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

Burned Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06036082
• Other study ID #: REC/2111/MTI.PT/2204062
• Status: Recruiting
• Phase: N/A
• Start date: October 15, 2023
• Est. completion date: January 20, 2024

Study information

• Verified date: October 2023
• Source: South Valley University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: January 20, 2024
• Est. primary completion date: January 15, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 8 Years to 16 Years

Eligibility

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.

Related Conditions & MeSH terms

• Burned
• Burns

Intervention

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.

Locations

Country	Name	City	State
Egypt	Ragaee Saeed Mahmoud	Faisal	Giza

Sponsors (1)

Lead Sponsor	Collaborator
South Valley University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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	before intervention and after 12 weeks of intervention