NCT06923930

Brief Summary

The goal of this study is to find out if a tool called an external cueing device (ECD) can help young swimmers improve their shoulder function. An ECD is a tool that limits arm movement and gives the swimmer a target to focus on while doing exercises. The main questions this study will answer are:

  • Does using an ECD during certain exercises improve muscle strength?
  • Does using an ECD while exercising help with shoulder stability? Participants will:
  • Test their shoulder muscle strength and stability at the beginning of the study.
  • Complete 8 exercises as part of their regular dry-land training program for 6 weeks.
  • Repeat the same tests after 3 weeks and again at the end of the study.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
36

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

First Submitted

Initial submission to the registry

March 29, 2025

Completed
13 days until next milestone

First Posted

Study publicly available on registry

April 11, 2025

Completed
9 days until next milestone

Study Start

First participant enrolled

April 20, 2025

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 25, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 25, 2025

Completed
Last Updated

April 13, 2026

Status Verified

April 1, 2026

Enrollment Period

3 months

First QC Date

March 29, 2025

Last Update Submit

April 7, 2026

Conditions

Keywords

External cueShoulder StabilityStrength ExerciseAdolescent Swimmer

Outcome Measures

Primary Outcomes (7)

  • Change from baseline in isometric muscle torque production at 180 degrees shoulder abduction

    Handheld dynamometer assessment of force production times lever arm distance (Newton.meters) of prone shoulder elevation in 180 degrees of abduction completed at baseline, after 3 and 6 weeks of the training program.

    Baseline, 3 weeks, 6 weeks.

  • Change from baseline in isometric muscle torque production at 135 degrees shoulder abduction

    Handheld dynamometer assessment of force production times lever arm distance (Newton.meters) of prone shoulder elevation in 135 degrees of abduction completed at baseline, after 3 and 6 weeks of the training program.

    Baseline, 3 weeks, 6 weeks.

  • Change from baseline in isometric muscle torque production at 90 degrees shoulder abduction

    Handheld dynamometer assessment of force production times lever arm distance (Newton.meters) of prone shoulder elevation in 90 degrees of abduction completed at baseline, after 3 and 6 weeks of the training program.

    Baseline, 3 weeks, 6 weeks.

  • Change from baseline in modified Athletic Shoulder Test at 180 degrees shoulder abduction

    Maximum isometric force production with lying prone into a handheld dynamometer at a given lever arm distance results in muscle torque (Newton.meters) reading. This portion of the test is conducted at 180 degrees of abduction.

    Baseline, 3 weeks, 6 weeks.

  • Change from baseline in modified Athletic Shoulder Test at 135 degrees shoulder abduction

    Maximum isometric force production with lying prone into a handheld dynamometer at a given lever arm distance results in muscle torque (Newton.meters) reading. This portion of the test is conducted at 135 degrees of abduction.

    Baseline, 3 weeks, 6 weeks.

  • Change from baseline in modified Athletic Shoulder Test at 90 degrees shoulder abduction

    Maximum isometric force production with lying prone into a handheld dynamometer at a given lever arm distance results in muscle torque (Newton.meters) reading. This portion of the test is conducted at 90 degrees of abduction.

    Baseline, 3 weeks, 6 weeks.

  • Closed Kinetic Chain Upper Extremity Stability Test Power Score

    Two strips of tape are placed 36 inches apart. Participants assume a push up position (male) or pushup on knees (Female) and are instructed to reach across and touch the opposing hand alternating arms. Maximum number of touches in 15 seconds is recorded. Normalization is made by multiplying the raw touch score by 0.68 x Subject weight in Kg (representing the mass on the head arms and trunk) and dividing by the 15 seconds. Higher number indicates increased shoulder stability.

    Baseline, 6 weeks.

Secondary Outcomes (5)

  • Closed Kinetic Chain Upper Extremity Stability Test Raw Touch Score

    Baseline, 6 weeks.

  • Closed Kinetic Chain Upper Extremity Stability Test Touch Score

    Baseline, 6 weeks.

  • Maximal Prone Arm Elevation at 180 degrees abduction

    Baseline, 3 weeks, 6 weeks.

  • Maximal Prone Arm Elevation at 135 degrees abduction

    Baseline, 3 weeks, 6 weeks.

  • Maximal Prone Arm Elevation at 90 degrees abduction

    Baseline, 3 weeks, 6 weeks.

Study Arms (2)

Shoulder Stabilization Exercise

ACTIVE COMPARATOR

Protocol contains 8 exercises ("I", "Y", "T", "i", "w", alternating arm "I"/"i", "n", and supine serratus punch) completed for 8 repetitions each for 3 weeks, and in weeks 4-6 completed at 2 sets of 8 repetitions each. Standard group coaching assistance will be provided.

Other: Exercise

Shoulder Stabilization Exercise with External Cueing Device

EXPERIMENTAL

Protocol contains 8 exercises ("I", "Y", "T", "i", "w", alternating arm "I"/"i", "n", and supine serratus punch) completed for 8 repetitions each for 3 weeks, and in weeks 4-6 completed at 2 sets of 8 repetitions each. External cueing device provides movement pattern constraint and an external target zone for the individual for each exercise. Standard group coaching assistance will be provided.

Device: External Cueing DeviceOther: Exercise

Interventions

A portable product that provides movement pattern constraints to ensure improved exercise form, and provides a target zone for exercise effort

Shoulder Stabilization Exercise with External Cueing Device

Shoulder stabilization exercise protocol contains 8 exercises ("I", "Y", "T", "i", "w", alternating arm "I"/"i", "n", and supine serratus punch) completed for 8 repetitions each for 3 weeks, and in weeks 4-6 completed at 2 sets of 8 repetitions each.

Shoulder Stabilization ExerciseShoulder Stabilization Exercise with External Cueing Device

Eligibility Criteria

Age11 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Healthy Volunteer Adolescent Swimmers
  • Member of CMSA

You may not qualify if:

  • Swimmers under the age of 11 years of age.
  • Swimmers that are not registered as athletes through United States Swimming.
  • Swimmers that are not enrolled in Age Group III, Senior 1, Senior 2, or Senior 3
  • Swimmers not attending practice due to an injury (i.e., shoulder, back, etc.).
  • Swimmers currently not participating in a dryland program offered through CMSA.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fredericka G. Evans Cultural Centre

Mobile, Alabama, 36603, United States

Location

Related Publications (2)

  • de Oliveira VM, Pitangui AC, Nascimento VY, da Silva HA, Dos Passos MH, de Araujo RC. TEST-RETEST RELIABILITY OF THE CLOSED KINETIC CHAIN UPPER EXTREMITY STABILITY TEST (CKCUEST) IN ADOLESCENTS: RELIABILITY OF CKCUEST IN ADOLESCENTS. Int J Sports Phys Ther. 2017 Feb;12(1):125-132.

    PMID: 28217423BACKGROUND
  • Tooth C, Forthomme B, Croisier JL, Gofflot A, Bornheim S, Schwartz C. The Modified-Athletic Shoulder Test: Reliability and validity of a new on-field assessment tool. Phys Ther Sport. 2022 Nov;58:8-15. doi: 10.1016/j.ptsp.2022.08.003. Epub 2022 Aug 30.

    PMID: 36088802BACKGROUND

MeSH Terms

Interventions

Exercise

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: Exercise Program Alone Exercise Program with External Cueing Device
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor of Physical Therapy

Study Record Dates

First Submitted

March 29, 2025

First Posted

April 11, 2025

Study Start

April 20, 2025

Primary Completion

July 25, 2025

Study Completion

July 25, 2025

Last Updated

April 13, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Locations