- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07832955
Response of Muscle Mechanical Properties to Early Multi-angles Isometric Exercises in Acute Burn Patients (ABP)
This study will be conducted to investigate the effect of early multi-angle isometric exercise on muscle properties in post-burn patients.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
A burn injury represents the fourth most common type of trauma globally, though it is associated with the most devastating consequences Severe burn injuries, encompassing ≥20% of the total body surface area (TBSA) in adults, present a unique challenge compared with other forms of trauma given the magnitude and persistence of systemic dysregulation.Burns can occur when the skin is exposed to heat sources, such as flames, flash burns, hot objects, grease, scald, chemicals, and electricity Burn injuries are highly variable, as is their severity. The patient's comorbidities can influence the burn's clinical outcome. Additionally, morbidity and mortality tend to increase as the surface area of the burn increases .Isometric exercise is a static form of exercise in which a muscle contracts and produces force without an appreciable change in the length of the muscle and without visible joint motion. Although there is no mechanical work done (force × distance), a measurable amount of tension and force output are produced by the muscle. Sources of resistance for isometric exercise include holding against a force applied manually, holding a weight in a particular position, maintaining a position against the resistance of body weight, or pushing or pulling an immovable object.Although post-burn muscle wasting is widely recognized, it is not consistently targeted as a primary rehabilitation outcome during the acute phase of care. Furthermore, there is a lack of randomized controlled trials examining the effects of early Multi- angle isometric exercise on objective measures of muscle mechanical properties in acute burn patients using sensitive technology like the MyotonPRO.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Vivian Essam Sadek Halim, master
- Phone Number: +20 12 82747190
- Email: vivianessam123@gmail.com
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Male and female patients aged 20 to 40 years
- Patients diagnosed with acute burns.
- Total Body Surface Area (TBSA) ranging from 15% to 30%, 2nd degree burn patients.
- Medically stable patients.
- Patients within the first 4 weeks post-burn (acute stage).
- Burns affecting lower limb muscles (Quadriceps, Hamstring , and calf muscles ) .
Exclusion Criteria:
- Patients with third-degree burns requiring immediate surgical grafting at the assessment site.
- Patients with associated fractures or neurological disorders.
- Patients with severe cardiopulmonary instability.
- Patients under mechanical ventilation.
- Patients with systemic diseases affecting muscle properties (e.g., neuromuscular disorders).
Study Plan
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: isometric exercise program
20 patients will receive early Multi-angle isometric exercise program in addition to conventional physical therapy 3 times per week for 3 weeks. |
isometric exercises targeting the affected muscle groups Lower limb muscles. Exercises will begin within the first week post-burn after medical stabilization, Isometric contractions will be performed at submaximal intensity (approximately 50-60% of maximum voluntary contraction).Each contraction will be held for 5-10 seconds followed by 10 seconds of relaxation. Each muscle group will perform 10 repetitions per set in addition to conventional physical therapy Conventional physical therapy programs include positioning, mobilization, range of motion exercises, stretching and splinting |
|
Active Comparator: conventional physical therapy
20 patients will receive conventional physical therapy 3 times per week for 3 weeks. |
Conventional physical therapy programs include positioning, mobilization, range of motion exercises, stretching and splinting |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
muscle dynamic stiffness
Time Frame: up to 3 weeks
|
The MyotonPro (Myoton AS Tallinn, Estonia) device will be used to assess muscle dynamic stiffness. it introduces an innovative and non-invasive approach for comprehensively characterizing the biomechanical and viscoelastic properties of muscles.The device is applied under constant preload (0.18 N) to pre-compress subcutaneous tissues, and it exerts a brief (15 milliseconds) mechanical tap at a pre-determined force (0.4 Newtons), followed by quick release, causing damped oscillations that are recorded by the testing probe. This device is portable, inexpensive, easy to use, and convenient for re-cording the biomechanical and viscoelastic stiffness of myofascial tissues relatively quickly.A higher dynamic stiffness indicates greater resistance to force application. |
up to 3 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
lower limb disability
Time Frame: up to 3 weeks
|
The Lower Extremity Functional Scale (LEFS) is a patient-reported outcome measure which assesses the functional status of patients who have lower extremity conditions of musculoskeletal origin. The 20-item questionnaire inquires as to the degree of difficulty of performance of each of these activities on a 5-point Likert scale and a score of 80 represents an individula with normal functions |
up to 3 weeks
|
|
oscillatory frequency
Time Frame: up to 3 weeks
|
The MyotonPro (Myoton AS Tallinn, Estonia) device will be used to assess oscillation frequency. it introduces an innovative and non-invasive approach for comprehensively characterizing the biomechanical and viscoelastic properties of muscles.The device is applied under constant preload (0.18 N) to pre-compress subcutaneous tissues, and it exerts a brief (15 milliseconds) mechanical tap at a pre-determined force (0.4 Newtons), followed by quick release, causing damped oscillations that are recorded by the testing probe. This device is portable, inexpensive, easy to use, and convenient for re-cording the biomechanical and viscoelastic stiffness of myofascial tissues relatively quickly.A higher oscillation frequency indicates higher muscle tone, while increased stiffness reflects greater resistance to force application. |
up to 3 weeks
|
|
muscle elasticity
Time Frame: up to 3 weeks
|
the MyotonPro (Myoton AS Tallinn, Estonia) device will be used to assess muscle elasticity. it quantifies the dissipation of mechanical energy (damping) during natural oscillations of a muscle. lower values signify higher elasticity (i.e., better ability to recover from deformation), while higher values suggest lower elasticity. |
up to 3 weeks
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- P.T.REC/012/006564
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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