Assessment of Balance and Function After Lateral Ankle Ligament Repair

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.

Study Overview

• Status: Unknown
• Conditions: Physical Functional Performance; Postural Balance; Complete Tear, Ankle, Lateral Ligament
• Intervention / Treatment: Other: Balance assessment; Other: Functionality assessment; Other: Performance assessment; Other: ROM assessment

• Study Type: Observational
• Enrollment (Anticipated): 30

Contacts and Locations

• Study Contact: Name: inci ayas; Phone Number: 03122162621; Email: inciayass@gmail.com
• Study Contact Backup: Name: seyit çıtaker; Phone Number: 03122162621; Email: scitaker@gazi.edu.tr

Study Locations

• Turkey
  • Ankara, Turkey, 06560
    • Recruiting
    • Inci Ayas
    • Contact: inci ayas; Phone Number: 03122162621; Email: inciayass@gmail.com
    • Contact: seyit çıtaker; Phone Number: 03122162621; Email: scitaker@gazi.edu.tr
    • Sub-Investigator: beyza yazgan dağlı

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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.

Description

Inclusion Criteria:

• Patients who have passed at least 1 year after the operation Unilateral arthroscopic ATFL repair Volunteer to participate in the study

Exclusion Criteria:

• Any orthopedic conditions, neuromuscular disease, balance disorder, cognitive disorder, history of fracture and surgical operation of the lower extremity

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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	Other: Balance assessment; 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.; Other Names: Clinical assessment; Other: Functionality assessment; Functionality will be evaluated with the Lower Extremity Functional Scale and AOFAS (American Orthopedic Foot and Ankle Society Ankle-Hindfoot Scale); Other Names: Clinical assessment; Other: Performance assessment; Performance evaluation will be made with a single leg jump test and time up and go test.; Other Names: Clinical assessment; Other: ROM assessment; Range of motion (ROM) of the ankle will be measured with an electrogonyometer in dorsi-plantar flexion.; Other Names: Clinical assessment
Control group; Between the ages of 18-65 Volunteer to participate in the study Healthy individuals with no disease	Other: Balance assessment; 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.; Other Names: Clinical assessment; Other: Functionality assessment; Functionality will be evaluated with the Lower Extremity Functional Scale and AOFAS (American Orthopedic Foot and Ankle Society Ankle-Hindfoot Scale); Other Names: Clinical assessment; Other: Performance assessment; Performance evaluation will be made with a single leg jump test and time up and go test.; Other Names: Clinical assessment; Other: ROM assessment; Range of motion (ROM) of the ankle will be measured with an electrogonyometer in dorsi-plantar flexion.; Other Names: Clinical assessment

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Jumping performance assessment	Performance evaluation will be made with a single leg jump test.	1 year postoperatively
Walking ability	Performance evaluation will be made with time up and go test.	1 year postoperatively
Lower limb functionality assessment	Functionality will be evaluated with the Lower Extremity Functional Scale.	1 year postoperatively
Foot and ankle functionality assessment	Functionality will be evaluated with the AOFAS (American Orthopedic Foot and Ankle Society Ankle-Hindfoot Scale)	1 year postoperatively
ROM assessment	Range of motion (ROM) of the ankle will be measured with an electrogonyometer in dorsi-plantar flexion.	1 year postoperatively

Collaborators and Investigators

• Sponsor: Gazi University
• Investigators: Study Director: seyit çıtaker, Gazi University

Study record dates

Study Major Dates

• Study Start (Actual): February 12, 2021
• Primary Completion (Anticipated): February 1, 2022
• Study Completion (Anticipated): February 1, 2022

Study Registration Dates

• First Submitted: February 27, 2021
• First Submitted That Met QC Criteria: March 4, 2021
• First Posted (Actual): March 9, 2021

Study Record Updates

• Last Update Posted (Actual): March 9, 2021
• Last Update Submitted That Met QC Criteria: March 4, 2021
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Keywords: Postural Balance; Physical Functional Performance; Lateral ankle ligaments repair
• Other Study ID Numbers: IAyas

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No