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

Primary Purpose

Burned

Status
Recruiting
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Conventional physical therapy
Sponsored by
South Valley University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Burned focused on measuring Burn; Children; Isokinetic Training; Treadmill Training

Eligibility Criteria

8 Years - 16 Years (Child)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Ragaee Saeed MahmoudRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Conventional physical therapy group

isokinetic training group

Treadmill training group

Arm Description

It consisted of 20 children received conventional physical therapy program

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Hand-held dynamometer
It is a portable device (Nicholas Manual Muscle Tester, Model 01160; Lafayette Instrument, Lafayette, IN), characterized as low-cost and convenient method

Full Information

First Posted
September 2, 2023
Last Updated
October 11, 2023
Sponsor
South Valley University
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1. Study Identification

Unique Protocol Identification Number
NCT06036082
Brief Title
Isokinetic Training Versus Treadmill Training on Muscle Strength and Gait in Children With Lower Limb Burns
Official Title
Improvement by Isokinetic and Treadmill Training on Muscle Strength and Gait in Burned Children
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 15, 2023 (Anticipated)
Primary Completion Date
January 15, 2024 (Anticipated)
Study Completion Date
January 20, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
South Valley University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Burned
Keywords
Burn; Children; Isokinetic Training; Treadmill Training

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
randomized control study
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Conventional physical therapy group
Arm Type
Experimental
Arm Description
It consisted of 20 children received conventional physical therapy program
Arm Title
isokinetic training group
Arm Type
Experimental
Arm Description
It consisted of 20 children received conventional physical therapy program and isokinetic training
Arm Title
Treadmill training group
Arm Type
Experimental
Arm Description
It consisted of 20 children received conventional physical therapy program and treadmill training
Intervention Type
Other
Intervention Name(s)
Conventional physical therapy
Other Intervention Name(s)
physical therapy program
Intervention Description
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.
Primary Outcome Measure Information:
Title
Balance Master System
Description
It is the most significant test to measure balance and has valid values of functional balance performance
Time Frame
before intervention and after 12 weeks of intervention
Secondary Outcome Measure Information:
Title
Hand-held dynamometer
Description
It is a portable device (Nicholas Manual Muscle Tester, Model 01160; Lafayette Instrument, Lafayette, IN), characterized as low-cost and convenient method
Time Frame
before intervention and after 12 weeks of intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
8 Years
Maximum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Facility Information:
Facility Name
Ragaee Saeed Mahmoud
City
Faisal
State/Province
Giza
ZIP/Postal Code
00202
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ragaee Mahmoud
Phone
00201223611112
Email
ragaeesaeedpt10@gmail.com
First Name & Middle Initial & Last Name & Degree
Reham Mahmoud
Phone
00201015447798
Email
rsm_211pt@yahoo.com

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
assessed before and after treatment
IPD Sharing Time Frame
12 weeks
IPD Sharing Access Criteria
accepted

Learn more about this trial

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

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