Photobiomodulation in Children With Localized Scleroderma

NCT06621628 | Completed

• 1 other identifier: REC/2111/MTI.PT/2511402
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 2

Brief Summary

to evaluate the efficacy of the Polarized light therapy and Hand Grip Strengthening exercises in patients with CREST syndrome

Conditions

Localized Scleroderma

Keywords

Polarized light therapy; Resisted exercise; localized scleroderma; Modified Rodnon skin score; and Hand Grip Dynamometer

Outcome Measures

Primary Outcomes (2)

• skin thickness

  modified random skin score

  12 weeks

• hand grip strength and pinch gauge

  Hand dynamometer

  12 weeks

Study Arms (3)

Study group A

EXPERIMENTAL

This group included 7 patients who had localized scleroderma in the dorsum of hands and who received the photobiomodulaion with traditional physical therapy program (stretching, strengthening and active exercise) patients received 3 sessions per week for 12 weeks (3 months),time of session is 15 minutes.

Other: Study Group A

study group B

EXPERIMENTAL

This group included 7 patients who have localized scleroderma in the dorsum of hands and who received resisted exercise with traditional physical therapy program (stretching, strengthening and active exercise) patients received 3 sessions per week for 12 weeks (3 months), time of session is 15 minutes

Device: Study GrouB

study group C

EXPERIMENTAL

This group included 7 patients who had localized scleroderma in the dorsum of hands and who received combination of (bipotron light therapy and resisted exercise) with traditional physical therapy program (stretching, strengthening and active exercise) exercise program (stretching, strengthening and active exercise).patients received 3 sessions per week for 12weeks (3 months), time of session is 15 minutes

Other: Study Group C

Interventions

Study Group A OTHER

resisted exercise

Study group A

Study GrouB DEVICE

Bioptron light therapy device, resisted exercises and stretching exercises

study group B

Study Group C OTHER

, stretching and active range of motion hand exercises

study group C

Eligibility Criteria

• Age: 8 Years - 11 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• The patients' ages ranged from 8 to 11 years.
• Patients who had hand involvement of patients with localized scleroderma, particularly dorsum of the hand.
• All patients were conscious.
• All patients were randomly chosen (male and female).

You may not qualify if:

• Patients who are diabetic or hypertensive.
• Patients those familiar with the BLT and resisted exercise via the hand grip strengthener.
• Patients with hemorrhage specially hemorrhage of digestive system and those with bleeding per rectum.
• Patients with severe fungal diseases and acute viral diseases.
• Patients with active tuberculosis and tumors as well as those with peacemakers.
• Patients with thyroid problems

Sponsors & Collaborators

• New Ismailia National University: lead

Study Sites (2)

Khadra Mohamed Ali

Ismailia, 8332601, Egypt

Location

Mohamed Abdel Moenem Abo El Ros

Ismailia, 8332601, Egypt

Location

MeSH Terms

Conditions

Scleroderma, Localized

Condition Hierarchy (Ancestors)

Connective Tissue Diseases; Skin and Connective Tissue Diseases; Skin Diseases

Study Officials

• Zakaria E Mowafy, Ph.D

  Cairo University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: masking was done by sealed envelopes
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer of Physical Therapy for Pediatrics and its Surgeries

Model Details: to evaluate the efficacy of the Polarized light therapy and Hand Grip Strengthening exercises in patients with CREST syndrome.

Study Record Dates

• First Submitted: September 26, 2024
• First Posted: October 1, 2024
• Study Start: April 10, 2025
• Primary Completion: July 1, 2025
• Study Completion: November 5, 2025
• Last Updated: April 17, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

EG (2)