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Completed

NCT Number: NCT06621628

Photobiomodulation in Children With Localized Scleroderma

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

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Key information

Age range

8 year–11 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Khadra Mohamed Ali, Ismailia, Egypt

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Study Group A

Other

resisted exercise

Study GrouB

Device

Bioptron light therapy device, resisted exercises and stretching exercises

Study Group C

Other

, stretching and active range of motion hand exercises

Primary outcomes

  1. skin thickness

    Time frame: 12 weeks

    modified random skin score

  2. hand grip strength and pinch gauge

    Time frame: 12 weeks

    Hand dynamometer

Sponsors and collaborators

Lead sponsor

New Ismailia National University

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Oct 1, 2024
Registry last updated
Apr 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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