

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
principle investigator

Study Record Dates

First Submitted

February 14, 2019

First Posted

February 28, 2019

Study Start

April 1, 2020

Primary Completion

April 1, 2021

Study Completion

April 1, 2021

Last Updated

February 28, 2019

Record last verified: 2019-02