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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.

研究概览

地位

尚未招聘

详细说明

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.

研究类型

介入性

注册 (估计的)

76

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习联系方式

学习地点

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 至 50年 (成人)

接受健康志愿者

不

有资格学习的性别

全部

描述

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

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 主要用途:其他
  • 分配:不适用
  • 介入模型:单组作业
  • 屏蔽:无(打开标签)

武器和干预

参与者组/臂
干预/治疗
实验性的: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.

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Total Ankle-GO score measured at M2
大体时间:2 months

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

2 months

次要结果测量

结果测量
措施说明
大体时间
Ankle-GO score measured at M1
大体时间:1 month

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

1 month
Ankle-GO score measured at M4
大体时间:4 months

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

4 months
Return to sport at M2
大体时间:2 months

Actual return to sport assessed at month 2 (M2)

2 months
Return to sport at M4
大体时间:4 months

Actual return to sport assessed at month 4 (M4)

4 months
Time to return to sport at M2
大体时间: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
大体时间: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
大体时间: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
大体时间: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
大体时间: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

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

调查人员

  • 研究主任:Corentin Boulay Le Soleuz, Resident physician、Groupe Hospitalier de la Rochelle Ré Aunis

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (估计的)

2026年11月1日

初级完成 (估计的)

2027年9月1日

研究完成 (估计的)

2027年11月1日

研究注册日期

首次提交

2026年10月29日

首先提交符合 QC 标准的

2026年10月29日

首次发布 (实际的)

2026年11月4日

研究记录更新

最后更新发布 (实际的)

2026年11月4日

上次提交的符合 QC 标准的更新

2026年10月29日

最后验证

2026年10月1日

更多信息

与本研究相关的术语

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

是的

IPD 计划说明

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 共享时间框架

Data will be available immediately following publication

IPD 共享访问标准

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

IPD 共享支持信息类型

  • 研究方案

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

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