Construction and Validation of a Score Evaluating the Residual Instability of the Patient After Ankle Ligamentoplasty
NCT ID: NCT05331365
Last Updated: 2024-03-29
Study Results
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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COMPLETED
NA
130 participants
INTERVENTIONAL
2022-05-12
2023-03-01
Brief Summary
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The main hypothesis of this study is based on the fact that the composite score "Ankle Go Test" would allow a global validation of all the criteria of scores of 4 tests and 2 questionnaires, which are performed in common pratice, evaluating the instability of the ankle after an ankle ligamentoplasty.
Participants will have to complete 2 questionnaires (FAAM, ALR RS) and to undergoe 4 tests (Single Leg Stance Test, Side Hop Test, Start Excursion Balance Test, La figure of 8), at 4, 6 and 12 months post surgery.
Researchers will compare the group of participants who undergone ankle's ligamentoplasty with a group of healthy volunteers to assess the discriminant validity of the Ankle Go Test score
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
Healthy volunteers will be selected on a voluntary basis at the request of the investigators in the population of patients undergoing rehabilitation by physiotherapists at the investigation sites and with no history of knee or ankle problems.
DIAGNOSTIC
NONE
Study Groups
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Group of the construction of the composite Ankle go score and internal validations
50 patients will be include for the construction of the composite score and its internal validations. They will complete questionnaires (FAAM, ALR-RSI) and undergo tests (SLSTS, SHTS, SEBT and Figure of 8) 4 months after ankle's surgery (visit 1), 6 months after surgery (visit 2) and 12 months post surgery
Construction and evaluation of a composite score evaluating post ankle surgery residual instability by completing questionnaires and undergoing physical tests
Four tests and two questionnaires, each evaluating specific physical or psychological dimensions will be used to construct the composite score "Ankle Go Test" composite score:
* Foot and Ankle Ability Measure Questionnaire (FAAM)
* Ankle ligament reconstruction-return to sport after injury Questionnaire(ALR-RSI)
* Single Leg Stance Test (SLST)
* Side Hop Test (SHT)
* Star Excursion Balance Test (SEBT)
* Figure-of-8
group of the external validation stage of the composite score
50 additional patients for the external validation stage of the composite score. They will complete questionnaires (FAAM, ALR-RSI) and undergo tests (SLSTS, SHTS, SEBT and Figure of 8) 4 months after ankle's surgery (visit 1) and 6 months after surgery (visit 2)
Construction and evaluation of a composite score evaluating post ankle surgery residual instability by completing questionnaires and undergoing physical tests
Four tests and two questionnaires, each evaluating specific physical or psychological dimensions will be used to construct the composite score "Ankle Go Test" composite score:
* Foot and Ankle Ability Measure Questionnaire (FAAM)
* Ankle ligament reconstruction-return to sport after injury Questionnaire(ALR-RSI)
* Single Leg Stance Test (SLST)
* Side Hop Test (SHT)
* Star Excursion Balance Test (SEBT)
* Figure-of-8
Group allowing the assessment of the score's ability to discriminate
30 healthy volunteers (who did not undergone an ankle's surgery) will be included in the study to analyze the ability of composite score to discriminate. The healthy population will perform the same physical and psychological tests as Group allowing the construction of the composite Ankle go score and internal validations
No interventions assigned to this group
Interventions
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Construction and evaluation of a composite score evaluating post ankle surgery residual instability by completing questionnaires and undergoing physical tests
Four tests and two questionnaires, each evaluating specific physical or psychological dimensions will be used to construct the composite score "Ankle Go Test" composite score:
* Foot and Ankle Ability Measure Questionnaire (FAAM)
* Ankle ligament reconstruction-return to sport after injury Questionnaire(ALR-RSI)
* Single Leg Stance Test (SLST)
* Side Hop Test (SHT)
* Star Excursion Balance Test (SEBT)
* Figure-of-8
Eligibility Criteria
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Inclusion Criteria
2. Age ≥ 18 years
3. Patients who's been informed about the study and who didn't express their opposition to participate
Exclusion Criteria
2. Patients under legal protection
18 Years
ALL
Yes
Sponsors
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Elsan
OTHER
Responsible Party
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Locations
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Santé Atlantique
Nantes, , France
Countries
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References
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Lopes R, Andrieu M, Cordier G, Molinier F, Benoist J, Colin F, Thes A, Elkaim M, Boniface O, Guillo S, Bauer T; French Arthroscopic Society. Arthroscopic treatment of chronic ankle instability: Prospective study of outcomes in 286 patients. Orthop Traumatol Surg Res. 2018 Dec;104(8S):S199-S205. doi: 10.1016/j.otsr.2018.09.005. Epub 2018 Sep 21.
