Photobiomodulation in Children With Localized Scleroderma (CREST)

April 16, 2026 updated by: Mohamed Abdel Moeim Abo EL Ros, New Ismailia National University

The Effectiveness of Photo-biomodulation and Hand Grip Strengthening on Children With Localized Scleroderma in the Egyptian Population : A Randomized Clinical Trial

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Measurement of the skin thickness via the modified Rodnon skin score (RSS) and Hand Grip Dynamometer (HGD) . Methods:- Sixty patients, who had hand involvement of children with localized scleroderma, were participated in the study. Their ages were ranged from 8 to 11 years. The participants were selected from the dermatology departments of Cairo university hospitals and Om El-Misrieen hospital, randomly distributed into three equal groups. Group A: (Study group): This group included 7 patients who had localized scleroderma in the dorsum of hands and who received the BLT 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. Group B: 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 and Group C:This group included 7 patients who had localized scleroderma in the dorsum of hands and who received combination of (BLT 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), the time of each session was 15 minutes.

Study Type

Interventional

Enrollment (Actual)

21

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Ismailia, Egypt, 8332601
        • Khadra Mohamed Ali
      • Ismailia, Egypt, 8332601
        • Mohamed Abdel Moenem Abo El Ros

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • 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).

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Study group A
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
resisted exercise
Experimental: study group B
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
Bioptron light therapy device, resisted exercises and stretching exercises
Experimental: study group C
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
, stretching and active range of motion hand exercises

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
skin thickness
Time Frame: 12 weeks
modified random skin score
12 weeks
hand grip strength and pinch gauge
Time Frame: 12 weeks
Hand dynamometer
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

New Ismailia National University

Investigators

  • Study Director: Zakaria E Mowafy, Ph.D, Cairo University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 10, 2025

Primary Completion (Actual)

July 1, 2025

Study Completion (Actual)

November 5, 2025

Study Registration Dates

First Submitted

September 26, 2024

First Submitted That Met QC Criteria

September 28, 2024

First Posted (Actual)

October 1, 2024

Study Record Updates

Last Update Posted (Actual)

April 17, 2026

Last Update Submitted That Met QC Criteria

April 16, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • REC/2111/MTI.PT/2511402

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

this proposal was assigned to evaluate skin thickness and pinch gauge concerning hand function using Bioptron light therapy in patients with crest syndrome

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

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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