Assessment of Balance and Function After Lateral Ankle Ligament Repair

Sponsor
Gazi University (Other)
Overall Status
Recruiting
CT.gov ID
NCT04788225
Collaborator
(none)
30
1
11.6
2.6

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Balance assessment
  • Other: Functionality assessment
  • Other: Performance assessment
  • Other: ROM assessment

Study Design

Study Type:
Observational
Anticipated Enrollment :
30 participants
Observational Model:
Case-Control
Time Perspective:
Prospective
Official Title:
Assessment of Balance and Function After Lateral Ankle Ligament Repair
Actual Study Start Date :
Feb 12, 2021
Anticipated Primary Completion Date :
Feb 1, 2022
Anticipated Study Completion Date :
Feb 1, 2022

Arms and Interventions

Arm 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
  • Outcome Measures

    Primary Outcome Measures

    1. Static balance assessment-Postural Stability Test [1 year postoperatively]

      Postural Stability will be measured with the Biodex-BioSway 950-462 static balance device in single foot stance and double foot stance.

    2. Static balance assessment-Stability Limit Test [1 year postoperatively]

      Stability Limit will be measured with the Biodex-BioSway 950-462 static balance device in double foot stance.

    3. Static balance assessment-Modified Sensori Organization Test [1 year postoperatively]

      Modified Sensori Organization will be measured with the Biodex-BioSway 950-462 static balance device in double foot stance.

    4. Dynamic balance assessment [1 year postoperatively]

      Dynamic balances will be evaluated with the Y balance test.

    Secondary Outcome Measures

    1. Jumping performance assessment [1 year postoperatively]

      Performance evaluation will be made with a single leg jump test.

    2. Walking ability [1 year postoperatively]

      Performance evaluation will be made with time up and go test.

    3. Lower limb functionality assessment [1 year postoperatively]

      Functionality will be evaluated with the Lower Extremity Functional Scale.

    4. Foot and ankle functionality assessment [1 year postoperatively]

      Functionality will be evaluated with the AOFAS (American Orthopedic Foot and Ankle Society Ankle-Hindfoot Scale)

    5. ROM assessment [1 year postoperatively]

      Range of motion (ROM) of the ankle will be measured with an electrogonyometer in dorsi-plantar flexion.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 65 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Inci Ayas Ankara Turkey 06560

    Sponsors and Collaborators

    • Gazi University

    Investigators

    • Study Director: seyit çıtaker, Gazi University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    İnci Hazal Ayas, Principal Investigator, Gazi University
    ClinicalTrials.gov Identifier:
    NCT04788225
    Other Study ID Numbers:
    • IAyas
    First Posted:
    Mar 9, 2021
    Last Update Posted:
    Mar 9, 2021
    Last Verified:
    Mar 1, 2021
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by İnci Hazal Ayas, Principal Investigator, Gazi University

    Study Results

    No Results Posted as of Mar 9, 2021