- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07590557
Plyometrics for Strength and Function After Pediatric Burns
Rebuilding Capacity With Plyometrics: A Novel and Potent Stimulus for Strength and Power, and Functional Performance in Pediatric Post-Burn Population
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
This two-arm, parallel-group, single-blind randomized controlled trial included 62 pediatric burn survivors aged 10-18 years with severe burns involving ≥30% total body surface area and lower-limb involvement. Participants were recruited 6-12 months after hospital discharge and randomly allocated in a 1:1 ratio to either plyometric training or standard exercise.
Both groups received supervised exercise twice weekly for 12 weeks. The experimental group completed progressive plyometric exercises designed to enhance lower-extremity explosive power and dynamic functional mobility. The control group received standard post-discharge rehabilitation focused on flexibility, aerobic conditioning, mobility, and basic strengthening. Outcomes were assessed at baseline and immediately after the 12-week intervention by blinded assessors.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Al Kharj, Saudi Arabia
- Prince Sattam Bin Abdulaziz University
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Children and adolescents aged 10-18 years at the time of enrolment.
- History of severe burn injury involving ≥30% total body surface area (TBSA), with lower-extremity involvement.
- Between 6 and 12 months post-hospital discharge.
- Ability to understand study instructions and safely perform the prescribed exercise program.
Exclusion Criteria:
- Pre-existing neurological or musculoskeletal disorders that may affect lower-limb function or study outcomes.
- Severe lower-limb joint contracture limiting functional movement.
- Cognitive impairment preventing understanding of instructions or reliable participation.
- Participation in another structured exercise, rehabilitation, or physical therapy program outside the study protocol during the trial period.
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 |
|---|---|
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Experimental: Plyometric Training Group
Participants received a 12-week supervised plyometric training program, twice weekly, with each session lasting 45 minutes.
Sessions included dynamic warm-up, progressive plyometric exercises targeting vertical and horizontal force production, and cool-down.
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Participants in the plyometric training group will receive a 12-week supervised program, with each session lasting 45 minutes and designed to improve lower-extremity explosive power and dynamic functional mobility.
Sessions will include a 5-minute dynamic warm-up, 35 minutes of progressive plyometric exercises targeting vertical and horizontal force production, and a 5-minute cool-down.
Training will be individually supervised with safety measures including shock-absorbing flooring, cushioned footwear, technique monitoring, and standardized rest intervals.
Other Names:
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Active Comparator: Standard Exercise Group
Participants received a 12-week supervised standard exercise program, twice weekly, with each session lasting 45 minutes.
Sessions focused on flexibility, aerobic conditioning, mobility, and basic lower-limb strengthening.
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Participants in the control group will receive a 12-week supervised program, with each session lasting 45 minutes post-discharge burn rehabilitation program focusing on mobility, flexibility, aerobic conditioning, and basic lower-limb strengthening.
Sessions will include warm-up, stretching, moderate-intensity aerobic exercise at 50-70% of age-predicted maximum heart rate, strengthening exercises, and cool-down, with progression based on participant tolerance.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Lower-Limb Muscle Strength
Time Frame: pre-intervention (Week 0)
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Quadriceps and hamstring strength will be assessed using an isokinetic dynamometer.
After standardized positioning, stabilization, warm-up, and familiarization, participants will perform five maximal reciprocal knee extension/flexion repetitions.
The highest peak torque value (Nm) for hamstrings and quadriceps will be recorded.
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pre-intervention (Week 0)
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Lower-Limb Muscle Strength
Time Frame: immediately post-intervention (Week 12)
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Quadriceps and hamstring strength will be assessed using an isokinetic dynamometer.
After standardized positioning, stabilization, warm-up, and familiarization, participants will perform five maximal reciprocal knee extension/flexion repetitions.
The highest peak torque value (Nm) for hamstrings and quadriceps will be recorded.
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immediately post-intervention (Week 12)
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Vertical Jump Height
Time Frame: pre-intervention (Week 0)
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Vertical Jump Test: Lower-limb explosive power will be assessed using a vertical jump performed on a force plate.
