NCT07590557

Brief Summary

Pediatric burn survivors may experience persistent deficits in lower-limb strength, explosive power, and functional performance after hospital discharge. This randomized controlled trial evaluated whether a 12-week supervised plyometric training program improves lower-extremity muscle strength, power, and functional capacity compared with a standard exercise program in children and adolescents with severe burn injuries.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
62

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2024

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2024

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 25, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 25, 2025

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

May 10, 2026

Completed
5 days until next milestone

First Posted

Study publicly available on registry

May 15, 2026

Completed
Last Updated

May 15, 2026

Status Verified

May 1, 2026

Enrollment Period

12 months

First QC Date

May 10, 2026

Last Update Submit

May 10, 2026

Conditions

Keywords

Pediatric burnsRehabilitationPlyometric trainingMuscle strengthMuscle powerFunctional performance

Outcome Measures

Primary Outcomes (2)

  • Lower-Limb Muscle Strength

    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.

    pre-intervention (Week 0)

  • Lower-Limb Muscle Strength

    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.

    immediately post-intervention (Week 12)

Secondary Outcomes (16)

  • Vertical Jump Height

    pre-intervention (Week 0)

  • Vertical Jump Height

    immediately post-intervention (Week 12)

  • Broad Jump Distance

    pre-intervention (Week 0)

  • Broad Jump Distance

    immediately post-intervention (Week 12)

  • Reactive Strength Index

    pre-intervention (Week 0)

  • +11 more secondary outcomes

Study Arms (2)

Plyometric Training Group

EXPERIMENTAL

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.

Other: Plyometric Training

Standard Exercise Group

ACTIVE COMPARATOR

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.

Other: Standard Exercise Program

Interventions

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.

Also known as: Plyo-Tr group
Plyometric Training Group

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.

Also known as: Control Intervention
Standard Exercise Group

Eligibility Criteria

Age10 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Prince Sattam bin Abdulaziz University

Al Kharj, Saudi Arabia

Location

Related Publications (4)

  • 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.

    PMID: 29596648BACKGROUND
  • 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.

    PMID: 41283468BACKGROUND
  • 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.

MeSH Terms

Conditions

BurnsMuscle Weakness

Interventions

Plyometric Exercise

Condition Hierarchy (Ancestors)

Wounds and InjuriesMuscular DiseasesMusculoskeletal DiseasesNeuromuscular ManifestationsNeurologic ManifestationsNervous System DiseasesPathologic ProcessesPathological Conditions, Signs and SymptomsSigns and Symptoms

Intervention Hierarchy (Ancestors)

Exercise TherapyRehabilitationAftercareContinuity of Patient CarePatient CareTherapeuticsPhysical Therapy ModalitiesPhysical Conditioning, HumanExerciseMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Maged A Basha, PhD

    Qassim University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Participants were randomized 1:1 to plyometric training or standard exercise for 12 weeks. Outcome assessors were blinded to group allocation.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor of Physical Therapy

Study Record Dates

First Submitted

May 10, 2026

First Posted

May 15, 2026

Study Start

April 1, 2024

Primary Completion

March 25, 2025

Study Completion

March 25, 2025

Last Updated

May 15, 2026

Record last verified: 2026-05

Data Sharing

IPD Sharing
Will share

De-identified individual participant data supporting the published results will be available from the corresponding author upon reasonable request.

Shared Documents
STUDY PROTOCOL
Time Frame
6 months after publication
Access Criteria
Requests will be reviewed for scientific relevance, methodological quality, and approval by all co-authors. Data will be shared after approval and, if required, completion of a data-sharing agreement.

Locations