Assessment of Balance and Function After Lateral Ankle Ligament Repair

Postural Balance Clinical Trial

Official title:

Assessment of Balance and Function After Lateral Ankle Ligament Repair

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04788225
• Other study ID #: IAyas
• Status: Recruiting
• Start date: February 12, 2021
• Est. completion date: February 1, 2022

Study information

• Verified date: March 2021
• Source: Gazi University
• Contact: inci ayas
• Phone: 03122162621
• Email: inciayass[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: February 1, 2022
• Est. primary completion date: February 1, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Complete Tear, Ankle, Lateral Ligament
• Physical Functional Performance
• Postural Balance

Intervention

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.
• Functionality assessment
Functionality will be evaluated with the Lower Extremity Functional Scale and AOFAS (American Orthopedic Foot and Ankle Society Ankle-Hindfoot Scale)
• Performance assessment
Performance evaluation will be made with a single leg jump test and time up and go test.
• ROM assessment
Range of motion (ROM) of the ankle will be measured with an electrogonyometer in dorsi-plantar flexion.

Locations

Country	Name	City	State
Turkey	Inci Ayas	Ankara

Sponsors (1)

Lead Sponsor	Collaborator
Gazi University

Country where clinical trial is conducted

Turkey, 

Outcome

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