NCT06875596

Brief Summary

The primary objective of this study is to investigate the effectiveness of a shoulder girdle exercise program in improving stability, range of motion, and motor control in female handball players.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
22mo left

Started Mar 2025

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress40%
Mar 2025Feb 2028

First Submitted

Initial submission to the registry

March 8, 2025

Completed
Same day until next milestone

Study Start

First participant enrolled

March 8, 2025

Completed
5 days until next milestone

First Posted

Study publicly available on registry

March 13, 2025

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 10, 2025

Completed
2.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

February 10, 2028

Expected
Last Updated

January 23, 2026

Status Verified

March 1, 2025

Enrollment Period

6 months

First QC Date

March 8, 2025

Last Update Submit

January 21, 2026

Conditions

Keywords

HandballSports Performance AssessmentMuscle Strength assessmentScapularScapular dyskinesis

Outcome Measures

Primary Outcomes (3)

  • Scapulohumeral rhythm

    Scapular upward rotation is assessed with the Digital Inclinometer (BASELINE 12-1057) in a seated position to minimize compensatory movements of the trunk and lower extremities. The first measurement is taken at baseline (0° of shoulder flexion), followed by additional measurements at 30°, 60°, 90°, and 120° of shoulder flexion. Each position is held for 10-15 seconds to ensure stable measurement conditions. Measurements are repeated three times and the average is used for analysis. The assessment will be performed on both the dominant and non-dominant upper limb to evaluate movement symmetry. Data will be recorded manually by a research assistant to reduce the risk of reading errors and to ensure measurement accuracy. Statistical analysis will be performed to determine the scapulohumeral rhythm across different ranges of motion and to identify potential movement asymmetries.

    through study completion, an average of 2 years

  • ISOMETRIC STRENGTH TEST - Internal and External Rotation

    Isometric strength assessment of the shoulder girdle muscles will be conducted using the Lafayette Hand-Held Dynamometer (HHD). For the rotator muscles, measurements will be performed in the prone position with the shoulder abducted to 90° and the elbow flexed to 90°, with the forearm hanging freely over the edge of the examination table. This setup will be used for both internal and external rotation strength assessments. Results are expressed in Newtons (N) or normalized to body weight as Newtons per kilogram (N/kg).

    through study completion, an average of 2 years

  • Y-Balance Upper Quarter Test (YBT-UQ)

    The Y-Balance Upper Quarter Test (YBT-UQ) is used to assess upper extremity stability and reach performance. The test requires the participant to maintain a single-arm support position while the opposite arm performs reaching movements in three directions: anterior (forward), inferolateral (diagonally opposite the supporting hand), and superolateral (diagonally toward the supporting hand). Each reach is measured in centimeters, and the final score for each direction is calculated as the average of three trials. The test will be performed on both upper limbs and arm length will be included in the analysis to ensure standardized results. Results will be reported in centimeters, "cm", and Upper Limb Length % (standardized by upper limb length).

    through study completion, an average of 2 years

Secondary Outcomes (2)

  • RANGE OF MOTION (Shoulder Internal and External Rotation)

    through study completion, an average of 2 years

  • Closed Kinetic Chain Upper Extremity Stability Test

    through study completion, an average of 2 years

Study Arms (2)

Experimental: Handball female players

EXPERIMENTAL
Other: Experimental: Exercise Program

Control: Handball female players

ACTIVE COMPARATOR
Other: Control: Exercise Program

Interventions

The entire program begins with an assessment of scapulohumeral rhythm using a digital inclinometer, isometric strength testing, range of motion measurements, the Y-Balance Upper Quarter Test, and the Closed Kinetic Chain Upper Extremity Stability Test. The exercise program for the experimental group lasts eight weeks and is divided into four two-week phases with four sets of exercises targeting the dominant upper extremity only. After the initial assessment, participants will undergo scapular positioning correction for the dominant extremity. They are then introduced to the first set of exercises for the first two weeks. The handball players will be given an exercise sheet explaining each exercise, which they will complete daily after completing their assigned ten minutes of exercise. They will also be given two resistance bands to provide resistance during the assigned exercises. One band is for upper scapular rotation, while the other is for resisting

Also known as: Control: Handball female players
Control: Handball female players

Participants in the active control group will begin the program in the same manner as the experimental group, beginning with scapulohumeral rhythm assessments using a digital inclinometer, isometric strength testing, range of motion measurements, the Y-Balance Upper Quarter Test, and the Closed Kinetic Chain Upper Extremity Stability Test. They will also follow an eight-week exercise program divided into four two-week phases with four sets of exercises targeting the dominant upper extremity only. The key difference is that the control group will not focus on correcting scapular position for upward rotation during the exercises. Specifically, they will skip the upward rotation exercises at the beginning of each set and will not incorporate the acquired upward rotation control into other movement exercises. You will also be given a resistance band to provide resistance during the assigned exercises.

Also known as: Experimental: Handball female players Exercise Program
Experimental: Handball female players

Eligibility Criteria

Age16 Years - 45 Years
Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Healthy individuals with no reported health problems
  • No history of shoulder or elbow surgery within the past 2 years
  • Received information about the study
  • Written consent from the participant to participate in the study, including video recording and photography

You may not qualify if:

  • Injury or trauma to the upper extremity within the past 3 months
  • Illness that prevents participation in the study or tests
  • Heavy physical activity of the shoulder girdle within 2 hours prior to the study
  • Orthopedic surgery or physiotherapy treatment of the shoulder girdle

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Immunobiology and Environment Microbiology, Medical University of Gdańsk

Gdansk, Pomeranian Voivodeship, 80-211, Poland

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
Participants are not informed of the study hypothesis, which is to compare the effects of the upper scapular rotation-based exercise intervention with a standardised upper extremity exercise programme. This will ensure that participants perform to the best of their ability without bias.
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

March 8, 2025

First Posted

March 13, 2025

Study Start

March 8, 2025

Primary Completion

September 10, 2025

Study Completion (Estimated)

February 10, 2028

Last Updated

January 23, 2026

Record last verified: 2025-03

Locations