Different Modalities Interventions Post Supracondylar Humeral Fracture in Pediatrics

Not Applicable

Recruiting

• Conditions: Supracondylar Humeral Fracture in Pediatric
• Interventions: Device: low level laser ,pulsed electromagnetic field .

• Registration Number: NCT06220812
• Lead Sponsor: Cairo University

Brief Summary

the aim of the study is comparing the effects of LLLT and PEMFT on range of motion of elbow and radioulnar joint ,pain ,muscles strength of upper limb and hand function in children with post-operative type II and III supracondylar humeral fracture.

Detailed Description

intervention study describe the effects of low level laser and pulsed electromagnetic field in children with supracondylar humeral fracture . All children will be randomly classified by envelope method into two study groups of equal number. study group A and study group B. Both groups will receive designed physical therapy program, 20 minutes, 3 times per week for six weeks in addition to study group A will receive LLLT, 5 minutes and study group B will receive the same physical therapy program, in addition to PEMF, 20 minutes.

Study Timeline

• Study Start: 2023-05-10
• Status Verified: 2024-01
• Study First Submitted: 2024-01-14
• Study First Submitted QC: 2024-01-14
• Last Update Submitted: 2024-01-14
• Study First Posted: 2024-01-24
• Last Update Posted: 2024-01-24
• Primary Completion: 2024-07-15
• Study Completion: 2024-10-15

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

1. Age ranges from 6 to 10 years of both genders.

2. All subjects have unilateral extension type II and III supracondylar humeral fracture requiring closed reduction and percutaneous pinning (CRPP).

3. The study will be start immediately after removal the splint.

4. Children clinically and medically stable.

5. Children able to follow verbal commands.

6. Children sample will represent those children who enrolled in schools and other not yet.

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Exclusion Criteria

The patients will be excluded if they have one of the following criteria;

1. Previous soft tissue injury at the same affected side of fracture.

2. Presence of associated fractures on the ipsilateral or contralateral upper limb.

3. Active infection near the fracture site.

4. Children with congenital or acquired skeletal deformities in the upper limbs.

5. Children with neurological deficits such as convulsions, involuntary movements, receiving muscle relaxants.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
study group A	low level laser ,pulsed electromagnetic field .	20 children will receive designed physical therapy program in addition to low level laser
study group B	low level laser ,pulsed electromagnetic field .	20 children will receive designed physical therapy program in addition to pulsed electromagnetic field .

Primary Outcome Measures

Name	Time	Method
Range of motion measurement	six weeks post intervention	The 2- in-1 Digital Angle Ruler goniometer will be used to assess elbow and radio-ulnar joint ROM (flexion-extension -supination and pronation) pre and post treatment in both groups
pain measurement	six weeks post intervention.	Numerical pain rating scale will be used to assess elbow pain intensity pre and post treatment in both groups.

Secondary Outcome Measures

Name	Time	Method
Hand function	six weeks post intervention	Jebsen-Taylor Hand Function Test (JHFT) will be used to assess hand function pre and post treatment in both groups.

Trial Locations

Locations (1)

General Beni-Seuif Hospital; 🇪🇬 Banī Suwayf, Egypt