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CompletedNCT06621628Updated Apr 17, 2026

Photobiomodulation in Children With Localized Scleroderma

An interventional study of Study Group A and Study GrouB in Localized Scleroderma, sponsored by New Ismailia National University. Completed at 2 sites in Egypt. Open to participants aged 8 Years to 11 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-04-17.

Sponsored by New Ismailia National University · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
21
Allocation
Randomized
Ages
8 Years to 11 Years
Sex
All
01

Study summary

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

Read the 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.

02

Conditions studied

  • Localized Scleroderma

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Keywords

  • Polarized light therapy
  • Resisted exercise
  • localized scleroderma
  • Modified Rodnon skin score
  • and Hand Grip Dynamometer
03

In context

Scleroderma, Localized

27 studies on the registry are indexed under Scleroderma, Localized; 4 are open to participants now.

This study's enrollment of 21 is below the median of 24 across 17 interventional studies indexed under Scleroderma, Localized.

Browse Scleroderma, Localized studies →

Lead sponsor

New Ismailia National University is the lead sponsor of 8 studies on the registry; 4 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
8 Years to 11 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
21 participants (actual)

Study arms

  • 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

  • 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

  • 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

Interventions

  • OtherStudy Group A

    resisted exercise

  • DeviceStudy GrouB

    Bioptron light therapy device, resisted exercises and stretching exercises

  • OtherStudy Group C

    , stretching and active range of motion hand exercises

06

What researchers measure

Primary outcomes

  1. skin thickness

    modified random skin score

    Time frame: 12 weeks

  2. hand grip strength and pinch gauge

    Hand dynamometer

    Time frame: 12 weeks

07

Study locations

2 sites
  • Khadra Mohamed Ali
    Ismailia, 8332601, Egypt
  • Mohamed Abdel Moenem Abo El Ros
    Ismailia, 8332601, Egypt
08

References and documents

Study documents

PDFs hosted by the registry, ClinicalTrials.gov.

Individual participant data

Plan to share: No — this proposal was assigned to evaluate skin thickness and pinch gauge concerning hand function using Bioptron light therapy in patients with crest syndrome

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 17, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06621628
Lead sponsor
New Ismailia National University
Responsible party
Mohamed Abdel Moeim Abo EL Ros (Lecturer of Physical Therapy for Pediatrics and its Surgeries, New Ismailia National University) — Principal investigator
First posted
Oct 1, 2024
Start date
Apr 10, 2025
Primary completion
Jul 1, 2025
Completion
Nov 5, 2025
Last update
Apr 17, 2026

Study contacts

Zakaria E Mowafy, Ph.D
study director · Cairo University

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Apr 2026. You cannot join it, but the record below documents what was studied.

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