NCT06036082

Brief Summary

Burn wounds are one of the most complexes and dramatic of all injuries, it produces a direct local tissue destruction and damage. In addition, burn wounds may continue to destroy tissue and muscles, exercise therapy stimulates the early expression of angiogenesis-related growth factors so it results in new vessel in-growth that improves blood supply, increases cell proliferation, accelerates tissue regeneration and healing and regain muscle strength

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

First Submitted

Initial submission to the registry

September 2, 2023

Completed
11 days until next milestone

First Posted

Study publicly available on registry

September 13, 2023

Completed
1 month until next milestone

Study Start

First participant enrolled

October 15, 2023

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 15, 2024

Completed
5 days until next milestone

Study Completion

Last participant's last visit for all outcomes

January 20, 2024

Completed
Last Updated

October 13, 2023

Status Verified

October 1, 2023

Enrollment Period

3 months

First QC Date

September 2, 2023

Last Update Submit

October 11, 2023

Conditions

Keywords

Burn; Children; Isokinetic Training; Treadmill Training

Outcome Measures

Primary Outcomes (1)

  • Balance Master System

    It is the most significant test to measure balance and has valid values of functional balance performance

    before intervention and after 12 weeks of intervention

Secondary Outcomes (1)

  • Hand-held dynamometer

    before intervention and after 12 weeks of intervention

Study Arms (3)

Conventional physical therapy group

EXPERIMENTAL

It consisted of 20 children received conventional physical therapy program

Other: Conventional physical therapy

isokinetic training group

EXPERIMENTAL

It consisted of 20 children received conventional physical therapy program and isokinetic training

Other: Conventional physical therapy

Treadmill training group

EXPERIMENTAL

It consisted of 20 children received conventional physical therapy program and treadmill training

Other: Conventional physical therapy

Interventions

* Standing with feet together . * Step standing . * High step standing and trying to keep balanced. * Single leg stance "unilateral standing" with assistance. * Standing on a declined surface by using wedge. * Standing with manual locking of the knees. * Changing position. * Gait training. * Static and dynamic muscle contraction.

Also known as: physical therapy program
Conventional physical therapy groupTreadmill training groupisokinetic training group

Eligibility Criteria

Age8 Years - 16 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Children aged between 8 to 16 year
  • Complaining from 2nd degree lower limb burns (≥30 % of their TBSA).
  • Capable of standing and walking independently.
  • Clinically and medically stable.
  • Sufficient cognition demonstrating understanding the requirements of the study.
  • No history of lower extremity surgery.

You may not qualify if:

  • Visual and/or auditory defects.
  • Significant shortening and/or deformity of lower extremities.
  • Other neurological problems that affect balance or mentality (e.g. epilepsy).
  • Advanced radiographic changes include (bone destruction, bony ankylosis, knee joint sublaxation and epiphysial fracture).
  • Congenital or acquired skeletal deformities in the lower limbs.
  • Cardiopulmonary dysfunction.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ragaee Saeed Mahmoud

Faisal, Giza Governorate, 00202, Egypt

RECRUITING

MeSH Terms

Conditions

Burns

Condition Hierarchy (Ancestors)

Wounds and Injuries

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: randomized control study
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer

Study Record Dates

First Submitted

September 2, 2023

First Posted

September 13, 2023

Study Start

October 15, 2023

Primary Completion

January 15, 2024

Study Completion

January 20, 2024

Last Updated

October 13, 2023

Record last verified: 2023-10

Data Sharing

IPD Sharing
Will share

assessed before and after treatment

Shared Documents
STUDY PROTOCOL
Time Frame
12 weeks
Access Criteria
accepted

Locations