Lopes R, Noailles T, Brulefert K, Geffroy L, Decante C. Anatomic validation of the lateral malleolus as a cutaneous marker for the distal insertion of the calcaneofibular ligament. Knee Surg Sports Traumatol Arthrosc. 2018 Mar;26(3):869-874. doi: 10.1007/s00167-016-4250-7. Epub 2016 Aug 6.
Jure D, Blache Y, Degot M, Vigne G, Nove-Josserand L, Godeneche A, Collotte P, Franger G, Borel F, Rogowski I, Neyton L. The S-STARTS Test: Validation of a Composite Test for the Assessment of Readiness to Return to Sport After Shoulder Stabilization Surgery. Sports Health. 2022 Mar-Apr;14(2):254-261. doi: 10.1177/19417381211004107. Epub 2021 Apr 9.
Blakeney WG, Ouanezar H, Rogowski I, Vigne G, Guen ML, Fayard JM, Thaunat M, Chambat P, Sonnery-Cottet B. Validation of a Composite Test for Assessment of Readiness for Return to Sports After Anterior Cruciate Ligament Reconstruction: The K-STARTS Test. Sports Health. 2018 Nov/Dec;10(6):515-522. doi: 10.1177/1941738118786454. Epub 2018 Jul 19.
Carcia CR, Martin RL, Drouin JM. Validity of the Foot and Ankle Ability Measure in athletes with chronic ankle instability. J Athl Train. 2008 Apr-Jun;43(2):179-83. doi: 10.4085/1062-6050-43.2.179.
Borloz S, Crevoisier X, Deriaz O, Ballabeni P, Martin RL, Luthi F. Evidence for validity and reliability of a French version of the FAAM. BMC Musculoskelet Disord. 2011 Feb 8;12:40. doi: 10.1186/1471-2474-12-40.
Docherty CL, Arnold BL, Gansneder BM, Hurwitz S, Gieck J. Functional-Performance Deficits in Volunteers With Functional Ankle Instability. J Athl Train. 2005 Mar;40(1):30-34.
Franck F, Saithna A, Vieira TD, Pioger C, Vigne G, Le Guen M, Rogowski I, Fayard JM, Thaunat M, Sonnery-Cottet B. Return to Sport Composite Test After Anterior Cruciate Ligament Reconstruction (K-STARTS): Factors Affecting Return to Sport Test Score in a Retrospective Analysis of 676 Patients. Sports Health. 2021 Jul-Aug;13(4):364-372. doi: 10.1177/1941738120978240. Epub 2021 Feb 6.
Gribble PA, Delahunt E, Bleakley C, Caulfield B, Docherty CL, Fourchet F, Fong D, Hertel J, Hiller C, Kaminski TW, McKeon PO, Refshauge KM, van der Wees P, Vicenzino B, Wikstrom EA. Selection criteria for patients with chronic ankle instability in controlled research: a position statement of the International Ankle Consortium. J Orthop Sports Phys Ther. 2013 Aug;43(8):585-91. doi: 10.2519/jospt.2013.0303. Epub 2013 Jul 31.
Martin RL, Irrgang JJ, Burdett RG, Conti SF, Van Swearingen JM. Evidence of validity for the Foot and Ankle Ability Measure (FAAM). Foot Ankle Int. 2005 Nov;26(11):968-83. doi: 10.1177/107110070502601113.
Rosen AB, Needle AR, Ko J. Ability of Functional Performance Tests to Identify Individuals With Chronic Ankle Instability: A Systematic Review With Meta-Analysis. Clin J Sport Med. 2019 Nov;29(6):509-522. doi: 10.1097/JSM.0000000000000535.
Sigonney F, Lopes R, Bouche PA, Kierszbaum E, Moslemi A, Anract P, Stein A, Hardy A. The ankle ligament reconstruction-return to sport after injury (ALR-RSI) is a valid and reproducible scale to quantify psychological readiness before returning to sport after ankle ligament reconstruction. Knee Surg Sports Traumatol Arthrosc. 2020 Dec;28(12):4003-4010. doi: 10.1007/s00167-020-06020-6. Epub 2020 Apr 30.
Other Identifiers
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2021-A03239-32
Identifier Type: OTHER
Identifier Source: secondary_id
Ankle Go study
Identifier Type: -
Identifier Source: org_study_id
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