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Physical Therapy Rehabilitation Program Combined With Music on Pediatric With Lower Limb Burn

Primary Purpose

Lower Limb Burn

Status

Completed

Phase

Not Applicable

Locations

Egypt

Study Type

Interventional

Intervention

Exercise with music

About this trial

This is an interventional treatment trial for Lower Limb Burn

Eligibility Criteria

10 Years - 15 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Marwa Eid

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Exercise with music group

Exercise group

Arm Description

physical therapy program combined with music therapy

physical therapy program without music

Outcomes

Primary Outcome Measures

pain in the lower limb

Visual analogue scale for pain assessment ,zero indicates no pain ten indicates maximum pain

Secondary Outcome Measures

Full Information

NCT ID

NCT04486703

First Posted

July 22, 2020

Last Updated

July 24, 2020

Sponsor

Cairo University

1. Study Identification

Unique Protocol Identification Number

NCT04486703

Brief Title

Physical Therapy Rehabilitation Program Combined With Music on Pediatric With Lower Limb Burn

Official Title

Effect of Physical Therapy Rehabilitation Program Combined With Music on Pediatric With Lower Limb Burn: a Twelve-week Randomized Controlled Study

Study Type

Interventional

2. Study Status

Record Verification Date

July 2020

Overall Recruitment Status

Completed

Study Start Date

June 10, 2018 (Actual)

Primary Completion Date

March 20, 2019 (Actual)

Study Completion Date

June 15, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Cairo University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

Brief Summary

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Lower Limb Burn

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Participant

Allocation

Randomized

Enrollment

30 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Exercise with music group

Arm Type

Experimental

Arm Description

physical therapy program combined with music therapy

Arm Title

Exercise group

Arm Type

Experimental

Arm Description

physical therapy program without music

Intervention Type

Other

Intervention Name(s)

Exercise with music

Intervention Description

physical therapy program combined with music therapy 15 min, 3 times weekly for 12 weeks.

Primary Outcome Measure Information:

Title

pain in the lower limb

Description

Visual analogue scale for pain assessment ,zero indicates no pain ten indicates maximum pain

Time Frame

12 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

10 Years

Maximum Age & Unit of Time

15 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Facility Information:

Facility Name

Marwa Eid

City

Cairo

ZIP/Postal Code

2011

Country

Egypt

12. IPD Sharing Statement

Plan to Share IPD

Undecided

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Physical Therapy Rehabilitation Program Combined With Music on Pediatric With Lower Limb Burn

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