Different Modalities Interventions Post Supracondylar Humeral Fracture in Pediatrics

NCT ID: NCT06220812

Last Updated: 2024-01-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-05-10

Study Completion Date

2024-10-15

Brief Summary

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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

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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.

Conditions

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Supracondylar Humeral Fracture in Pediatric

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

low level laser and pulsed electromagnetic field will be applied separated to different study groups of children with supracondylar humeral fracture.
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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study group A

20 children will receive designed physical therapy program in addition to low level laser

Group Type EXPERIMENTAL

low level laser ,pulsed electromagnetic field .

Intervention Type DEVICE

LLL ,ASA via Alessandro Volta, 9 .36057 Arcugnano- Italy. With 905-nm wavelength, and maximum power output of 500 mW, laser spot of approximately 1 cm2 .

PEMF, ASA, Easy teraza serie (ETS), Italy 2011, its code F9020087 and 230 its voltage.

study group B

20 children will receive designed physical therapy program in addition to pulsed electromagnetic field .

Group Type EXPERIMENTAL

low level laser ,pulsed electromagnetic field .

Intervention Type DEVICE

LLL ,ASA via Alessandro Volta, 9 .36057 Arcugnano- Italy. With 905-nm wavelength, and maximum power output of 500 mW, laser spot of approximately 1 cm2 .

PEMF, ASA, Easy teraza serie (ETS), Italy 2011, its code F9020087 and 230 its voltage.

Interventions

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low level laser ,pulsed electromagnetic field .

LLL ,ASA via Alessandro Volta, 9 .36057 Arcugnano- Italy. With 905-nm wavelength, and maximum power output of 500 mW, laser spot of approximately 1 cm2 .

PEMF, ASA, Easy teraza serie (ETS), Italy 2011, its code F9020087 and 230 its voltage.

Intervention Type DEVICE

Eligibility Criteria

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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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Minimum Eligible Age

6 Years

Maximum Eligible Age

10 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Cairo University

OTHER

Sponsor Role lead

Responsible Party

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Amira Ezzat Abd El Mageid

M.Sc. in Physical Therapy, Cairo University

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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General hospital Beni-Seuif Beni-seuif

Role: STUDY_CHAIR

[email protected]

Locations

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General Beni-Seuif Hospital

Banī Suwayf, , Egypt

Site Status RECRUITING

Countries

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Egypt

Central Contacts

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Amira Ezzat, master degree

Role: CONTACT

01111730705

Hoda Eltalawy, professer

Role: CONTACT

01006605506

Facility Contacts

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Manal Bakery

Role: primary

01002326350

Fatma Ahmed

Role: backup

01212185579

References

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Mulpuri K, Hosalkar H, Howard A. AAOS clinical practice guideline: the treatment of pediatric supracondylar humerus fractures. J Am Acad Orthop Surg. 2012 May;20(5):328-30. doi: 10.5435/JAAOS-20-05-328. No abstract available.

Reference Type BACKGROUND
PMID: 22553105 (View on PubMed)

Vaquero-Picado A, Gonzalez-Moran G, Moraleda L. Management of supracondylar fractures of the humerus in children. EFORT Open Rev. 2018 Oct 1;3(10):526-540. doi: 10.1302/2058-5241.3.170049. eCollection 2018 Oct.

Reference Type BACKGROUND
PMID: 30662761 (View on PubMed)

Related Links

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Other Identifiers

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SCHF-LLL-PEMF

Identifier Type: -

Identifier Source: org_study_id

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