Assessment of Balance and Function After Lateral Ankle Ligament Repair
1 other identifier
observational
30
1 country
1
Brief Summary
Approximately 85% of ankle injuries are lateral region injuries.Surgical repair of lateral ligaments is indicated if there is more than 20 degrees of varus or more than 15 mm translation, if conservative treatment is ineffective and degree of damage is high and chronic instability has developed.After the surgery in addition to pain and edema control, weight transfer is not performed on the ankle for 6 weeks.Therefore, this process may adversely affect the muscle strength and range of motion of the ankle, and lower extremity performance and muscular synergies of balance.Although pathological changes caused by ligament damage have been investigated very well in the literature, it is not clear how surgical repair affects these changes. In our study we aim to investigate post-surgical changes. Primary aim of the study is to evaluate the balance parameters of individuals who have undergone anterior talofibular ligament and / or calcaneofibular ligament repair, and its secondary purpose is to evaluate lower extremity performance, ankle functionality, pain, range of motion and muscle strength and compare them with healthy individuals. Our hypothesis is that the balance, lower extremity performance and functionality, pain, range of motion and muscle strength of patients who have undergone ankle lateral ligament repair are worse than healthy individuals.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Feb 2021
Shorter than P25 for all trials
1 active site
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
February 12, 2021
CompletedFirst Submitted
Initial submission to the registry
February 27, 2021
CompletedFirst Posted
Study publicly available on registry
March 9, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2022
CompletedMarch 9, 2021
March 1, 2021
12 months
February 27, 2021
March 4, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (4)
Static balance assessment-Postural Stability Test
Postural Stability will be measured with the Biodex-BioSway 950-462 static balance device in single foot stance and double foot stance.
1 year postoperatively
Static balance assessment-Stability Limit Test
Stability Limit will be measured with the Biodex-BioSway 950-462 static balance device in double foot stance.
1 year postoperatively
Static balance assessment-Modified Sensori Organization Test
Modified Sensori Organization will be measured with the Biodex-BioSway 950-462 static balance device in double foot stance.
1 year postoperatively
Dynamic balance assessment
Dynamic balances will be evaluated with the Y balance test.
1 year postoperatively
Secondary Outcomes (5)
Jumping performance assessment
1 year postoperatively
Walking ability
1 year postoperatively
Lower limb functionality assessment
1 year postoperatively
Foot and ankle functionality assessment
1 year postoperatively
ROM assessment
1 year postoperatively
Study Arms (2)
Patients with ATFL repair by arthroscopic method
Patients who have passed at least 1 year after the operation Unilateral arthroscopic ATFL repair Between the ages of 18-65 Volunteer to participate in the study Without any orthopedic conditions, neuromuscular disease, balance disorder, cognitive disorder No history of fracture and surgical operation of the lower extremity
Control group
Between the ages of 18-65 Volunteer to participate in the study Healthy individuals with no disease
Interventions
Static balances will be measured with the Biodex-BioSway 950-462 static balance device according to 3 different standard test procedures (Postural Stability Test, Stability Limit Test and Modified Sensori Organization Test) in single foot stance and double foot stance. Dynamic balances will be evaluated with the Y balance test.
Functionality will be evaluated with the Lower Extremity Functional Scale and AOFAS (American Orthopedic Foot and Ankle Society Ankle-Hindfoot Scale)
Performance evaluation will be made with a single leg jump test and time up and go test.
Range of motion (ROM) of the ankle will be measured with an electrogonyometer in dorsi-plantar flexion.
Eligibility Criteria
Patients who have undergone ATFL repair surgery at Gazi University Hospital The healthy control group will consist of patient relatives or volunteers to participate in the study.
You may qualify if:
- Patients who have passed at least 1 year after the operation Unilateral arthroscopic ATFL repair Volunteer to participate in the study
You may not qualify if:
- Any orthopedic conditions, neuromuscular disease, balance disorder, cognitive disorder, history of fracture and surgical operation of the lower extremity
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Gazi Universitylead
Study Sites (1)
Inci Ayas
Ankara, 06560, Turkey (Türkiye)
Study Officials
- STUDY DIRECTOR
seyit çıtaker
Gazi University
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
February 27, 2021
First Posted
March 9, 2021
Study Start
February 12, 2021
Primary Completion
February 1, 2022
Study Completion
February 1, 2022
Last Updated
March 9, 2021
Record last verified: 2021-03