Participants will jump maximally with hands on hips to minimize arm contribution, completing three trials with 60 seconds of rest between trials.
The highest jump height will be recorded in centimeters.
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pre-intervention (Week 0)
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Vertical Jump Height
Time Frame: immediately post-intervention (Week 12)
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Vertical Jump Test: Lower-limb explosive power will be assessed using a vertical jump performed on a force plate.
Participants will jump maximally with hands on hips to minimize arm contribution, completing three trials with 60 seconds of rest between trials.
The highest jump height will be recorded in centimeters.
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immediately post-intervention (Week 12)
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Broad Jump Distance
Time Frame: pre-intervention (Week 0)
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Horizontal lower-limb power and dynamic leg strength will be assessed using the broad jump test.
Participants will perform three maximal two-footed forward jumps from a marked starting line, with 60 seconds of rest between trials.
The longest distance, measured from the starting line to the rearmost landing point, will be recorded in centimeters.
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pre-intervention (Week 0)
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Broad Jump Distance
Time Frame: immediately post-intervention (Week 12)
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Horizontal lower-limb power and dynamic leg strength will be assessed using the broad jump test.
Participants will perform three maximal two-footed forward jumps from a marked starting line, with 60 seconds of rest between trials.
The longest distance, measured from the starting line to the rearmost landing point, will be recorded in centimeters.
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immediately post-intervention (Week 12)
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Reactive Strength Index
Time Frame: pre-intervention (Week 0)
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Reactive strength will be assessed using a drop jump from a 30-cm box onto a force plate.
Three trials will be performed with 60 seconds of rest, and the highest reactive strength index value, calculated as jump height divided by ground contact time, will be recorded.
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pre-intervention (Week 0)
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Reactive Strength Index
Time Frame: immediately post-intervention (Week 12)
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Reactive strength will be assessed using a drop jump from a 30-cm box onto a force plate.
Three trials will be performed with 60 seconds of rest, and the highest reactive strength index value, calculated as jump height divided by ground contact time, will be recorded.
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immediately post-intervention (Week 12)
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Lower Extremity Functional Scale Score
Time Frame: pre-intervention (Week 0)
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Lower-limb functional ability will be assessed using the 20-item Lower Extremity Functional Scale, which evaluates perceived difficulty in activities such as walking, running, stair climbing, and squatting.
Each item is scored from 0 to 4, with a total score ranging from 0 to 80. Higher scores indicate better functional capacity.
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pre-intervention (Week 0)
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Lower Extremity Functional Scale Score
Time Frame: immediately post-intervention (Week 12)
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Lower-limb functional ability will be assessed using the 20-item Lower Extremity Functional Scale, which evaluates perceived difficulty in activities such as walking, running, stair climbing, and squatting.
Each item is scored from 0 to 4, with a total score ranging from 0 to 80. Higher scores indicate better functional capacity.
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immediately post-intervention (Week 12)
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Six-Minute Walk Test Distance
Time Frame: pre-intervention (Week 0)
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Functional exercise capacity will be assessed using the Six-Minute Walk Test performed along a 30-meter indoor corridor according to standardized guidelines.
Participants will be instructed to walk as far as possible, without running, within six minutes, and the total distance covered will be recorded in meters.
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pre-intervention (Week 0)
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Six-Minute Walk Test Distance
Time Frame: immediately post-intervention (Week 12)
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Functional exercise capacity will be assessed using the Six-Minute Walk Test performed along a 30-meter indoor corridor according to standardized guidelines.
Participants will be instructed to walk as far as possible, without running, within six minutes, and the total distance covered will be recorded in meters.
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immediately post-intervention (Week 12)
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Timed Up and Down Stairs Performance
Time Frame: pre-intervention (Week 0)
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Lower-limb power, agility, and dynamic balance will be assessed using the Timed Up and Down Stairs test.
Participants will ascend and descend 10 standard stairs as quickly and safely as possible, with two trials performed and the fastest time recorded in seconds.
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pre-intervention (Week 0)
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Timed Up and Down Stairs Performance
Time Frame: immediately post-intervention (Week 12)
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Lower-limb power, agility, and dynamic balance will be assessed using the Timed Up and Down Stairs test.
