Polarized Light Therapy in Patients With CREST Syndrome.

NCT ID: NCT06621628

Last Updated: 2024-10-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-04-10
• Study Completion Date: 2024-07-05

Brief Summary

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

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 patients with CREST syndrome, were participated in the study. Their ages were ranged from 16 to 45 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 20 patients who had CREST syndrome with 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 20 patients who have CREST syndrome with 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 20 patients who had CREST syndrome with 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), time of session was 15 minutes.

Conditions

CREST Syndrome

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Study group A

This group included 20 patients who had CREST syndrome with 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 Type: EXPERIMENTAL

stretching, strengthening exercises and active exercises

Intervention Type: OTHER

Bioptron light therapy device, resisted exercises and stretching exercises

study group B

This group included 20 patients who have CREST syndrome with 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

Group Type: EXPERIMENTAL

stretching, strengthening exercises and active exercises

Intervention Type: OTHER

Bioptron light therapy device, resisted exercises and stretching exercises

study group C

This group included 20 patients who had CREST syndrome with 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

Group Type: EXPERIMENTAL

stretching, strengthening exercises and active exercises

Intervention Type: OTHER

Bioptron light therapy device, resisted exercises and stretching exercises

Interventions

stretching, strengthening exercises and active exercises

Bioptron light therapy device, resisted exercises and stretching exercises

Intervention Type: OTHER

Other Intervention Names

resisted exercise, stretching and active exercises

Eligibility Criteria

Inclusion Criteria

• The patients' ages ranged from 16 to 21 years.
• Patients who had hand involvement of patients with CREST syndrome 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 polyneuropathy.
• Patients with thyroid problems

• Minimum Eligible Age: 16 Years
• Maximum Eligible Age: 21 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

New Ismailia National University

OTHER

Sponsor Role: lead

Responsible Party

Mohamed Abdel Moeim Abo EL Ros

Lecturer of Physical Therapy for Pediatrics and its Surgeries

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Zakaria E Mowafy, Ph.D

Role: STUDY_DIRECTOR

Cairo University

Locations

Khadra Mohamed Ali

Ismailia, , Egypt

Mohamed Abdel Moenem Abo El Ros

Ismailia, , Egypt

Countries

Egypt

Provided Documents

Document Type: Study Protocol, Statistical Analysis Plan, and Informed Consent Form

View Document

Other Identifiers

P.T.REC/012/004063

Identifier Type: -

Identifier Source: org_study_id