NCT06420856

Brief Summary

The effect of muscular strength deficits on postural control after Lisfranc injury has been explained in relation to stance duration and strength. However, the relationship between protective sole sensation and changes in ankle proprioception, balance, ankle mobility and Achilles tendon structural properties has been shown in previous studies. The aim of our study was to determine the possible changes in protective sole sensation, ankle proprioception, balance and functional capacity after Lisfranc injury and to analyse the relationship between these variables.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
23

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jan 2024

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 2, 2024

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

May 15, 2024

Completed
2 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 17, 2024

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 20, 2024

Completed
19 days until next milestone

Study Completion

Last participant's last visit for all outcomes

June 8, 2024

Completed
Last Updated

June 21, 2024

Status Verified

June 1, 2024

Enrollment Period

5 months

First QC Date

May 15, 2024

Last Update Submit

June 19, 2024

Conditions

Keywords

ProprioceptionPostural BalanceFoot Injuries

Outcome Measures

Primary Outcomes (1)

  • Difference in plantar sensation in people with Lisfranc injuries compared to healthy people

    Our primary outcome is to determine the difference in plantar sensation changes in people with Lisfranc injuries after treatment compared to healthy volunteers with similar demographic characteristics. According to the monofilament test results, increasing numerical values indicate that proprioception is negatively affected.

    2 months

Secondary Outcomes (3)

  • AOFAS (American Orthopaedic Foot and Ankle Society) midfoot Score

    1 months

  • FAOS (Foot and Ankle Outcome Score) Score

    1 months

  • Modified Star Excursion Test

    1 months

Study Arms (2)

Lisfranc injury patients

Sense of light touch will be used with the Semmes-Weinstein Monofilament test, Proprioception evaluation will be used with the Dr.Goniometer application, Muscular strength and endurance will be evaluated with the cybex isokinetic device, Weight-Bearing Lunge test will be used to evaluate ankle mobility and Modified Star Excursion Balance Test will be used to evaluate dynamic balance. Patients' functional levels will be evaluated under two headings: 1. Questionnaire-based functional evaluation: American Orthopedic Foot and Ankle Society (AOFAS) midfoot score and foot and ankle functions Rating Foot and Ankle Outcome Score (FAOS) will be used and will be evaluated. 2. Physical performance evaluation: Heel raise test would be used

Other: Assessment of the musculoskeletal system and its functions

Healthy Volunteers

Sense of light touch will be used with the Semmes-Weinstein Monofilament test, Proprioception evaluation will be used with the Dr.Goniometer application, Muscular strength and endurance will be evaluated with the cybex isokinetic device, Weight-Bearing Lunge test will be used to evaluate ankle mobility and Modified Star Excursion Balance Test will be used to evaluate dynamic balance. Patients' functional levels will be evaluated under two headings: 1. Questionnaire-based functional evaluation: American Orthopedic Foot and Ankle Society (AOFAS) midfoot score and foot and ankle functions Rating Foot and Ankle Outcome Score (FAOS) will be used and will be evaluated. 2. Physical performance evaluation: Heel raise test would be used

Other: Assessment of the musculoskeletal system and its functions

Interventions

Measurement of sub sole pressure sense, light touch sense, vibration sense and two-point discrimination sense. will be evaluated with. For the evaluation of proprioception, active joint position sense technique was used in plantar flexion (PF): 7°, 14° and 21°; In dorsiflexion (DF), 7° target angles will be used. An Dr. Goniometer will be used to determine target angles. To measure plantarflexion and dorsiflexion muscular strength and endurance will be used with the isokinetic system. Weight-Bearing Lunge test will be used to evaluate ankle mobility. For balance assessment, the Modified Star Excursion Balance Test will be measured using the anterior, posteromedial and posterolateral directions. American Orthopedic Foot and Ankle Society midfoot score and foot and ankle functions Rating Foot and Ankle Outcome Score , which are subjective evaluation methods, will be used to determine the functional level. A heel lift test will be performed to evaluate physical performance.

Healthy VolunteersLisfranc injury patients

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

A total of 24 people will be included in our study. It will be conducted with 12 Lisfranc injury patients and 12 healthy volunteer participants. All participants will be over 18 years of age.

You may qualify if:

  • Having had a Lisfranc injury
  • Having only one extremity injured
  • Having received surgical treatment
  • Being over 18 years old

You may not qualify if:

  • Having a neurological problem,
  • diabetes
  • smoking
  • untreated Lisfranc injury
  • incomplete medical record
  • not wanting to participate in the study
  • having a neurovascular injury
  • Being healthy
  • Any foot pain, history of fractures, etc. Absence of circumstances
  • Being over 18 years of age
  • Not being healthy
  • Any foot pain, history of fractures, etc.
  • Not being over 18 years of age

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

İstanbul Tıp Fakültesi Ortopedi ve Travmatoloji Anabilimdalı

Istanbul, Fatih, 34093, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Foot Injuries

Condition Hierarchy (Ancestors)

Leg InjuriesWounds and Injuries

Study Officials

  • ALİ İLEZ

    Istanbul Saglik Bilimleri University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Assistant

Study Record Dates

First Submitted

May 15, 2024

First Posted

May 20, 2024

Study Start

January 2, 2024

Primary Completion

May 17, 2024

Study Completion

June 8, 2024

Last Updated

June 21, 2024

Record last verified: 2024-06

Data Sharing

IPD Sharing
Will not share

Locations