Participants will ascend and descend 10 standard stairs as quickly and safely as possible, with two trials performed and the fastest time recorded in seconds.
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immediately post-intervention (Week 12)
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4×10-Meter Shuttle Run Time
Time Frame: pre-intervention (Week 0)
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Agility and speed will be assessed using the 4×10-meter shuttle run test.
Participants will run back and forth between two cones placed 10 meters apart, completing four 10-meter segments for a total distance of 40 meters.
Two trials will be performed, and the fastest completion time will be recorded in seconds.
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pre-intervention (Week 0)
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4×10-Meter Shuttle Run Time
Time Frame: immediately post-intervention (Week 12)
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Agility and speed will be assessed using the 4×10-meter shuttle run test.
Participants will run back and forth between two cones placed 10 meters apart, completing four 10-meter segments for a total distance of 40 meters.
Two trials will be performed, and the fastest completion time will be recorded in seconds.
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immediately post-intervention (Week 12)
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Figure-of-8 Walk/Run Test Time
Time Frame: pre-intervention (Week 0)
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Dynamic balance, agility, and coordination will be assessed using the Figure-of-8 Walk/Run Test.
Participants will complete two full loops around two cones placed 5 meters apart as quickly as possible.
Two trials will be performed, and the fastest completion time will be recorded in seconds.
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pre-intervention (Week 0)
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Figure-of-8 Walk/Run Test Time
Time Frame: immediately post-intervention (Week 12)
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Dynamic balance, agility, and coordination will be assessed using the Figure-of-8 Walk/Run Test.
Participants will complete two full loops around two cones placed 5 meters apart as quickly as possible.
Two trials will be performed, and the fastest completion time will be recorded in seconds.
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immediately post-intervention (Week 12)
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Study Director: Maged A Basha, PhD, Qassim University
Publications and helpful links
General Publications
- Rivas E, Herndon DN, Cambiaso-Daniel J, Rontoyanni VG, Porter C, Glover S, Suman OE. Quantification of an Exercise Rehabilitation Program for Severely Burned Children: The Standard of Care at Shriners Hospitals for Children(R)-Galveston. J Burn Care Res. 2018 Oct 23;39(6):889-896. doi: 10.1093/jbcr/iry001.
- Neriamparambil AJ, Sawhney R, Wong WL. Evidence-Based Management of Burns: A Narrative Review of Evolving Practices. Eur Burn J. 2025 Nov 10;6(4):59. doi: 10.3390/ebj6040059.
- Elnaggar RK, Osailan AM, Alsubaie SF, Moawd SA, Abd El-Nabie WA. Graded aerobic exercise (GAEx): An effective exercise regimen to improve cardio-respiratory fitness and physical and psychosocial functioning in children with burn sequelae of the chest. Burns. 2022 Mar;48(2):337-344. doi: 10.1016/j.burns.2021.05.004. Epub 2021 May 13.
- Knuth CM, Auger C, Jeschke MG. Burn-induced hypermetabolism and skeletal muscle dysfunction. Am J Physiol Cell Physiol. 2021 Jul 1;321(1):C58-C71. doi: 10.1152/ajpcell.00106.2021. Epub 2021 Apr 28.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
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
Keywords
Additional Relevant MeSH Terms
- Neurologic Manifestations
- Musculoskeletal Diseases
- Nervous System Diseases
- Muscular Diseases
- Neuromuscular Manifestations
- Wounds and Injuries
- Pathologic Processes
- Pathological Conditions, Signs and Symptoms
- Signs and Symptoms
- Muscle Weakness
- Burns
- Motor Activity
- Movement
- Musculoskeletal Physiological Phenomena
- Musculoskeletal and Neural Physiological Phenomena
- Therapeutics
- Physical Therapy Modalities
- Patient Care
- Exercise Therapy
- Rehabilitation
- Aftercare
- Continuity of Patient Care
- Physical Conditioning, Human
- Exercise
- Plyometric Exercise
Other Study ID Numbers
- 2024-RHPT-017
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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