Physical Therapy Rehabilitation Program Combined With Mus... | NCT04486703

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

NCT04486703

Sponsor

Cairo University

Status

Completed

Last Update Posted

Jul 28, 2020Actual

Enrollment

30Actual

Phase

Not Applicable

Conditions

Lower Limb Burn

Interventions

Exercise with music

Countries

Egypt

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2020

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 10, 2018Actual

Primary Completion Date

Mar 20, 2019Actual

Completion Date

Jun 15, 2019Actual

First Submitted Date

Jul 22, 2020

First Submission Date that Met QC Criteria

Jul 23, 2020

First Posted Date

Jul 24, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 24, 2020

Last Update Posted Date

Jul 28, 2020Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

30Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Exercise with music group	Experimental	physical therapy program combined with music therapy	Other: Exercise with music
Exercise group	Experimental	physical therapy program without music	Other: Exercise with music

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Exercise with music	Other	physical therapy program combined with music therapy 15 min, 3 times weekly for 12 weeks.	Exercise group Exercise with music group

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
pain in the lower limb	Visual analogue scale for pain assessment ,zero indicates no pain ten indicates maximum pain	12 weeks

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

10 Years

Maximum Age

15 Years

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

Facility	Status	City	State	ZIP	Country	Contacts
Marwa Eid		Cairo		2011	Egypt

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D015444	Exercise

Ancestor Terms

ID	Term
D009043	Motor Activity
D009068	Movement
D009142	Musculoskeletal Physiological Phenomena
D055687	Musculoskeletal and Neural Physiological Phenomena

Browse Leaves

Not provided

Browse Branches

Not provided