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Functional Recovery After a Recent Lateral Ankle Sprain With Early Initiation of Rehabilitation: Changes in the Ankle-GO Score and Its Association With Return to Sport and Recurrent Sprains. (ASGO)

2026年10月29日 更新者:Groupe Hospitalier de la Rochelle Ré Aunis

Functional Recovery After a Recent Lateral Ankle Sprain With Early Initiation of Rehabilitation: Changes in the Ankle-GO Score and Its Association With Return to Sport and Recurrent Sprains: ASGO Study

Lateral ankle sprains are common musculoskeletal injuries, particularly among young adults and athletes. Although recovery is often favorable, lateral ankle sprains may be associated with persistent pain, chronic ankle instability, delayed return to sport, and an increased risk of recurrence. The Ankle-GO score is a recently developed tool for assessing functional recovery after a lateral ankle sprain. Available data mainly concern assessments performed from the second month after injury onward. To our knowledge, changes in this score during the early recovery phase have not yet been evaluated. The ASGO study aims to describe changes in the Ankle-GO score in patients enrolled early after a lateral ankle sprain and followed for four months.

調査の概要

状態

まだ募集していません

条件

介入・治療

詳細な説明

Lateral ankle sprains are among the most common musculoskeletal injuries in young adults and athletes. Although often considered minor injuries, they can result in substantial morbidity, including persistent pain, functional limitations, reduced physical activity levels, and frequent recurrences.

The literature indicates that a substantial proportion of patients experience persistent symptoms after an initial lateral ankle sprain, and approximately 20% to 40% develop chronic ankle instability. Return to sport after an ankle sprain remains insufficiently standardized and is still frequently based on time-based or subjective criteria, despite the recent emergence of international recommendations based on clinical, functional, and psychological criteria.

Current recommendations favor early functional management, including limiting immobilization, progressively resuming weight-bearing, implementing an appropriate rehabilitation program, and applying the principles of the PEACE & LOVE protocol. Despite these recommendations, management practices remain heterogeneous in primary care and emergency departments.

To improve the assessment of functional recovery after a lateral ankle sprain, researchers have developed and subsequently validated the Ankle-GO score. This tool combines several functional tests and validated questionnaires to assess the physical and psychological dimensions of recovery, as well as readiness to return to sport.

Studies have shown that a low Ankle-GO score measured two months after a lateral ankle sprain is associated with delayed return to sport, an increased risk of recurrence, and a lower likelihood of complete functional recovery. These studies primarily assessed patients from the second month after injury onward.

To the investigator's knowledge, no study has specifically described changes in the Ankle-GO score in patients enrolled within the first few days after a sprain or investigated the potential value of assessment during the first month of follow-up.

Furthermore, several studies suggest that delayed initiation of rehabilitation may be associated with an increased risk of recurrence and less favorable functional recovery. To investigate this early recovery phase and document the actual time to rehabilitation initiation, only patients enrolled within seven days of injury will be included.

The ASGO study builds on the work of a reseracher by investigating a population enrolled within seven days of injury, a period during which early initiation of rehabilitation may influence functional recovery and the risk of recurrence.

The investigator's hypothesis is that early management following a lateral ankle sprain, combined with early initiation of functional rehabilitation after injury, is associated with better functional recovery, as assessed by the Ankle-GO score at two months.

Investigator also hypothesize that a higher Ankle-GO score at one month may be associated with a faster return to sport and a lower risk of recurrence during follow-up. This hypothesis is based on the findings of a researcher, who showed that a higher Ankle-GO score at two months was associated with better return-to-sport outcomes and a reduced risk of recurrence following a lateral ankle sprain.

研究の種類

介入

入学 (推定)

76

段階

  • 適用できない

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究連絡先

研究場所

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

18年~50年 (大人)

健康ボランティアの受け入れ

いいえ

受講資格のある性別

全て

説明

Inclusion Criteria:

  1. . Criteria related to the study population

    • Male or female aged 18 to 50 years, inclusive
    • Affiliated with a social security system
    • Sufficient understanding of French to understand the information sheet and complete the questionnaires
    • Free, informed, and signed consent provided by the participant and the investigator (no later than the day of enrollment and before any examination required for the clinical research), following oral and written information
    • Ability to complete all follow-up assessments planned in the study protocol
  2. . Criteria related to the condition under study

    • Recent lateral ankle sprain clinically diagnosed by a physician
    • Sprain occurring within the 7 days preceding enrollment
    • Initial management provided at one of the participating centers
  3. . Criteria related to sports participation

    • Regular participation in a sporting activity before the injury, defined as at least one session per week during the three months preceding the sprain
    • Willingness to return to sport

