NCT06930287

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.

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Mar 2025

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

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

March 31, 2025

Completed
Same day until next milestone

Study Start

First participant enrolled

March 31, 2025

Completed
16 days until next milestone

First Posted

Study publicly available on registry

April 16, 2025

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2025

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2025

Completed
Last Updated

April 16, 2025

Status Verified

April 1, 2025

Enrollment Period

3 months

First QC Date

March 31, 2025

Last Update Submit

April 15, 2025

Conditions

Sport Injury

Keywords

halffootsports shoedaily trainingcompetition

Outcome Measures

Primary Outcomes (1)

  • functional equine

    footprints measurement with camera and digital goniometer (measured in degrees).

    5 weeks

Secondary Outcomes (1)

  • algometry

    5 weeks

Study Arms (1)

300 mg Nimbus shoe

Other: 250 mg Nimbus shoe

Interventions

250 mg Nimbus shoeOTHER

lightweight shoe

300 mg Nimbus shoe

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

regular runners with functional standing equine

You may qualify if:

  • patients with functional equine
  • regular runners

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Universidad Pontificia de Salamanca

Salamanca, Spain

RECRUITING

Related Publications (6)

  • 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.

    PMID: 30321852BACKGROUND

  • 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.

    PMID: 28257675RESULT

  • Rong K, Ge WT, Li XC, Xu XY. Mid-term Results of Intramuscular Lengthening of Gastrocnemius and/or Soleus to Correct Equinus Deformity in Flatfoot. Foot Ankle Int. 2015 Oct;36(10):1223-8. doi: 10.1177/1071100715588994. Epub 2015 Jun 3.

    PMID: 26041542RESULT

  • Rodriguez-Sanz D, Losa-Iglesias ME, Becerro de Bengoa-Vallejo R, Palomo-Lopez P, Beltran-Alacreu H, Calvo-Lobo C, Navarro-Flores E, Lopez-Lopez D. Skin temperature in youth soccer players with functional equinus and non-equinus condition after running. J Eur Acad Dermatol Venereol. 2018 Nov;32(11):2020-2024. doi: 10.1111/jdv.14966. Epub 2018 May 18.

    PMID: 29601106RESULT

  • Rodriguez-Sanz D, Losa-Iglesias ME, Lopez-Lopez D, Calvo-Lobo C, Palomo-Lopez P, Becerro-de-Bengoa-Vallejo R. Infrared thermography applied to lower limb muscles in elite soccer players with functional ankle equinus and non-equinus condition. PeerJ. 2017 May 25;5:e3388. doi: 10.7717/peerj.3388. eCollection 2017.

    PMID: 28560116RESULT

  • Rodriguez-Sanz D, Losa-Iglesias ME, Becerro-de-Bengoa-Vallejo R, Dorgham HAA, Benito-de-Pedro M, San-Antolin M, Mazoteras-Pardo V, Calvo-Lobo C. Thermography related to electromyography in runners with functional equinus condition after running. Phys Ther Sport. 2019 Nov;40:193-196. doi: 10.1016/j.ptsp.2019.09.007. Epub 2019 Sep 25.

    PMID: 31590122RESULT

Study Officials

  • Jorge SAORNIL, PhD.

    Universidad Pontificia de Salamanca

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Jorge Velázquez SAORNIL, PhD.

CONTACT

655909940jvelazquezsa@upsa.es

Study Design

Study Type
observational
Observational Model
CASE CROSSOVER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD. Physiotherapy

Study Record Dates

First Submitted

March 31, 2025

First Posted

April 16, 2025

Study Start

March 31, 2025

Primary Completion

July 1, 2025

Study Completion

December 30, 2025

Last Updated

April 16, 2025

Record last verified: 2025-04

Locations

ES(1)