- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07283302
Pre-Surgery Rehab for a Child With Humeral Head and Shaft Deformity: A Case Report
Pre-operative Rehabilitation Protocol for a Pediatric Patient With Humeral Head and Shaft Deformity: A Case Report
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
Study Overview
Status
Conditions
Detailed Description
This study is a single-patient case report describing the design, delivery, and observed response to a pre-operative rehabilitation program for a pediatric patient with deformity involving the humeral head and shaft. The report will document the patient's baseline presentation, the clinical reasoning used to select pre-operative rehabilitation goals, and the step-by-step rehabilitation approach used to optimize the shoulder and upper-limb condition before planned surgical management.
The rehabilitation program is intended to maximize safe functional capacity pre-operatively by addressing modifiable impairments commonly associated with this condition, such as pain, limited range of motion, weakness, altered scapulohumeral mechanics, and compensatory movement patterns. The case report will describe treatment components (e.g., education, therapeutic exercise, flexibility and strengthening strategies, neuromuscular re-education, and other noninvasive physical therapy modalities as clinically indicated), how the program is progressed over time, and any precautions used to ensure age-appropriate and condition-appropriate care.
To evaluate response to the program, the study will collect structured pre- and post-program measurements relevant to shoulder/upper-limb status, such as:
- Pain and symptom severity
- Shoulder range of motion
- Muscle strength and/or functional performance
- Activity limitations and functional use of the affected arm
- Observed posture and movement quality (as clinically applicable) The report will also capture treatment adherence, any adverse events, and notable barriers/facilitators to participation (e.g., tolerance, fatigue, caregiver involvement). Findings will be presented descriptively to help clinicians and families understand what a pre-operative rehabilitation plan may include for a child with humeral deformity, and what types of short-term changes may be observed during the pre-surgical period.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Giza, Egypt, 11432
- Out patinets clinics, Faculty of Physical Therapy Cairo University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Not applicable (case report; single patient case).
Exclusion Criteria:
- Not applicable (case report; single patient case).
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: interventional
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.
|
a method of pain relief that uses a device to send low-voltage electrical impulses through electrodes placed on the skin
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
a hands-on treatment approach
a medical procedure that uses therapeutic ultrasound to deliver topical medications through the skin and into deeper tissues
Other Names:
is an advanced technique that combines muscle contraction and relaxation to increase flexibility and range of motion
Kinesio tape will be applied to the shoulder and scapular region to support improved alignment and scapular control during movement.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Range of Motion
Time Frame: 4 weeks
|
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
Time Frame: 4 weeks
|
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
Time Frame: 4 weeks
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Pain intensity
Time Frame: 4 weeks
|
Pain intensity will be measured using a Visual Analog Scale (VAS).
The patient will be asked to rate her pain by marking on a 10-cm line anchored by "no pain" (0) and "worst pain imaginable" (10).
|
4 weeks
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Motor Activity
- Movement
- Musculoskeletal Physiological Phenomena
- Musculoskeletal and Neural Physiological Phenomena
- Therapeutics
- Drug Administration Routes
- Drug Therapy
- Complementary Therapies
- Physical Therapy Modalities
- Physical Phenomena
- Patient Care
- Exercise Therapy
- Rehabilitation
- Aftercare
- Continuity of Patient Care
- Anesthesia and Analgesia
- Radiation
- Exercise
- Radiation, Nonionizing
- Electric Stimulation Therapy
- Laser Therapy
- Phototherapy
- Analgesia
- Ultrasonic Waves
- Sound
- Low-Level Light Therapy
- Musculoskeletal Manipulations
- Transcutaneous Electric Nerve Stimulation
- High-Energy Shock Waves
- Muscle Stretching Exercises
- Phonophoresis
Other Study ID Numbers
- P.T.REC/012/006101
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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