Study of Quantification of Hyperpronation | NCT01587612

Studies
Study of Quantification of Hyperpronation

NCT01587612

Sponsor

Northern Orthopaedic Division, Denmark

Status

Completed

Last Update Posted

Mar 31, 2014Estimated

Enrollment

80Actual

Phase

Not provided

Conditions

Foot Pain Chronic

Interventions

Not provided

Countries

Denmark

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

Mar 2014

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 2003

Primary Completion Date

Dec 2003Actual

Completion Date

Mar 2004Actual

First Submitted Date

Jan 5, 2011

First Submission Date that Met QC Criteria

Apr 26, 2012

First Posted Date

Apr 30, 2012Estimated

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

Mar 28, 2014

Last Update Posted Date

Mar 31, 2014Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

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

Hyperpronation is af frequent cause of excessive load in foot and crus. Pain and limited functional ability cause problems with work-related activities, sport activities and leisure activities.

There are only few studies of the frequency of pain related to hyperpronation in foot and the effect of exercises. Medics and physiotherapists need sufficient evidence-based knowledge to treat these patients correctly.

Therefore, the investigators want to study the effect of exercises and inner soles for treatment of patients with chronic pain and hyperpronation of foot.

Detailed Description

Not provided

Design Module

Study Type

Observational

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 provided

Interventional Study Design

No data available

No data is available for this block.

Biospecimen

No data available

No data is available for this block.

Enrollment

80Actual

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Hyperpronation of foot
Consent of information

Exclusion Criteria:

Normal gait
Lack of consent of information
Unable to speak and read Danish

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

68 Years

Standard Ages

AdultOlder Adult

Study Population

Hyperpronation of foot

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Mogens B Laursen, MD	Northern Orthopaedic Division	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Northern Orthopaedic Division, Klinik Aalborg		Aalborg	Northern Jutland		Denmark

Condition Browse Module

MeSH Terms

ID	Term
D010146	Pain

Ancestor Terms

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

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Browse Branches

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