Ignite Creation Date:
2025-12-25 @ 3:47 AM
Ignite Modification Date:
2025-12-26 @ 2:34 AM
Study NCT ID:
NCT07283302
Status:
COMPLETED
Last Update Posted:
2025-12-15
First Post:
2025-12-02
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Pre-Surgery Rehab for a Child With Humeral Head and Shaft Deformity: A Case Report
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D004561', 'term': 'Transcutaneous Electric Nerve Stimulation'}, {'id': 'D028022', 'term': 'Low-Level Light Therapy'}, {'id': 'D026201', 'term': 'Musculoskeletal Manipulations'}, {'id': 'D015612', 'term': 'Phonophoresis'}, {'id': 'D019220', 'term': 'High-Energy Shock Waves'}, {'id': 'D052580', 'term': 'Muscle Stretching Exercises'}], 'ancestors': [{'id': 'D004599', 'term': 'Electric Stimulation Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D026741', 'term': 'Physical Therapy Modalities'}, {'id': 'D012046', 'term': 'Rehabilitation'}, {'id': 'D000698', 'term': 'Analgesia'}, {'id': 'D000760', 'term': 'Anesthesia and Analgesia'}, {'id': 'D053685', 'term': 'Laser Therapy'}, {'id': 'D010789', 'term': 'Phototherapy'}, {'id': 'D000529', 'term': 'Complementary Therapies'}, {'id': 'D004333', 'term': 'Drug Administration Routes'}, {'id': 'D004358', 'term': 'Drug Therapy'}, {'id': 'D000069453', 'term': 'Ultrasonic Waves'}, {'id': 'D013016', 'term': 'Sound'}, {'id': 'D011840', 'term': 'Radiation, Nonionizing'}, {'id': 'D011827', 'term': 'Radiation'}, {'id': 'D055585', 'term': 'Physical Phenomena'}, {'id': 'D005081', 'term': 'Exercise Therapy'}, {'id': 'D000359', 'term': 'Aftercare'}, {'id': 'D003266', 'term': 'Continuity of Patient Care'}, {'id': 'D005791', 'term': 'Patient Care'}, {'id': 'D015444', 'term': 'Exercise'}, {'id': 'D009043', 'term': 'Motor Activity'}, {'id': 'D009068', 'term': 'Movement'}, {'id': 'D009142', 'term': 'Musculoskeletal Physiological Phenomena'}, {'id': 'D055687', 'term': 'Musculoskeletal and Neural Physiological Phenomena'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2025-10-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2025-11-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-12-02', 'studyFirstSubmitDate': '2025-12-02', 'studyFirstSubmitQcDate': '2025-12-02', 'lastUpdatePostDateStruct': {'date': '2025-12-15', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-12-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2025-11-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Range of Motion', 'timeFrame': '4 weeks', 'description': 'Shoulder range of motion will be assessed using a standard universal goniometer to quantify the motion of the affected upper limb.'}, {'measure': 'Manual Muscle Testing', 'timeFrame': '4 weeks', 'description': '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)'}, {'measure': 'Functional Ability', 'timeFrame': '4 weeks', 'description': '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.'}], 'secondaryOutcomes': [{'measure': 'Pain intensity', 'timeFrame': '4 weeks', 'description': '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).'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Pre-operative rehabilitation', 'Humeral head deformity', 'Upper limb deformity', 'Pre-operative rehabilitation (prehabilitation)'], 'conditions': ['Osteomyelitis Chronic', 'Bone Defects']}, 'descriptionModule': {'briefSummary': '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).\n\nThe main questions it aims to answer are:\n\nDoes shoulder range of motion and muscle strength improve after the program? Does pain and functional ability (including posture) improve after the program?\n\nParticipants will:\n\nAttend 12 sessions over October-November 2025 (2 sessions/week) at the Faculty of Physical Therapy, Cairo University\n\nReceive a standardized session program that may include:\n\nTENS, 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', 'detailedDescription': "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.\n\nThe 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.\n\nTo evaluate response to the program, the study will collect structured pre- and post-program measurements relevant to shoulder/upper-limb status, such as:\n\n* Pain and symptom severity\n* Shoulder range of motion\n* Muscle strength and/or functional performance\n* Activity limitations and functional use of the affected arm\n* 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."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n\\- Not applicable (case report; single patient case).\n\nExclusion Criteria:\n\n\\- Not applicable (case report; single patient case).'}, 'identificationModule': {'nctId': 'NCT07283302', 'briefTitle': 'Pre-Surgery Rehab for a Child With Humeral Head and Shaft Deformity: A Case Report', 'organization': {'class': 'OTHER', 'fullName': 'Cairo University'}, 'officialTitle': 'Pre-operative Rehabilitation Protocol for a Pediatric Patient With Humeral Head and Shaft Deformity: A Case Report', 'orgStudyIdInfo': {'id': 'P.T.REC/012/006101'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'interventional', 'description': '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.', 'interventionNames': ['Device: Transcutaneous Electrical Nerve Stimulation', 'Device: Low-Level Laser Therapy', 'Other: Manual Therapy', 'Other: Phonophoresis', 'Other: PNF stretching', 'Other: kinesio taping']}], 'interventions': [{'name': 'Transcutaneous Electrical Nerve Stimulation', 'type': 'DEVICE', 'description': 'a method of pain relief that uses a device to send low-voltage electrical impulses through electrodes placed on the skin', 'armGroupLabels': ['interventional']}, {'name': 'Low-Level Laser Therapy', 'type': 'DEVICE', 'description': "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", 'armGroupLabels': ['interventional']}, {'name': 'Manual Therapy', 'type': 'OTHER', 'description': 'a hands-on treatment approach', 'armGroupLabels': ['interventional']}, {'name': 'Phonophoresis', 'type': 'OTHER', 'otherNames': ['Ultrasound'], 'description': 'a medical procedure that uses therapeutic ultrasound to deliver topical medications through the skin and into deeper tissues', 'armGroupLabels': ['interventional']}, {'name': 'PNF stretching', 'type': 'OTHER', 'description': 'is an advanced technique that combines muscle contraction and relaxation to increase flexibility and range of motion', 'armGroupLabels': ['interventional']}, {'name': 'kinesio taping', 'type': 'OTHER', 'description': 'Kinesio tape will be applied to the shoulder and scapular region to support improved alignment and scapular control during movement.', 'armGroupLabels': ['interventional']}]}, 'contactsLocationsModule': {'locations': [{'zip': '11432', 'city': 'Giza', 'country': 'Egypt', 'facility': 'Out patinets clinics, Faculty of Physical Therapy Cairo University', 'geoPoint': {'lat': 30.00944, 'lon': 31.20861}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cairo University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Researcher', 'investigatorFullName': 'Sameh Eldaly', 'investigatorAffiliation': 'Cairo University'}}}}