A Randomized Pilot Trial to Evaluate the Preliminary Effect and Safety of Using Spraino® to Prevent Lateral Ankle Sprains in Indoor Sports (The Spraino Pilot Trial)
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 510
- 试验地点
- 2
- 主要终点
- Severe first-time non-contact lateral ankle sprains
研究概览
简要总结
This pilot study will establish the preliminary effect and safety of using Spraino® to prevent lateral ankle sprains amongst athletes competing in indoor sports at sub-elite level, with a one-year follow-up.
All recruited participants will have a history of lateral ankle sprain in the preceding 24 months prior to the initiation of the trial. Half of the included participants will receive Spraino® to prevent lateral ankle sprains (intervention group). The other half will receive no intervention ("do-as-usual" control group). Both groups will be permitted to continue or initiate any usual care of their choice, except Spraino® in the control group. Short Message Services (SMS) will be used for registration of injury and exposure.
详细描述
The purpose of this exploratory trial (named "The Spraino Pilot Trial") is to establish the preliminary effect and safety of using Spraino® to prevent lateral ankle sprains amongst athletes competing in indoor sports at sub-elite level (handball, basketball, floorball and badminton) when compared to a "do-as-usual" control group.
It is a randomized controlled pilot trial (Pilot-RCT) with a two-group parallel design and blinded outcome assessment. The trial will include prospective injury and exposure registration using a Short Message Services-system (SMS-Track) throughout a 52-week follow-up period (one calendar year).
It is anticipated that 500 participants, which approximates to 250 in each group, will be enrolled in the trial. The enrollment process will cease when at least 250 participants have been allocated to the intervention group. Only athletes participating in indoor sports with a history of a lateral ankle sprain in the preceding 24 months are eligible for inclusion in the trial. The participants will be randomized (1:1 allocation ratio) using numbered lots. The randomization process will ensure stratification for gender, sports discipline and level of play.
A full trial protocol, based on the "SPIRIT 2013 explanation and elaboration: guidance for protocols of clinical trials" (Chan et al., 2013) and the "PREPARE Trial guide" (Bandholm et al., 2017), will be published and made publicly available. The trial report will adhere to the CONSORT 2010 statement, using the extension for randomized pilot and feasibility trials.
Being an exploratory pilot trial, the study is designed with a flat outcome structure with multiple evenly valued outcome measures. Thus, no primary and secondary outcome measure hierarchy exists.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Participant is ≥ 18 years old at commencement of trial.
- •Participant can read, speak and understand Danish.
- •Participant can receive and reply to texts on a cell phone using Short Message Services (SMS).
- •Participant performs indoor sports (Handball, basketball, floorball orbadminton) in a sub-elite level team with ≥ 2 weekly practice sessions.
- •Participant has incurred ≥ 1 lateral ankle sprain injury in the preceding 24 months.
- •Participant has returned to play at commencement of the trial.
排除标准
- 未提供
研究组 & 干预措施
Intervention
Participants allocated to the intervention group will use Spraino® as a measure to prevent lateral ankle sprains.
干预措施: Spraino (Device)
Control
Participants allocated to the control group will be a "do-as-usual" comparator. This implies, that the participants can treat and prevent lateral ankle sprains in any way they wish, except using Spraino®.
结局指标
主要结局
Severe first-time non-contact lateral ankle sprains
时间窗: 52 weeks
Rate of severe first-time non-contact lateral ankle sprains (continuous) The incidence rate is defined as the number of severe first-time non-contact lateral ankle sprains (≥ 3 weeks with time-loss) per 1000 hours of exposure.
Recurrent non-contact lateral ankle sprains
时间窗: 52 weeks
Rate of recurrent non-contact lateral ankle sprains (continuous) The incidence rate is defined as the number of recurrent non-contact lateral ankle sprains per 1000 hours of exposure.
Time-loss due to first-time lateral ankle sprains
时间窗: 52 weeks
Time-loss (in number of weeks) due to first-time lateral ankle sprains per athlete (continuous)
First-time non-contact lateral ankle sprains
时间窗: 52 weeks
Rate of first-time non-contact lateral ankle sprains (continuous) The incidence rate is defined as the number of first-time non-contact lateral ankle sprains per 1000 hours of exposure.
Severe first-time lateral ankle sprains
时间窗: 52 weeks
Rate of severe first-time lateral ankle sprains (continuous) The incidence rate is defined as the number of severe first-time lateral ankle sprains (≥ 3 weeks with time-loss) per 1000 hours of exposure.
Time-loss due to recurrent non-contact lateral ankle sprains
时间窗: 52 weeks
Time-loss (in number of weeks) due to recurrent non-contact lateral ankle sprains per athlete (continuous)
Time-loss due to recurrent lateral ankle sprains
时间窗: 52 weeks
Time-loss (in number of weeks) due to recurrent lateral ankle sprains per athlete (continuous)
Severe recurrent lateral ankle sprains
时间窗: 52 weeks
Rate of severe recurrent lateral ankle sprains (continuous) The incidence rate is defined as the number of severe recurrent lateral ankle sprains (≥ 3 weeks with time-loss) per 1000 hours of exposure.
Lateral ankle sprains
时间窗: 52 weeks
Rate of lateral ankle sprains (continuous) The incidence rate is defined as the number of lateral ankle sprains per 1000 hours of exposure.
Time-loss due to first-time non-contact lateral ankle sprains
时间窗: 52 weeks
Time-loss (in number of weeks) due to first-time non-contact lateral ankle sprains per athlete (continuous)
First-time lateral ankle sprains
时间窗: 52 weeks
Rate of first-time lateral ankle sprains (continuous) The incidence rate is defined as the summation of both contact and non-contact first-time lateral ankle sprains per 1000 hours of exposure.
Recurrent lateral ankle sprains
时间窗: 52 weeks
Rate of recurrent lateral ankle sprains (continuous) The incidence rate is defined as the summation of both contact and non-contact recurrent lateral ankle sprains per 1000 hours of exposure.
Severe recurrent non-contact lateral ankle sprains
时间窗: 52 weeks
Rate of severe recurrent non-contact lateral ankle sprains (continuous) The incidence rate is defined as the number of severe recurrent non-contact lateral ankle sprains (≥ 3 weeks with time-loss) per 1000 hours of exposure.
次要结局
未报告次要终点