Footwear Difference in Sports Use in Runners With Functio... | NCT06930287

Studies
Footwear Difference in Sports Use in Runners With Functional Equinus

NCT06930287

Sponsor

Universidad Católica de Ávila

Status

Recruiting

Last Update Posted

Apr 16, 2025Actual

Enrollment

20Estimated

Phase

Not provided

Conditions

Sport Injury

Interventions

250 mg Nimbus shoe

Countries

Spain

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

Apr 2025

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 31, 2025Actual

Primary Completion Date

Jul 1, 2025Estimated

Completion Date

Dec 30, 2025Estimated

First Submitted Date

Mar 31, 2025

First Submission Date that Met QC Criteria

Apr 15, 2025

First Posted Date

Apr 16, 2025Actual

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

Apr 15, 2025

Last Update Posted Date

Apr 16, 2025Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

JORGE VELAZQUEZ SAORNIL, PhD. Physiotherapy, Universidad Católica de ÁvilaPrincipal Investigator

Lead Sponsor

Universidad Católica de ÁvilaOTHER

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

Observational study on Nimbus shoes for daily training with 8mm drop and designed for heavier than normal weight. Shoe weight is 300g with highly structured buttress and upper with internal heat-sealed midfoot for greater lateral stability. This is a Novablast shoe with a mixed profile for training and competition with 8mm drp and higher midfoot compression range with less lateral containment.

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

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

20Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
300 mg Nimbus shoe			Other: 250 mg Nimbus shoe

Interventions

Name	Type	Description	Arm Group Labels	Other Names
250 mg Nimbus shoe	Other	lightweight shoe	300 mg Nimbus shoe

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
functional equine	footprints measurement with camera and digital goniometer (measured in degrees).	5 weeks

Secondary Outcomes

Measure	Description	Time Frame
algometry	pressure pain threshold measured with digital algometer (measured in Newtons).	5 weeks

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

patients with functional equine
regular runners

Exclusion Criteria:

patients with severe heterometry (more than 1 cm).
Recent lower limb interventions

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

50 Years

Standard Ages

Adult

Study Population

regular runners with functional standing equine

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Jorge Velázquez SAORNIL, PhD.	Contact	655909940		jvelazquezsa@upsa.es

Overall Officials

Name	Affiliation	Role
Jorge SAORNIL, PhD.	Universidad Pontificia de Salamanca	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Universidad Pontificia de Salamanca	Recruiting	Salamanca			Spain

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
30321852	Background	MacDonald DRW, Neilly D, Littlechild J, Harrold F, Roberts SC. Acute Achilles tendon rupture: Do cast boots produce adequate equinus when used for functional rehabilitation? Foot (Edinb). 2018 Dec;37:1-4. doi: 10.1016/j.foot.2018.07.004. Epub 2018 Oct 12.
28257675	Result	DeHeer PA. Equinus and Lengthening Techniques. Clin Podiatr Med Surg. 2017 Apr;34(2):207-227. doi: 10.1016/j.cpm.2016.10.008. Epub 2017 Jan 19.