Isokinetic Training Versus Treadmill Training on Muscle Strength and Gait in Children With Lower Limb Burns

October 11, 2023 updated by: Ragaee Saeed Mahmoud, South Valley University

Improvement by Isokinetic and Treadmill Training on Muscle Strength and Gait in Burned Children

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

To evaluate the efficacy of isokinetic training against treadmill training in improving muscle strength and gait in children having lower limb burns. Methods: Sixty children from both genders (boys and girls) who were complaining from 2nd degree lower limb burns with ≥30 percent of their total body surface area (TBSA) participated in this study, their ages ranged from 8 to 16 years and they were randomized into three groups of same number (A, B and C). Groups (A) received conventional physical therapy program, group (B) received the same conventional physical therapy program of group (A) with trained to use the isokinetic device while group (C) received the same conventional physical therapy program of group (A and B) and used treadmill training. The children participated in this study were assessed by Hand-held dynamometer (HHD) and Balance Master System (BMS). They were evaluated before and after the treatment program three sessions per week for 12 consecutive weeks.

Study Type

Interventional

Enrollment (Estimated)

60

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

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

  • Child

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

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: Conventional physical therapy group
It consisted of 20 children received conventional physical therapy program
Other: Conventional physical therapy
  • 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.
Other Names:
  • physical therapy program
Experimental: isokinetic training group
It consisted of 20 children received conventional physical therapy program and isokinetic training
Other: Conventional physical therapy
  • 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.
Other Names:
  • physical therapy program
Experimental: Treadmill training group
It consisted of 20 children received conventional physical therapy program and treadmill training
Other: Conventional physical therapy
  • 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.
Other Names:
  • physical therapy program

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Balance Master System
Time Frame: before intervention and after 12 weeks of intervention
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Hand-held dynamometer
Time Frame: before intervention and after 12 weeks of intervention
It is a portable device (Nicholas Manual Muscle Tester, Model 01160; Lafayette Instrument, Lafayette, IN), characterized as low-cost and convenient method
before intervention and after 12 weeks of intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

South Valley University

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 (Estimated)

October 15, 2023

Primary Completion (Estimated)

January 15, 2024

Study Completion (Estimated)

January 20, 2024

Study Registration Dates

First Submitted

September 2, 2023

First Submitted That Met QC Criteria

September 11, 2023

First Posted (Actual)

September 13, 2023

Study Record Updates

Last Update Posted (Actual)

October 13, 2023

Last Update Submitted That Met QC Criteria

October 11, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • REC/2111/MTI.PT/2204062

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

assessed before and after treatment

IPD Sharing Time Frame

12 weeks

IPD Sharing Access Criteria

accepted

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL

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.

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