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

NCT06459258 | Completed

• 1 other identifier: EK22-201-1022
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Shoulder Dislocation

Keywords

Motion-Triggered Neuromuscular Electrical Stimulation-Enhanced Strength Training

Outcome Measures

Primary Outcomes (1)

• Throwing velocity (km*h-1)

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

  Baseline to 6-week post-intervention follow-up.

Secondary Outcomes (1)

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

  Baseline to 6-week post-intervention follow-up

Study Arms (2)

Non-NMES control group

ACTIVE COMPARATOR

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.

Other: Non-Motion-triggered NMES training protocol

NMES group

EXPERIMENTAL

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 serve

Other: Motion-triggered NMES training protocol

Interventions

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

NMES group

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.

Non-NMES control group

Eligibility Criteria

• Age: 18 Years+
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Sportorthopädie Zentrum in Wien Hietzing: lead
• Austrian Research Group for Regenerative and Orthopedic Medicine: collaborator

Study Sites (1)

Sportorthopädie Zentrum

Vienna, 11190, Austria

Location

Related Publications (3)

• Moroder P, Karpinski K, Akgun D, Danzinger V, Gerhardt C, Patzer T, Tauber M, Wellmann M, Scheibel M, Boileau P, Lambert S, Porcellini G, Audige L. Neuromuscular Electrical Stimulation-Enhanced Physical Therapist Intervention for Functional Posterior Shoulder Instability (Type B1): A Multicenter Randomized Controlled Trial. Phys Ther. 2024 Jan 1;104(1):pzad145. doi: 10.1093/ptj/pzad145.

  PMID: 37870503 RESULT

• Moroder P, Danzinger V, Maziak N, Plachel F, Pauly S, Scheibel M, Minkus M. Characteristics of functional shoulder instability. J Shoulder Elbow Surg. 2020 Jan;29(1):68-78. doi: 10.1016/j.jse.2019.05.025. Epub 2019 Aug 1.

  PMID: 31378683 RESULT

• Moroder P, Plachel F, Van-Vliet H, Adamczewski C, Danzinger V. Shoulder-Pacemaker Treatment Concept for Posterior Positional Functional Shoulder Instability: A Prospective Clinical Trial. Am J Sports Med. 2020 Jul;48(9):2097-2104. doi: 10.1177/0363546520933841.

  PMID: 32667266 RESULT

MeSH Terms

Conditions

Shoulder Dislocation

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Study group allocation is performed in a randomized and examiner-blinded fashion. All study authors and examiners are blinded to the group allocation until completion of data analysis.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: June 10, 2024
• First Posted: June 14, 2024
• Study Start: March 1, 2023
• Primary Completion: February 7, 2024
• Study Completion: June 7, 2024
• Last Updated: June 14, 2024

Record last verified: 2024-06

Locations

AU (1)