- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica 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
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Descrizione dettagliata
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.
Tipo di studio
Iscrizione (Effettivo)
Fase
- Non applicabile
Contatti e Sedi
Luoghi di studio
-
-
-
Al Kharj, Arabia Saudita
- Prince Sattam Bin Abdulaziz University
-
-
Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
- Bambino
- Adulto
Accetta volontari sani
Descrizione
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.
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Separare
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
|
Sperimentale: 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.
|
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.
Altri nomi:
|
|
Comparatore attivo: 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.
|
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.
Altri nomi:
|
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Lower-Limb Muscle Strength
Lasso di tempo: pre-intervention (Week 0)
|
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
Lasso di tempo: immediately post-intervention (Week 12)
|
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)
|
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Vertical Jump Height
Lasso di tempo: pre-intervention (Week 0)
|
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.
|
pre-intervention (Week 0)
|
|
Vertical Jump Height
Lasso di tempo: immediately post-intervention (Week 12)
|
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.
|
immediately post-intervention (Week 12)
|
|
Broad Jump Distance
Lasso di tempo: pre-intervention (Week 0)
|
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.
|
pre-intervention (Week 0)
|
|
Broad Jump Distance
Lasso di tempo: immediately post-intervention (Week 12)
|
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.
|
immediately post-intervention (Week 12)
|
|
Reactive Strength Index
Lasso di tempo: pre-intervention (Week 0)
|
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.
|
pre-intervention (Week 0)
|
|
Reactive Strength Index
Lasso di tempo: immediately post-intervention (Week 12)
|
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.
|
immediately post-intervention (Week 12)
|
|
Lower Extremity Functional Scale Score
Lasso di tempo: pre-intervention (Week 0)
|
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.
|
pre-intervention (Week 0)
|
|
Lower Extremity Functional Scale Score
Lasso di tempo: immediately post-intervention (Week 12)
|
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.
|
immediately post-intervention (Week 12)
|
|
Six-Minute Walk Test Distance
Lasso di tempo: pre-intervention (Week 0)
|
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.
|
pre-intervention (Week 0)
|
|
Six-Minute Walk Test Distance
Lasso di tempo: immediately post-intervention (Week 12)
|
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.
|
immediately post-intervention (Week 12)
|
|
Timed Up and Down Stairs Performance
Lasso di tempo: pre-intervention (Week 0)
|
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.
|
pre-intervention (Week 0)
|
|
Timed Up and Down Stairs Performance
Lasso di tempo: immediately post-intervention (Week 12)
|
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.
|
immediately post-intervention (Week 12)
|
|
4×10-Meter Shuttle Run Time
Lasso di tempo: pre-intervention (Week 0)
|
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.
|
pre-intervention (Week 0)
|
|
4×10-Meter Shuttle Run Time
Lasso di tempo: immediately post-intervention (Week 12)
|
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.
|
immediately post-intervention (Week 12)
|
|
Figure-of-8 Walk/Run Test Time
Lasso di tempo: pre-intervention (Week 0)
|
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.
|
pre-intervention (Week 0)
|
|
Figure-of-8 Walk/Run Test Time
Lasso di tempo: immediately post-intervention (Week 12)
|
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.
|
immediately post-intervention (Week 12)
|
Collaboratori e investigatori
Sponsor
Collaboratori
Investigatori
- Direttore dello studio: Maged A Basha, PhD, Qassim University
Pubblicazioni e link utili
Pubblicazioni generali
- 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.
Studiare le date dei record
Studia le date principali
Inizio studio (Effettivo)
Completamento primario (Effettivo)
Completamento dello studio (Effettivo)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
- Manifestazioni neurologiche
- Malattie muscoloscheletriche
- Malattie del sistema nervoso
- Malattie muscolari
- Manifestazioni neuromuscolari
- Ferite e lesioni
- Processi patologici
- Condizioni patologiche, segni e sintomi
- Segni e sintomi
- Debolezza muscolare
- Brucia
- Attività motoria
- Movimento
- Fenomeni fisiologici muscoloscheletrici
- Fenomeni fisiologici muscoloscheletrici e neurali
- Terapie
- Modalità di terapia fisica
- Cura del paziente
- Terapia di esercizio
- Riabilitazione
- Assistenza post -terapia
- Continuità della cura del paziente
- Condizionamento fisico, umano
- Esercizio
- Esercizio pliometrico
Altri numeri di identificazione dello studio
- 2024-RHPT-017
Piano per i dati dei singoli partecipanti (IPD)
Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?
Descrizione del piano IPD
Periodo di condivisione IPD
Criteri di accesso alla condivisione IPD
Tipo di informazioni di supporto alla condivisione IPD
- STUDIO_PROTOCOLLO
Informazioni su farmaci e dispositivi, documenti di studio
Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti
Studia un dispositivo regolamentato dalla FDA degli Stati Uniti
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .