- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04486703
Physical Therapy Rehabilitation Program Combined With Music on Pediatric With Lower Limb Burn
July 24, 2020 updated by: Marwa Eid, Cairo University
Effect of Physical Therapy Rehabilitation Program Combined With Music on Pediatric With Lower Limb Burn: a Twelve-week Randomized Controlled Study
The purpose of the current study was to evaluate the effect of physical therapy rehabilitation program combined with music therapy on pediatric with lower limb burn.
Methods.
A twelve-week randomized controlled study including thirty lower limb pediatric burned patients who randomly divided into two groups, Group(A) received physical therapy rehabilitation program combined with music therapy in addition to routine medical care while Group (B) received physical therapy rehabilitation program without music therapy.
Pain was assessed by visual analogue scale (VAS) and range of motion (ROM) was assessed by goniometer, and gait assessed by GAIT Rite.
Assessment was carried before and after treatment
Study Overview
Study Type
Interventional
Enrollment (Actual)
30
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
-
-
-
Cairo, Egypt, 2011
- Marwa Eid
-
-
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
10 years to 15 years (Child)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Lower limb 2nd degree burn since 6 weeks
- Burn affect skin around ankle and knee joint,
- Both sex, age ranged between 10 to 15 years old
- Patients have sufficient cognition and education enough to understand the requirements of this study
Exclusion Criteria:
- All patients with age more than 15 years or less than 10 years
- Patients with hearing problems
- Acute viral diseases, acute tuberculosis, mental disorders
- Those with pace makers, diabetics, cardiac, renal patients
- Patients with genetic disease
- 3rd degree burn and 1st degree bum
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: Exercise with music group
physical therapy program combined with music therapy
|
physical therapy program combined with music therapy 15 min, 3 times weekly for 12 weeks.
|
|
Experimental: Exercise group
physical therapy program without music
|
physical therapy program combined with music therapy 15 min, 3 times weekly for 12 weeks.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
pain in the lower limb
Time Frame: 12 weeks
|
Visual analogue scale for pain assessment ,zero indicates no pain ten indicates maximum pain
|
12 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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)
June 10, 2018
Primary Completion (Actual)
March 20, 2019
Study Completion (Actual)
June 15, 2019
Study Registration Dates
First Submitted
July 22, 2020
First Submitted That Met QC Criteria
July 23, 2020
First Posted (Actual)
July 24, 2020
Study Record Updates
Last Update Posted (Actual)
July 28, 2020
Last Update Submitted That Met QC Criteria
July 24, 2020
Last Verified
July 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 6m8
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
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.
Clinical Trials on Lower Limb Burn
-
Cairo UniversityNot yet recruitingLower Limb Burn | Lower Limb FunctionEgypt
-
Walaa Abd Elaziem Abd ElazizRecruiting
-
Hacettepe UniversityCompletedBurn Scar | Burns | Lower Limb Injury | Lower Limb WoundTurkey
-
Cairo UniversityNot yet recruitingBurns | Lower Limb Burn Injury
-
Cairo UniversityCompletedLower Limb BurnsEgypt
-
Cairo UniversityCompletedLower Limb Burn InjuryEgypt
-
Cairo UniversityCompletedMuscle Weakness Condition | Lower Limb BurnEgypt
-
University of Nevada, Las VegasUnited States Department of Defense; National Institutes of Health (NIH); University... and other collaboratorsRecruitingLower Limb Amputation Below Knee (Injury) | Lower Limb Amputation Above Knee (Injury) | Amputation | Lower Limb Amputation Knee | Lower Limb Amputation at Ankle (Injury) | Lower Limb Amputation at Hip (Injury)United States
-
Sint MaartenskliniekCompletedLower Limb Amputation Above Knee (Injury) | Lower Limb Amputation KneeNetherlands
-
Tezel Yıldırım ŞahanCompletedValidity and Reliability of The 3-Meter Backward Walk Test in Individuals With Lower Limb AmputationLower Limb Amputation Below Knee (Injury) | Lower Limb Amputation KneeTurkey
Clinical Trials on Exercise with music
-
University of MiamiCompleted
-
The Hong Kong Polytechnic UniversityNot yet recruitingChronic Pain | Pain Management | Elderly | Music-with-movement Exercise
-
WEIPENG DUANCompletedDrug Craving Levels Among Individuals With Substance Addiction | Depression Levels Among Individuals With Substance Addiction | Self-efficacy Among Individuals With Substance AddictionMalaysia
-
Tung Wah CollegeCompleted
-
Biruni UniversityCompleted
-
Eskisehir Osmangazi UniversityCompletedThe Effect of Progressive Relaxation Exercise With Music Therapy on Sleep Quality and Pain IntensityPostoperative Pain | Postoperative Sleep QualityTurkey
-
University of ValenciaCompleted
-
YALI ZHOUCompletedProblematic Smartphone UseMalaysia
-
University of ValenciaCompletedMental Health Disorder | LonelinessSpain
-
Universiti Sains MalaysiaRecruitingPsychological Stress | Aerobic Exercise | Medical StudentsChina