Exclusion Criteria:

  1. . Criteria related to the study population

    - Patients under 18 years of age or over 50 years of age

  2. . Criteria related to the condition under study

    • Clinically or radiologically confirmed associated fracture
    • Ankle sprain requiring prolonged strict immobilization
    • Suspected or diagnosed severe syndesmotic injury requiring specific management
    • Suspected or diagnosed Chopart or Lisfranc injury
    • Initial indication for surgery
    • Sprain of the same ankle within the six months preceding enrollment
    • Known chronic ankle instability
  3. . Criteria related to medical history

    - History of surgery or fracture involving the affected ankle

  4. . Criteria related to associated conditions

    • Neurological disorder likely to impair balance or motor control
    • Known condition affecting balance
    • Concomitant musculoskeletal injury of the lower limb likely to limit performance of functional tests
  5. . Criteria related to follow-up

    • Anticipated inability to complete the follow-up assessments planned in the study protocol
    • Refusal to participate in the study

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか?

デザインの詳細

  • 主な目的:他の
  • 割り当て:なし
  • 介入モデル:単一グループの割り当て
  • マスキング:なし(オープンラベル)

武器と介入

参加者グループ / アーム
介入・治療
実験的:Experimental group

Participants will be enrolled within seven days of a recent lateral ankle sprain and followed for four months, with a telephone call on day 10 and follow-up visits (Ankle-GO test and questionnaires) at months 1, 2, and 4.

After enrollment, a telephone call will be conducted on day 10, followed by follow-up visits (Ankle-GO test and questionnaires) at months 1, 2, and 4.

この研究は何を測定していますか?

主要な結果の測定

結果測定
メジャーの説明
時間枠
Total Ankle-GO score measured at M2
時間枠:2 months

Total Ankle-GO score measured two months (M2) after the lateral ankle sprain

2 months

二次結果の測定

結果測定
メジャーの説明
時間枠
Ankle-GO score measured at M1
時間枠:1 month

Ankle-GO score measured at month 1 (M1) after the lateral ankle sprain.

1 month
Ankle-GO score measured at M4
時間枠:4 months

Ankle-GO score measured at month 4 (M4) after the lateral ankle sprain.

4 months
Return to sport at M2
時間枠:2 months

Actual return to sport assessed at month 2 (M2)

2 months
Return to sport at M4
時間枠:4 months

Actual return to sport assessed at month 4 (M4)

4 months
Time to return to sport at M2
時間枠:2 months

Time to return to sport, expressed as the number of days between the date of injury and the first return to sport measured at month 2 (M2)

2 months
Time to return to sport at M4
時間枠:4 months

Time to return to sport, expressed as the number of days between the date of injury and the first return to sport measured at month 4 (M4)

4 months
Level of return to sport at M2
時間枠:2 months

Level of return to sport, compared with the self-reported pre-injury sports level (same or lower level) measured at month 2 (M2)

2 months
Level of return to sport at M4
時間枠:4 months

Level of return to sport, compared with the self-reported pre-injury sports level (same or lower level) measured at month 4 (M4)

4 months
Occurrence of a recurrent lateral ankle sprain
時間枠:4 months

Occurrence of a recurrent lateral ankle sprain affecting the initially injured ankle between enrollment (day 0) and the end of follow-up (month 4)

4 months

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

スポンサー

捜査官

  • スタディディレクター:Corentin Boulay Le Soleuz, Resident physician、Groupe Hospitalier de la Rochelle Ré Aunis

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始 (推定)

2026年11月1日

一次修了 (推定)

2027年9月1日

研究の完了 (推定)

2027年11月1日

試験登録日

最初に提出

2026年10月29日

QC基準を満たした最初の提出物

2026年10月29日

最初の投稿 (実際)

2026年11月4日

学習記録の更新

投稿された最後の更新 (実際)

2026年11月4日

QC基準を満たした最後の更新が送信されました

2026年10月29日

最終確認日

2026年10月1日

詳しくは

本研究に関する用語

その他の研究ID番号

  • P04051
  • 2026-A01644-47 (その他の識別子:ANSM)

個々の参加者データ (IPD) の計画

個々の参加者データ (IPD) を共有する予定はありますか?

はい

IPD プランの説明

Data will be made available with publication. A Digital Object Identifier will be used and Data will be available at www.recherche.data.gouv.fr

IPD 共有時間枠

Data will be available immediately following publication

IPD 共有アクセス基準

Researchers who provide a methodologically sound proposal will have access to the data

IPD 共有サポート情報タイプ

  • STUDY_PROTOCOL

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米国FDA規制医薬品の研究

いいえ

米国FDA規制機器製品の研究

いいえ

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