Assessment of Balance and Function After Lateral Ankle Ligament Repair

NCT ID: NCT04788225

Last Updated: 2021-03-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

30 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-02-12

Study Completion Date

2022-02-01

Brief Summary

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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.

Detailed Description

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Conditions

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

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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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

Balance assessment

Intervention Type OTHER

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

Intervention Type OTHER

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

Performance assessment

Intervention Type OTHER

Performance evaluation will be made with a single leg jump test and time up and go test.

ROM assessment

Intervention Type OTHER

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

Control group

Between the ages of 18-65 Volunteer to participate in the study Healthy individuals with no disease

Balance assessment

Intervention Type OTHER

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

Intervention Type OTHER

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

Performance assessment

Intervention Type OTHER

Performance evaluation will be made with a single leg jump test and time up and go test.

ROM assessment

Intervention Type OTHER

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

Interventions

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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.

Intervention Type OTHER

Functionality assessment

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

Intervention Type OTHER

Performance assessment

Performance evaluation will be made with a single leg jump test and time up and go test.

Intervention Type OTHER

ROM assessment

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

Intervention Type OTHER

Other Intervention Names

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Clinical assessment Clinical assessment Clinical assessment Clinical assessment

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Gazi University

OTHER

Sponsor Role lead

Responsible Party

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İnci Hazal Ayas

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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seyit çıtaker

Role: STUDY_DIRECTOR

Gazi University

Locations

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Inci Ayas

Ankara, , Turkey (Türkiye)

Site Status RECRUITING

Countries

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Turkey (Türkiye)

Central Contacts

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inci ayas

Role: CONTACT

03122162621

seyit çıtaker

Role: CONTACT

03122162621

Facility Contacts

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inci ayas

Role: primary

03122162621

seyit çıtaker

Role: backup

03122162621

Other Identifiers

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IAyas

Identifier Type: -

Identifier Source: org_study_id

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