Relation Between Near Point of Convergence and Postural S... | NCT04767386

Studies
Relation Between Near Point of Convergence and Postural Stability in Subjects with Non Specific Cervical Pain

NCT04767386

Sponsor

Cairo University

Status

Completed

Last Update Posted

Nov 1, 2024Actual

Enrollment

80Actual

Phase

Not provided

Conditions

Neck Pain

Interventions

Not provided

Countries

Egypt

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2021

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 15, 2018Actual

Primary Completion Date

Jan 20, 2019Actual

Completion Date

May 10, 2020Actual

First Submitted Date

Feb 19, 2021

First Submission Date that Met QC Criteria

Feb 22, 2021

First Posted Date

Feb 23, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 31, 2024

Last Update Posted Date

Nov 1, 2024Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

Brief Summary

A correlation study was conducted to correlate between the convergence insufficiency and postural stability at three different cervical positions in patients with non-specific cervical pain.

Detailed Description

A correlational study was conducted on eighty (male and female) subjects aged between 30-40 years old, presented with chronic NSCP persisted for six months or more, with neck disability index score (NDI) ≥10%, and can possess at least 45° of left and right cervical rotation participated in the study. Convergence insufficiency was evaluated by the near point of conversion (NPOC) rule and postural instability was examined by the Biodex balance system. RESULTS: There was significant positive correlation between (NPOC) and anteroposterior stability index (APSI) at the three cervical positions; neutral, 45° right torsion and 45° left torsion (P>0.05).

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

80Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Stability index	Antero-posterior and mediolateral stability index	during the procedure
The near point of convergence (NPOC)	The near point of convergence (NPOC) measured by NPOC rule	during the procedure
The CROM	cervical flexion, extension, rotation and lateral flexion	during the procedure

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Age from 30 to 40 years.
Chronic cervical pain ( 6 to18 months ago).
Neck Disability Index (NDI) score ≥10%),
Move 45° of cervical rotation to both the left and right.

Exclusion Criteria:

-Neuromuscular or musculoskeletal disorders.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

30 Years

Maximum Age

40 Years

Standard Ages

Adult

Study Population

Egyptian subjects

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Wael Shendy, PhD	Cairo University	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Faculty of Physical Therapy Cairo University		Giza	Cairo Governorate	12613	Egypt

Condition Browse Module

MeSH Terms

ID	Term
D019547	Neck Pain

Ancestor Terms

ID	Term
D010146	Pain
D009461	Neurologic Manifestations
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

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