- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06420856
Changes of Various Structures After Lisfranc Injury Compared to Healthy Individuals.
Is There a Relationship Between Protective Sole Sense, Ankle Proprioception, Ankle Mobility and Balance in Patients With Treated Lisfranc Injury?
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
'Lisfranc injury' refers to an injury in which one or more metatarsals are displaced. Lisfranc injury covers a wide network of injuries. It includes various types, including a low-energy sports injury or a high-energy lesion, as well as a purely connective tissue injury. 20% of Lisfranc injuries are undiagnosed or diagnosed late. Early and accurate diagnosis of injuries is a basic requirement for appropriate treatment and prevention of secondary problems that may arise in the long term . Fracture-dislocation in the tarsometatarsal junction of the foot is treated with anatomical reduction, internal fixation or primary arthrodesis. However, many individuals have poor functional outcomes . Anatomical repositioning and excellent postoperative radiographic findings may not result in high patient satisfaction. As a result, no matter what type of treatment is used after Lisfranc injury, it should be supported by a good rehabilitation protocol. As a result of our research in the literature, the investigators encountered studies that performed gait analysis, muscle strength and plantar pressure measurements after Lisfranc injury. However, no study has been encountered examining parameters such as sole sense, proprioception, and balance after injury of the foot, which is the only limb in contact with the ground. After determining these values, revising the rehabilitation protocols specifically for the evaluation parameters will reduce the morbidity rate after injury and accelerate functional recovery.
Rehabilitation protocols that emphasize the use of exercises to improve joint range of motion, muscle strength, neuromuscular coordination, and gait mechanics after foot and ankle injuries have been found to improve function . There is also evidence that the plantar flexor muscles of these patients are weakened after injury. There are also groups of patients who complain of instability when walking barefoot or on uneven ground after foot or ankle injuries. In a different study examining the dynamic plantar pressure distribution, force capacity and postural control change after Lisfranc injury, it was found that atrophy occurred after long-term immobilization in both the injured extremity and the contralateral extremity.
Altered postural control after injury was manifested by a significant decrease in unilateral stance time. Adequate rehabilitation following anatomical open reduction after Lisfranc injury is very important for clinical outcome. A detailed evaluation is required to determine adequate rehabilitation. Considering these studies, evaluating balance will be important for patients with Lisfranc injuries.In our study, the investigators aim to provide information about postural control change after injury by evaluating dynamic balance with the Modified star excursion test. In this way, the intensity of balance exercises can be adjusted while shaping the post-injury rehabilitation program. Evaluated gait analysis and functional results in patients following a designated rehabilitation program after Lisfranc injury. In this study evaluating patients with lisfranc injury treated with 3 different methods (conservative, open reduction internal fixation and primary arthrodesis), significantly reduced joint range of motion, lower walking speed and significantly lower flexion/extension of the midfoot compared to healthy subjects during the pushing phase. These changes may result from loss of muscle strength, differences in surgical methods or different rehabilitation protocols. This change during the pushing phase and the decrease in walking speed negatively affect the lives of patients functionally.
Determination of ankle mobility after injury, determination of rehabilitation effectiveness and functional evaluation will be used for the first time in our study for patients with lisfranc injury. In addition to this information, in our study, the investigators aim to evaluate functional capacity with AOFAS (American Orthopaedic Foot and Ankle Society) Midfoot Score , FAOS(Foot and Ankle Outcome Score) and heel-rise tests and be the first study in the literature to apply this test on ligamentous injury. The data obtained after the evaluation may increase the clinical use of these easy and inexpensive tests. Thus, function after Lisfranc injury can be evaluated much more easily, quickly and objectively. Lisfranc injury does not only cause deficits in muscle strength and joint range of motion. Many factors, such as long-term immobilization after injury, damage to structures rich in mechanoreceptors, or surgery, can lead to changes in both sole sensation and joint position sense.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
Fatih
-
İ̇stanbul, Fatih, Turkey, 34093
- İstanbul Tıp Fakültesi Ortopedi ve Travmatoloji Anabilimdalı
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria for Lisfranc Injury Group:
- Having had a Lisfranc injury
- Having only one extremity injured
- Having received surgical treatment
- Being over 18 years old
Exclusion Criteria for Lisfranc Injury Group :
- Having a neurological problem,
- diabetes
- smoking
- untreated Lisfranc injury
- incomplete medical record
- not wanting to participate in the study
- having a neurovascular injury
Inclusion Criteria for Healthy Volunteer Group
- Being healthy
- Any foot pain, history of fractures, etc. Absence of circumstances
- Being over 18 years of age
Exclusion Criteria for Healthy Volunteer Group
- Not being healthy
- Any foot pain, history of fractures, etc.
