NCT07067216

Brief Summary

The purpose of this study is to investigate the combined effect of biofeedback and scapular stabilization exercises on swimmer's shoulder in pediatric elite swimmers.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet 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

First Submitted

Initial submission to the registry

July 5, 2025

Completed
7 days until next milestone

Study Start

First participant enrolled

July 12, 2025

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 16, 2025

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 12, 2025

Completed
14 days until next milestone

Study Completion

Last participant's last visit for all outcomes

October 26, 2025

Completed
Last Updated

July 16, 2025

Status Verified

July 1, 2025

Enrollment Period

3 months

First QC Date

July 5, 2025

Last Update Submit

July 5, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • The Shoulder Pain and Disability Index (SPADI)

    The SPADI uses a 10 cm visual analogue scale for each question, with anchors from "no pain/difficulty" to "worst pain imaginable/so difficult it required help." Pain (5 items) and disability (8 items) scores are calculated separately and converted to percentages: pain (/50), disability (/80), and total SPADI (/130). If questions are skipped, scores are divided by the total possible. The final score (0-100) reflects shoulder impairment, with higher scores indicating worse function. A change of at least 13 points is needed to be considered meaningful beyond measurement error.

    6 weeks

Secondary Outcomes (3)

  • Digital Inclinometer

    6 weeks

  • Digital goniometer

    6 weeks

  • Kibler's Test (Lateral Scapular Slide Test)

    6 weeks

Study Arms (2)

Designed scapular stabilization using pressure biofeedback

EXPERIMENTAL

This group will consist of 20 participants, who will receive a designed scapular stabilization exercise program using pressure biofeedback. The program will be applied for one hour, two times per week, for 6 successive weeks.

Other: Designed scapular stabilization using pressure biofeedback

Designed physical therapy program

ACTIVE COMPARATOR

This group will consist of 20 participants, who will receive a designed physical therapy program. The program will be applied for one hour, two times per week, for 6 successive weeks.

Other: Designed physical therapy program

Interventions

Patients will attend 1-hour physical therapy sessions twice weekly for 6 weeks. The program will include posterior capsule mobilization, scapular stabilization using pressure biofeedback (targeting lower trapezius, latissimus dorsi, pectoralis major, deep cervical flexors, and scapular retractors), and strengthening exercises using therabands: external rotation, shoulder diagonals, rows, and extensions. Additional training will involve physioball scapular exercises (up/down \& side/side), prone scapular strengthening (e.g., TYI, superman), and scapular-clock drills to improve mobility, proprioception, and stability.

Designed scapular stabilization using pressure biofeedback

Patients will receive cryotherapy and perform stretching exercises for the pectoralis minor and posterior capsule. Strengthening exercises using theraband will target the rotator cuff (especially external rotators) and scapular depressors/retractors. Scapular stabilization will be trained through prone exercises on a ball (T, Y, W) and on a plinth, including rowing, horizontal abduction, extension, superman, and TYI exercises. Additionally, patients will perform the scapular-clock exercise to enhance mobility, control, and proprioception.

Designed physical therapy program

Eligibility Criteria

Age9 Years - 13 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Both sexes form 9-13 years old and active in competitive swimming clubs
  • Swimming styles will be selected are butterfly and backstroke styles and the swimmers undergone an average minimum of 4 hours of swimming per week.
  • All pediatric swimmers have shoulder pain.
  • All of them are not allowed to practice swimming during study.

You may not qualify if:

  • Pediatric swimmers who practice any sport related to overhead activities.
  • Swimmers who had dermatological problems.
  • Past history of upper limb fractures or surgeries.
  • Swimmers who had any neurological condition (like winging scapula due to nerve damage).
  • Swimmers who had dorsal scoliosis (s or c shaped).
  • Swimmers who integrate in swimming competitions at the same time of study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

EL Hawar and Geziret Elward sporting clubs

Al Mansurah, Egypt

Location

Study Officials

  • Nanees Essam Mohamed Salem, PhD

    Professor, Cairo university

    STUDY CHAIR
  • Shimaa Mohamed Reffat, PhD

    Assistant Professor, Cairo university

    STUDY DIRECTOR

Central Study Contacts

Osama Ali Hamed Mohamed, M.Sc

CONTACT

Shimaa Mohamed Reffat, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

July 5, 2025

First Posted

July 16, 2025

Study Start

July 12, 2025

Primary Completion

October 12, 2025

Study Completion

October 26, 2025

Last Updated

July 16, 2025

Record last verified: 2025-07

Locations