Lisfranc InjuryNCT06420856
Changes of Various Structures After Lisfranc Injury Compared to Healthy Individuals.
An observational study of Lisfranc Injury, run by Istanbul Saglik Bilimleri University at 1 site in Turkey (Türkiye).
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lisfranc Injury
- What is being tested?
- Assessment of the musculoskeletal system and its functions
- How many people
- 23 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 2 Jan 2024to 8 Jun 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
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.
Who may be able to join
- Having had a Lisfranc injury
- Having only one extremity injured
- Having received surgical treatment
- Being over 18 years old
- Being healthy
- Any foot pain, history of fractures, etc. Absence of circumstances
- Being over 18 years of age
Who cannot join
- Having a neurological problem,
- diabetes
- smoking
- untreated Lisfranc injury
- incomplete medical record
- not wanting to participate in the study
Show all 10Show fewer
- having a neurovascular injury
- Not being healthy
- Any foot pain, history of fractures, etc.
- Not being over 18 years of age
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
İstanbul Tıp Fakültesi Ortopedi ve Travmatoloji Anabilimdalı
Istanbul, Fatih, 34093
About this study
Official title: Is There a Relationship Between Protective Sole Sense, Ankle Proprioception, Ankle Mobility and Balance in Patients With Treated Lisfranc Injury?
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.
Read the 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.
- Conditions
- Lisfranc Injury
- Being tested
- Assessment of the musculoskeletal system and its functions
- Keywords
- Proprioception, Postural Balance, Foot Injuries
- Medical subject headings
- Foot Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Assessment of the musculoskeletal system and its functionsOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Other: Assessment of the musculoskeletal system and its functions |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2 months
Secondary outcomes (3)
AOFAS (American Orthopaedic Foot and Ankle Society) midfoot Score
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.
Measured: 1 months
FAOS (Foot and Ankle Outcome Score) Score
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.
Measured: 1 months
Modified Star Excursion Test
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.
Measured: 1 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2024
- Study start2 Jan 2024
- Primary completion17 May 2024
- Study completion8 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lisfranc InjuryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul Saglik Bilimleri University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ali Ilez, Istanbul Saglik Bilimleri University
- Investigators
- ALİ İLEZ, Principal investigator, Istanbul Saglik Bilimleri University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06420856
- Sponsor's protocol ID
- SBU-FTR-AI-02
- Status last verified
- Jun 2024
- First submitted
- 15 May 2024
- Last updated
- 21 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Is There a Relationship Between Protective Sole Sense, Ankle Proprioception, Ankle Mobility and Balance in Patients With Treated Lisfranc Injury?
- ClinicalTrials.gov ID
- NCT06420856
- Acronym / sponsor ID
- SBU-FTR-AI-02
- Conditions
- Lisfranc Injury
- Keywords
- Proprioception, Postural Balance, Foot Injuries
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- Istanbul Saglik Bilimleri UniversityUniversity, hospital or other
- Study start
- 2 Jan 2024 (actual)
- Primary completion
- 17 May 2024 (actual)
- Study completion
- 8 Jun 2024 (actual)
- First posted
- 20 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lisfranc injury patients | – | Other: Assessment of the musculoskeletal system and its functionsSense 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 |
| Healthy Volunteers | – | Other: Assessment of the musculoskeletal system and its functionsSense 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (7 listed)
- Having had a Lisfranc injury
- Having only one extremity injured
- Having received surgical treatment
- Being over 18 years old
- Being healthy
Key exclusion criteria (10 listed)
- Having a neurological problem,
- diabetes
- smoking
- untreated Lisfranc injury
- incomplete medical record
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Assessment of the musculoskeletal system and its functionsMeasurement 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. | Other | Healthy Volunteers, Lisfranc injury patients |
Primary outcome
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.
3 secondary outcomes
AOFAS (American Orthopaedic Foot and Ankle Society) midfoot Score
Time frame: 1 months
FAOS (Foot and Ankle Outcome Score) Score
Time frame: 1 months
Modified Star Excursion Test
Time frame: 1 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jun 2024.
- Individual participant dataSharing planned: No
Related trials for Lisfranc Injury
Recruiting
Performance and Safety Evaluation of Inion CompressOn Screw in Foot and Ankle Surgeries. PMCF Investigation
Medial Malleolus Fracture, Lisfranc Injury
Active, not recruiting
Stability and Outcomes of Non-displaced Lisfranc Injuries
Lisfranc Injury, Sprain of Foot
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
ALİ İLEZ principal investigator
Istanbul Saglik Bilimleri University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lisfranc Injury, run by Istanbul Saglik Bilimleri University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Difference in plantar sensation in people with Lisfranc injuries compared to healthy people (time frame: 2 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jun 2024.