Hallux Valgus Conservative Treatment | NCT05165134

Studies
Hallux Valgus Conservative Treatment

NCT05165134

Sponsor

University of Jazan

Status

Completed

Last Update Posted

Dec 21, 2021Actual

Enrollment

30Actual

Phase

Not Applicable

Conditions

Hallux Valgus

Interventions

Kinesiotape

Countries

Saudi Arabia

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

Dec 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

Aug 24, 2020Actual

Primary Completion Date

Jan 29, 2021Actual

Completion Date

Nov 15, 2021Actual

First Submitted Date

Dec 5, 2021

First Submission Date that Met QC Criteria

Dec 20, 2021

First Posted Date

Dec 21, 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

Dec 20, 2021

Last Update Posted Date

Dec 21, 2021Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Mohammed Moustafa, assistant Professor of physical therapy, University of JazanPrincipal Investigator

Lead Sponsor

University of JazanOTHER_GOV

Collaborators

Not provided

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

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Studying the effect of kinesiotape on hallux valgus angle and pain in hallux valgus patients.

Detailed Description

30 patients (male and female) suffering from bilateral Halux valgus. Divided randomly into 2 groups

st group receive kinesiotape bilaterally for correction : Hallux valgus angle (HVA) was measured using Xray and pain was measured using VAS before applying tape and after 8 weeks of tape application.
nd group receive placebo tape bilaterally and had the same measurements.

2 groups were on a group of exercises

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

30Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Experimental kinesiotape group A	Experimental	Kinesiotape group	Other: Kinesiotape
Placebo kinesiotape group B	Placebo Comparator	Control group	Other: Kinesiotape

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Kinesiotape	Other	Elastic tape used for mechanical correction of the deformity in study group and placebo in control group	Experimental kinesiotape group A Placebo kinesiotape group B

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Hallux valgus angle (HVA )	Hallux valgus angle measured by x ray	8 weeks
Pain on metatarsophalangeal joint measured by visual analogue scale (VAS)		8 weeks

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

mobile hallux valgus

Exclusion Criteria:

using orthotics
knee malalignment

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

40 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Mohamed M Ahmed	Assistant Professor of physical therapy	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Jazan University		Jizan	Jazan Region	45142	Saudi Arabia

IPD Sharing Statement Module

Plan to Share IPD

Yes

Description

All will be accessible on request

Types

Study Protocol

Time Frame

March 2022

Access Criteria

Thru e mail

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D006215	Hallux Valgus

Ancestor Terms

ID	Term
D005530	Foot Deformities
D009140	Musculoskeletal Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D055052	Athletic Tape

Ancestor Terms

ID	Term
D001458	Bandages
D004864	Equipment and Supplies
D009989	Orthotic Devices
D009983	Orthopedic Equipment

Browse Leaves

Not provided

Browse Branches

Not provided