- ICH GCP
- Rejestr badań klinicznych w USA
- Badanie kliniczne 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
Przegląd badań
Status
Warunki
Interwencja / Leczenie
Szczegółowy opis
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.
Typ studiów
Zapisy (Rzeczywisty)
Faza
- Nie dotyczy
Kontakty i lokalizacje
Lokalizacje studiów
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Al Kharj, Arabia Saudyjska
- Prince Sattam Bin Abdulaziz University
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Kryteria uczestnictwa
Kryteria kwalifikacji
Wiek uprawniający do nauki
- Dziecko
- Dorosły
Akceptuje zdrowych ochotników
Opis
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.
Plan studiów
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Leczenie
- Przydział: Randomizowane
- Model interwencyjny: Przydział równoległy
- Maskowanie: Pojedynczy
Broń i interwencje
Grupa uczestników / Arm |
Interwencja / Leczenie |
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Eksperymentalny: 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.
Inne nazwy:
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Aktywny komparator: 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.
Inne nazwy:
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Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
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Lower-Limb Muscle Strength
Ramy czasowe: 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
Ramy czasowe: 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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Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
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Vertical Jump Height
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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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Współpracownicy i badacze
Sponsor
Współpracownicy
Śledczy
- Dyrektor Studium: Maged A Basha, PhD, Qassim University
Publikacje i pomocne linki
Publikacje ogólne
- 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.
Daty zapisu na studia
Główne daty studiów
Rozpoczęcie studiów (Rzeczywisty)
Zakończenie podstawowe (Rzeczywisty)
Ukończenie studiów (Rzeczywisty)
Daty rejestracji na studia
Pierwszy przesłany
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy wysłany (Rzeczywisty)
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia weryfikacja
Więcej informacji
Terminy związane z tym badaniem
Słowa kluczowe
Dodatkowe istotne warunki MeSH
- Objawy neurologiczne
- Choroby układu mięśniowo-szkieletowego
- Choroby Układu Nerwowego
- Choroby mięśni
- Manifestacje nerwowo-mięśniowe
- Rany i urazy
- Procesy patologiczne
- Stany patologiczne, oznaki i objawy
- Objawy i symptomy
- Słabe mięśnie
- Oparzenia
- Aktywność motoryczna
- Ruch
- Physiologiczne zjawiska mięśniowo -szkieletowe
- Zjawiska fizjologiczne mięśniowo -szkieletowe i nerwowe
- Lecznictwo
- Fizjoterapia
- Opieka nad pacjentem
- Terapia ćwiczeń
- Rehabilitacja
- Opieka postpenitencjarna
- Ciągłość opieki nad pacjentem
- Kondycjonowanie fizyczne, człowiek
- Ćwiczenia
- Ćwiczenie plyometryczne
Inne numery identyfikacyjne badania
- 2024-RHPT-017
Plan dla danych uczestnika indywidualnego (IPD)
Planujesz udostępniać dane poszczególnych uczestników (IPD)?
Opis planu IPD
Ramy czasowe udostępniania IPD
Kryteria dostępu do udostępniania IPD
Typ informacji pomocniczych dotyczących udostępniania IPD
- PROTOKÓŁ BADANIA
Informacje o lekach i urządzeniach, dokumenty badawcze
Bada produkt leczniczy regulowany przez amerykańską FDA
Bada produkt urządzenia regulowany przez amerykańską FDA
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