- Not being over 18 years of age
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
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:
|
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 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:
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Difference in plantar sensation in people with Lisfranc injuries compared to healthy people
Time Frame: 2 months
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Modified Star Excursion Test
Time Frame: 1 months
|
For balance assessment, the Modified Star Excursion Balance Test will be measured using the anterior, posteromedial and posterolateral directions.
Lower Extremity Normalization Score and Composite Score will be used for this measurement.Higher values indicate a better balance.
|
1 months
|
|
AOFAS (American Orthopaedic Foot and Ankle Society) midfoot Score
Time Frame: 1 months
|
American Orthopaedic Foot and Ankle Society (AOFAS) Midfoot Rating System range from 0 to 100, with a healthy midfoot receiving 100 points.
This score may be used to assess the intercuneiform, lateral cuneiform-cuboid, naviculocuneiform, and tarsometatarsal levels and may be useful for fractures and arthrodesis procedures.
|
1 months
|
|
FAOS (Foot and Ankle Outcome Score) Score
Time Frame: 1 months
|
Foot and Ankle Outcome Score (FAOS) subscale scores range from 0 to max , with higher scores indicating better outcomes.
A score of 100 on a subscale indicates no symptoms or limitations in that particular area, while a score of 0 indicates extreme symptoms and limitations.
|
1 months
|
Collaborators and Investigators
Investigators
- Principal Investigator: ALİ İLEZ, Istanbul Saglik Bilimleri University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- SBU-FTR-AI-02
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Lisfranc Injury
-
University of Medicine and Pharmacy at Ho Chi Minh...Unknown
-
University of CalgaryMemorial University of NewfoundlandRecruiting
-
Ostfold Hospital TrustOslo University HospitalActive, not recruiting
-
Oslo University HospitalCompleted
-
Oslo University HospitalActive, not recruitingLisfranc Injury | Foot SprainNorway
-
Inion OyRecruitingFractures, Bone | Foot Deformities | Ankle Fractures | Hallux Valgus | Hallux Rigidus | Fracture of Foot | Lisfranc Fracture | Metatarsalgia | Lisfranc Injury | Deformity, Foot | Calcaneus Fracture | Talus Fracture | Medial Malleolus Fracture | Navicular Fracture | Foot Fracture | Foot Injury | Feet Deformity Tarsus | Deformity... and other conditionsFinland
-
Maastricht University Medical CenterZonMw: The Netherlands Organisation for Health Research and DevelopmentRecruitingQuality of Life | Lisfranc Fracture | Arthrodesis | Internal FixationNetherlands
-
Rothman Institute OrthopaedicsCompletedUnstable Lisfranc Fracture-dislocations of the MidfootUnited States
-
Massachusetts General HospitalCompletedInjuries | Injury;Sports | Injury, Knee | Injury Arm | Injury Wrist | Injury, Ankle | Injury Foot | Injury, Hand | Injury Finger | Injury LegUnited States
-
University of PittsburghUnited States Department of DefenseCompletedExtremity Injury | Muscle Injury | Soft Tissue Injury | Traumatic Injury | Tendon InjuryUnited States
Clinical Trials on Assessment of the musculoskeletal system and its functions
-
University Hospital, CaenCompletedRelapsing-Remitting Multiple SclerosisFrance
-
Chang Gung Memorial HospitalNational Science Council, TaiwanUnknownUrinary Incontinence | Uterine Prolapse | Fecal IncontinenceTaiwan
-
Hopital La MusseFrench Road Safety DelegationNot yet recruitingAutism Spectrum DisordersFrance
-
Pavol Jozef Safarik UniversityUnknown
-
Sultan Abdulhamid Han Training and Research Hospital...CompletedUnrecognized ConditionTurkey
-
Tan Tock Seng HospitalNanyang Technological University; Woodlands Health CampusCompletedGastrointestinal Diseases | Esophagus Disorder | Enteral and Supplement Feeds Adverse ReactionSingapore
-
Tanta UniversityNot yet recruitingOld Age; Debility | Spinal Induced HypotensionEgypt
-
Institut PasteurHopital LariboisièreCompletedSARS-CoV-2 Acute Respiratory DiseaseFrance
-
Istanbul Kent UniversityCompletedBruxism | Sleep Quality | Muscle Stiffness | Posture | Pain AssessmentTurkey (Türkiye)
-
Centre Hospitalier Universitaire DijonNot yet recruitingMother Who Has Given Birth to a Singleton Newborn | Mother-newborn Dyad | Singleton NewbornFrance