NCT06875596

Brief Summary

This record describes a planned randomized parallel-group trial of a modified Watson-based shoulder exercise program in female handball players. An internal pilot phase was conducted first to evaluate feasibility and obtain preliminary estimates to inform the definitive trial.

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
19mo left

Started Mar 2025

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
active not recruiting

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 Progress48%
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

May 7, 2026

Status Verified

May 1, 2026

Enrollment Period

6 months

First QC Date

March 8, 2025

Last Update Submit

May 1, 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: Modified Watson-based scapular exercise program

EXPERIMENTAL

Participants undergo baseline and post-intervention assessment including scapulohumeral rhythm, range of motion, isometric shoulder strength, Upper Quarter Y-Balance Test, and Closed Kinetic Chain Upper Extremity Stability Test. The intervention lasts 8 weeks and is divided into four consecutive 2-week phases targeting the dominant upper extremity. Participants receive scapular positioning correction and scapular-specific cueing aimed at improving upward rotation and neuromuscular control during exercise performance. Two elastic resistance bands are used: one to facilitate scapular upward rotation control and one to provide external resistance during the exercises. Participants are instructed to perform the home exercise program daily for approximately 10 minutes.

Other: Modified Watson-based scapular exercise program

Active Comparator: Standard upper-limb exercise program

ACTIVE COMPARATOR

Participants undergo baseline and post-intervention assessment including scapulohumeral rhythm, range of motion, isometric shoulder strength, Upper Quarter Y-Balance Test, and Closed Kinetic Chain Upper Extremity Stability Test. The control intervention lasts 8 weeks and is divided into four consecutive 2-week phases targeting the dominant upper extremity. Participants perform a standardized upper-limb exercise program without scapular positioning correction, without scapular-specific cueing, and without specific upward-rotation facilitation. One elastic resistance band is used to provide external resistance during the exercises. Participants are instructed to perform the home exercise program daily for approximately 10 minutes.

Other: Active Comparator: Standard upper-limb exercise program

Interventions

An 8-week dominant-limb standardized upper-limb exercise program performed with one elastic resistance band and without scapular positioning correction or scapular-specific cueing.

Active Comparator: Standard upper-limb exercise program

An 8-week dominant-limb exercise program based on the Watson rehabilitation approach, incorporating scapular positioning correction, scapular-specific cueing, and progressive exercises performed with two elastic resistance bands.

Experimental: Modified Watson-based scapular exercise program

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 Officials

  • Bartosz Wilczyński

    Medical University of Gdansk

    PRINCIPAL INVESTIGATOR

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. The internal pilot phase used a pragmatic allocation procedure that differed from the definitive randomization plan.
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

May 7, 2026

Record last verified: 2026-05

Data Sharing

IPD Sharing
Will share

Data on OSF (osf.io/n9ket/)

Time Frame
Beginning upon publication and available indefinitely.
Access Criteria
Available via OSF repository without restriction.
More information

Locations