NCT04486703

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2018

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 10, 2018

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 20, 2019

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 15, 2019

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

July 22, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 24, 2020

Completed
Last Updated

July 28, 2020

Status Verified

July 1, 2020

Enrollment Period

9 months

First QC Date

July 22, 2020

Last Update Submit

July 24, 2020

Conditions

Outcome Measures

Primary Outcomes (1)

  • pain in the lower limb

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

    12 weeks

Study Arms (2)

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

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

Exercise groupExercise with music group

Eligibility Criteria

Age10 Years - 15 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • rd degree burn and 1st degree bum

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Marwa Eid

Cairo, 2011, Egypt

Location

MeSH Terms

Interventions

Exercise

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
assistant professor of physical therapy for surgery

Study Record Dates

First Submitted

July 22, 2020

First Posted

July 24, 2020

Study Start

June 10, 2018

Primary Completion

March 20, 2019

Study Completion

June 15, 2019

Last Updated

July 28, 2020

Record last verified: 2020-07

Locations