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Completed

NCT Number: NCT06459258

Throwing Velocity and Patient Reported Outcomes in Elite Level Handball Players After Completion of Shoulder-Pacemaker Strength Training

The successful application of treatment protocols using motion-triggered neuromuscular electrical stimulation (NMES) for treatment-resistant functional posterior shoulder instability was recently demonstrated. The purpose of this study is to evaluate the concept of a motion-triggered NMES training protocol through objective clinical outcome parameters and its impact on external rotational (ER) shoulder strength and throwing velocity in healthy, elite-level handball players.

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Key information

Conditions

Shoulder Dislocation Joint Diseases Joint Dislocations Musculoskeletal Diseases Shoulder Injuries Wounds and Injuries

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Sportorthopädie Zentrum

Vienna, 11190, Austria

About this study

The aim of this study is to evaluate the concept of a motion-triggered NMES training protocol through objective clinical outcome parameters and its impact on external rotational (ER) shoulder strength and throwing velocity in healthy, elite-level handball players. It is hypothesized that a 6-week motion-triggered NMES shoulder strengthening training protocol in elite-level handball players would lead to an increase in throwing velocity due to an improved motor ability and ER shoulder strength.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Elite level handball players healthy and actively competing at the time of the study
  • Patients must be at least 18 years at the time of signing the informed consent
  • Pregnancy must be ruled out in the case of female participants (e.g., pregnancy test)
  • Patient must be available for all specified assessments throughout the study duration
  • All patients are required to give written informed consent before enrollment

Exclusion criteria

  • age <18,
  • history of type I or II shoulder instability according to the Stanmore classification12,
  • existing pain syndrome (defined by pain at rest or during motion that is not caused by dislocation and impedes training),
  • recent shoulder surgery (<1 year).
  • Contraindication to SPM treatment (e.g., cardiac pacemaker)
  • Neurological disorders or nerve injuries causing the instability
  • Uncontrolled alcohol or substance abuse

Treatment and study plan

Motion-triggered NMES training protocol

Other

Experimental group subjects undergo a motion-triggered NMES shoulder strengthening training program (3x/week, 30 minutes for 6 weeks) using the Shoulder Pacemaker (NCS Lab Srl, Modena, Italy), a motion activated stimulation device to strengthen muscular disbalances. This is accomplished through varying neuromuscular electrical stimulation intensity based on the angle of motion of the arm producing subtetanic contraction and provoking supraspinal neural adaptations. Electrode placement: electrode 1, inferior to the scapular spine (infraspinatus, teres minor, + posterior deltoid); electrode 2, medial to the medial scapula border (lower trapezius + rhomboids) . Sets x repetitions: 3x20 Levels: Level 1-3; Exercise 1: L1: Supported row, L2: Front raises in 45°, L3 Front raises (thumbs up) Exercise 2: L1: Resisted front raises, L2: Crossbody resisted raises, L3: Crossbody; forehand swing; Exercise 3: L1: Rear dealt fly, L2: Single arm resisted row, L3: Underhand volleyball

Non-Motion-triggered NMES training protocol

Other

Arm Description: Subjects of the control group undergo a conventional standardized strength training program (3x/week, 30 minutes for 6 weeks) with concentric, eccentric, and functional training exercises.

Primary outcomes

  1. Throwing velocity (km*h-1)

    Time frame: Baseline to 6-week post-intervention follow-up.

    the difference in throwing velocity (km*h-1) from baseline to 6-week post-intervention follow-up.

Secondary outcomes

  1. Isometric hand-held dynamometer (HHD) ER and internal rotation (IR) maximal shoulder strength

    Time frame: Baseline to 6-week post-intervention follow-up

    Secondary outcome was the difference in isometric hand-held dynamometer (HHD) ER and internal rotation (IR) maximal shoulder strength at final follow-up.

Sponsors and collaborators

Lead sponsor

Sportorthopädie Zentrum in Wien Hietzing

Other

Collaborators

  • Austrian Research Group for Regenerative and Orthopedic Medicine

Registry information

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Jun 14, 2024
Registry last updated
Jun 14, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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