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

NCT ID: NCT06459258

Last Updated: 2024-06-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 14 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-03-01
• Study Completion Date: 2024-06-07

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.

Detailed Description

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.

Conditions

Shoulder Dislocation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

Non-NMES control group

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.

Group Type: ACTIVE_COMPARATOR

Non-Motion-triggered NMES training protocol

Intervention Type: 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.

NMES group

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

Group Type: EXPERIMENTAL

Motion-triggered NMES training protocol

Intervention Type: 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

Interventions

Motion-triggered NMES training protocol

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

Intervention Type: OTHER

Non-Motion-triggered NMES training protocol

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.

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Austrian Research Group for Regenerative and Orthopedic Medicine

OTHER

Sponsor Role: collaborator

Sportorthopädie Zentrum in Wien Hietzing

OTHER

Sponsor Role: lead

Responsible Party

Sebastian Rilk

MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Sportorthopädie Zentrum

Vienna, , Austria

Countries

Austria

References

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.

Reference Type: RESULT

PMID: 37870503 (View on PubMed)

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.

Reference Type: RESULT

PMID: 31378683 (View on PubMed)

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.

Reference Type: RESULT

PMID: 32667266 (View on PubMed)

Other Identifiers

EK22-201-1022

Identifier Type: OTHER

Identifier Source: secondary_id

EK22-201-1022

Identifier Type: -

Identifier Source: org_study_id