NCT07283302

Brief Summary

The goal of this observational study (single-patient case report) is to learn whether a structured pre-operative physical therapy rehabilitation program can improve shoulder function, reduce pain, and improve quality of life in an 11-year-old girl with humeral head and shaft deformity (post-inflammatory changes). The main questions it aims to answer are: Does shoulder range of motion and muscle strength improve after the program? Does pain and functional ability (including posture) improve after the program? Participants will: Attend 12 sessions over October-November 2025 (2 sessions/week) at the Faculty of Physical Therapy, Cairo University Receive a standardized session program that may include: TENS, low-level laser therapy, manual therapy (Spencer technique), phonophoresis PNF stretching and progressive exercises, plus scapular taping Complete evaluations at baseline, mid-program, and after the program, including goniometry (ROM), manual muscle testing, pain scale (VAS), postural assessment, and a functional ability checklist

Trial Health

87
On Track

Trial Health Score

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

Enrollment
1

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 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

Study Start

First participant enrolled

October 1, 2025

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2025

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

December 2, 2025

Completed
13 days until next milestone

First Posted

Study publicly available on registry

December 15, 2025

Completed
Last Updated

December 15, 2025

Status Verified

December 1, 2025

Enrollment Period

1 month

First QC Date

December 2, 2025

Last Update Submit

December 2, 2025

Conditions

Keywords

Pre-operative rehabilitationHumeral head deformityUpper limb deformityPre-operative rehabilitation (prehabilitation)

Outcome Measures

Primary Outcomes (3)

  • Range of Motion

    Shoulder range of motion will be assessed using a standard universal goniometer to quantify the motion of the affected upper limb.

    4 weeks

  • Manual Muscle Testing

    Upper-limb and shoulder muscle strength will be assessed using standardized Manual Muscle Testing procedures. Key muscle groups around the shoulder and scapula (e.g., shoulder flexors, abductors, internal/external rotators, and scapular stabilizers)

    4 weeks

  • Functional Ability

    Functional status of the affected upper limb will be assessed using the Quick Disabilities of the Arm, Shoulder and Hand (QuickDASH) questionnaire. The patient (with caregiver assistance as needed) will rate the difficulty of performing common daily activities and the impact of symptoms such as pain on function. Responses are summed and converted to a 0-100 score, where higher scores indicate greater disability.

    4 weeks

Secondary Outcomes (1)

  • Pain intensity

    4 weeks

Study Arms (1)

interventional

EXPERIMENTAL

This single-arm case report includes a structured pre-operative physical therapy rehabilitation program for a pediatric patient with humeral head and shaft deformity. The intervention consists of supervised sessions incorporating pain-modulation modalities (as clinically indicated), manual therapy to improve shoulder mobility, therapeutic exercises for flexibility, strengthening, and neuromuscular control, and scapular stabilization/positioning strategies (including taping as needed). Treatment is progressed based on tolerance and clinical response, with the goal of improving pre-operative shoulder pain, range of motion, strength, posture, and functional use of the upper limb.

Device: Transcutaneous Electrical Nerve StimulationDevice: Low-Level Laser TherapyOther: Manual TherapyOther: PhonophoresisOther: PNF stretchingOther: kinesio taping

Interventions

a method of pain relief that uses a device to send low-voltage electrical impulses through electrodes placed on the skin

interventional

a non-invasive medical treatment that uses low-level lasers or light-emitting diodes (LEDs) to stimulate cell function and accelerate the body's natural healing process

interventional

a hands-on treatment approach

interventional

a medical procedure that uses therapeutic ultrasound to deliver topical medications through the skin and into deeper tissues

Also known as: Ultrasound
interventional

is an advanced technique that combines muscle contraction and relaxation to increase flexibility and range of motion

interventional

Kinesio tape will be applied to the shoulder and scapular region to support improved alignment and scapular control during movement.

interventional

Eligibility Criteria

Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • \- Not applicable (case report; single patient case).

You may not qualify if:

  • \- Not applicable (case report; single patient case).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Out patinets clinics, Faculty of Physical Therapy Cairo University

Giza, 11432, Egypt

Location

MeSH Terms

Interventions

Transcutaneous Electric Nerve StimulationLow-Level Light TherapyMusculoskeletal ManipulationsPhonophoresisHigh-Energy Shock WavesMuscle Stretching Exercises

Intervention Hierarchy (Ancestors)

Electric Stimulation TherapyTherapeuticsPhysical Therapy ModalitiesRehabilitationAnalgesiaAnesthesia and AnalgesiaLaser TherapyPhototherapyComplementary TherapiesDrug Administration RoutesDrug TherapyUltrasonic WavesSoundRadiation, NonionizingRadiationPhysical PhenomenaExercise TherapyAftercareContinuity of Patient CarePatient CareExerciseMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Researcher

Study Record Dates

First Submitted

December 2, 2025

First Posted

December 15, 2025

Study Start

October 1, 2025

Primary Completion

November 1, 2025

Study Completion

November 1, 2025

Last Updated

December 15, 2025

Record last verified: 2025-12

Data Sharing

IPD Sharing
Will not share

Locations