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临床试验/NCT07146243
NCT07146243已完成不适用

Shoulder Injury Prevention in Adolescent Handball Players Based on Scandinavian Protocols: A Cluster-Randomized Controlled Trial

Semmelweis University1 个研究点 分布在 1 个国家目标入组 137 人开始时间: 2025年8月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
137
试验地点
1
主要终点
Scapular Dyskinesis Test (SDT) - classification during flexion and abduction

研究概览

简要总结

This cluster-randomised controlled trial will evaluate the effects of two internationally recognised shoulder injury prevention programmes - the Swedish Shoulder Control programme and the Norwegian Oslo Sports Trauma Research Center Shoulder Injury Prevention programme - on shoulder function, scapular control, and injury incidence in Hungarian adolescent handball players (U16-U20). Six elite-level teams (3 male, 3 female) from a single handball academy will be randomised by cluster into two intervention arms for an 18-week intervention period. Primary outcomes are changes in objective shoulder function tests; secondary outcomes include self-reported function and weekly injury monitoring.

详细描述

This study is a two-armed cluster-randomised controlled trial designed to assess the effects of two established, evidence-based shoulder injury prevention programmes in Hungarian adolescent elite handball players. Both programmes have previously demonstrated effectiveness in reducing the incidence of shoulder injuries in overhead athletes; however, it remains unclear how they compare in their ability to improve specific objective outcomes such as shoulder stability, proprioception, strength, and scapular control. The trial will be conducted at a single elite handball academy, including six teams (three male, three female) in the U16-U20 age categories. Teams will be randomised at the cluster level (team) into one of two intervention arms, each performing one of the two prevention programmes for the entire competitive half-season (18 weeks).

Unlike most injury prevention studies in adolescent athletes, this trial combines weekly self-reported monitoring of shoulder health (OSTRC-O Shoulder Module) with a comprehensive battery of objective, instrumented assessments of shoulder function, scapular control, strength, and proprioception. This dual approach allows for a more precise evaluation of programme effectiveness, capturing both perceived and measurable physical changes.

This prevention trial forms part of a larger, ongoing research programme investigating shoulder function and return-to-sport readiness following shoulder injury in overhead athletes. The same battery of objective tests (scapular dyskinesis assessment, LSST, mLSST, CKCUEST, YBT-UQ, proprioception testing, isometric strength testing) used here is also applied in the broader project, allowing the present study to generate insights that directly inform both preventive strategies and post-injury rehabilitation protocols.

The findings from this trial are expected to inform refinements of existing shoulder injury prevention protocols, enhance compliance strategies, and support sport-specific adaptations for adolescent elite handball players and other overhead athletes.

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
None

盲法说明

Due to the team-based cluster randomization and the nature of the intervention, masking of participants, coaches, and outcome assessors is not feasible. Entire teams are assigned to either the Swedish or the Norwegian shoulder injury prevention programme, making the intervention easily identifiable. The physiotherapists conducting the physical performance tests are aware of team allocation because they are also involved in the organization and supervision of the intervention sessions. However, the primary outcomes are objective, performance-based measures (e.g., CKCUEST, Y Balance Test-Upper Quarter, LSST, SDT, shoulder proprioception testing), which substantially reduces the potential risk of measurement bias.

入排标准

年龄范围
13 Years 至 19 Years(Child, Adult)
性别
All
接受健康志愿者
是

入选标准

  • •Registered competitive handball players from the participating academy team (U16, U18, U20; male and female).
  • •Age between 13 and 19 years at baseline assessment.
  • •Currently participating in regular handball training and matches (minimum 3 training sessions per week).
  • •Member of a team assigned to the intervention for the full study period.
  • •Provided written informed consent (and parental consent for participants under 18 years).

排除标准

  • •Acute shoulder injury at baseline preventing training
  • •Shoulder surgery in last 6 months
  • •Contraindication to resistance training
  • •Concurrent enrolment in another interventional study targeting the shoulder/upper limb.
  • •Refusal of informed consent (and parental consent for participants <18 years).

