Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT06420856 |
| Other study ID # |
SBU-FTR-AI-02 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
January 2, 2024 |
| Est. completion date |
June 8, 2024 |
Study information
| Verified date |
June 2024 |
| Source |
Istanbul Saglik Bilimleri University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical 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 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.
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.