研究组 & 干预措施

Swedish Shoulder Control Programme

Experimental

Female U18, Male U16 and Male U20 perform the physiotherapy component of the Swedish Shoulder Control Programme, excluding the throwing block, as it is designed for the off-season and the programme is implemented during the competitive season. Sessions are supervised by two physiotherapists, performed twice per week for a total of 18 weeks, before training sessions, and last approximately 15 minutes each.

干预措施: Swedish Shoulder Control Programme (Behavioral)

Norwegian OSTRC Shoulder Injury Prevention Programme

Experimental

Female U16, Female U20 and Male U18 perform the Norwegian Shoulder Injury Prevention Programme (OSTRC). This evidence-based programme includes warm-up and strengthening exercises targeting the shoulder complex, designed to reduce the risk of shoulder injuries. Sessions are supervised by two physiotherapists, performed twice per week for a total of 18 weeks, before training sessions, and last approximately 15 minutes each.

干预措施: Norwegian OSTRC Shoulder Injury Prevention Programme (Behavioral)

结局指标

主要结局

Scapular Dyskinesis Test (SDT) - classification during flexion and abduction

时间窗: Baseline and 18 weeks

Description: Standard Kibler/McClure SDT with five consecutive repetitions of active shoulder flexion and abduction at a metronome cadence. Participants hold hand weights scaled to body mass: 1.5 kg if body mass \<68.1 kg, and 2.5 kg if ≥68.1 kg. Testing is video-recorded. Two trained assessors, rate each shoulder from the videos as none / subtle / obvious dyskinesis for each plane. Primary outcome: proportion with any dyskinesis (subtle+obvious) by plane; secondary: shift in severity category from baseline. Lower prevalence/severity indicates improvement. Rater reliability plan: Inter-rater agreement will be quantified using weighted Cohen's kappa per plane.

Change in Y Balance Test - Upper Quarter (composite reach, % limb length)

时间窗: Baseline and 18 weeks

Description: YBT-UQ performed for each arm in three directions (medial, inferolateral, superolateral), three valid trials per direction. Composite reach score = (sum of the 3 maximal reaches / limb length) × 100. Limb length = C7 to tip of middle finger. Primary score is the composite % per arm; higher is better.

Shoulder proprioception error in external and internal rotation (absolute error, degrees)

时间窗: Baseline and 18 weeks

Joint position sense was assessed in supine position using a wrist-mounted digital angle gauge. For external rotation testing, the participant actively moved the arm to their individual full external rotation in 90° abduction. The target angle was then calculated using the formula: (Full ER in degrees-90)/2+90 This yields a mid-range position between neutral and the individual's maximal external rotation. First, with eyes open, then vision was occluded using a towel, and the procedure was repeated three times per limb: the assessor passively positioned the arm at the target, returned it to vertical, and the participant attempted to reposition it to the same angle without visual feedback. The absolute repositioning error (in degrees) between the target and reproduced positions was recorded for each trial, then averaged across the three trials per limb. Internal rotation target angle calculated as: 90-(90-Full IR in degrees)/2 Lower error values indicate better proprioceptive acuity

OSTRC-O Shoulder Module severity score (0-100)

时间窗: Weekly for 18 Weeks

Weekly Oslo Sports Trauma Research Center Overuse Injury Questionnaire (4 items). Composite 0-100 severity (higher = worse). Report mean weekly severity, prevalence of any problem (non-minimum response on any item), and prevalence of substantial problem (moderate/severe reduction in training/performance or complete inability to participate), as per standard methodology.

次要结局

  • Change in CKCUEST performance (touch count)(Baseline and 18 weeks)
  • Lateral Scapular Slide Test (LSST) total asymmetry score (3 positions)(Baseline and 18 weeks)
  • Modified LSST (mLSST; 2 kg and 4 kg)(Baseline and 18 weeks)
  • Change in isometric shoulder strength - external and internal rotation(Baseline and 18 weeks)
  • Training/match exposure (minutes per week)(Weekly for 18 Weeks)
  • Programme adherence (sessions/week)(Weekly for 18 Weeks)
  • Programme compliance (perceived usefulness score)(Weekly for 18 Weeks)
  • Time-loss shoulder injury incidence (per 1,000 exposure hours) - exploratory(Up to 18 Weeks)
  • Adverse events related to prevention sessions(Up to 18 Weeks)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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