NCT06932913

Brief Summary

The aim of this study is to investigate the effect of plyometric exercise on improving lower limb function after a pediatric burn. Hypothesis: It will be hypothesized that: There will be no effect of plyometric exercise on changing lower limb functions after pediatric burn . 52 children with lower limb burn will participate in this study will receive traditional physical therapy program in the form of range of motion exercises , stretching, and strengthen exercises 3 sessions per week, eight successive weeks. will receive plyometric exercise and traditional physical therapy program for 3 sessions per week, eight successive weeks . Measuring Equipment:

  • Goniometer: for measuring knee flexion ROM
  • Hand-held dynamometer for measuring of hamstring muscle strength
  • Lower Extremity Functional Scale (LEFS)

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
52

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 10, 2025

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 17, 2025

Completed
8 days until next milestone

Study Start

First participant enrolled

April 25, 2025

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 25, 2025

Completed
5 days until next milestone

Study Completion

Last participant's last visit for all outcomes

July 30, 2025

Completed
Last Updated

April 17, 2025

Status Verified

February 1, 2025

Enrollment Period

3 months

First QC Date

April 10, 2025

Last Update Submit

April 10, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • knee flexion ROM

    The universal goniometer (Whitehall Manufacturing, City of Industry, CA, USA) has a transparent plastic 360° face, two movable arms, and a 1° gradation.

    measurements will be obtained before starting the treatment protocol then after one month of treatment as post I, and at the end of the treatment protocol after two months as post Post II

Secondary Outcomes (2)

  • Hand held dynamometer for measuring strength:

    measurements will be obtained before starting the treatment protocol then after one month of treatment as post I, and at the end of the treatment protocol after two months as post Post II .

  • Lower Extremity Functional Scale (LEFS)

    measurements will be obtained before starting the treatment protocol then after one month of treatment as post I, and at the end of the treatment protocol after two months as post Post II .

Study Arms (2)

Group A (control):

ACTIVE COMPARATOR

This group will be composed of 26 patients and will receive traditional physical therapy program in the form of range of motion exercises , stretching, and strengthen exercises 3 sessions per week, eight successive weeks.

Other: Plyometric exercise procedures:

Group B (plyometric exercise):

EXPERIMENTAL

This group will be composed of 26 patients and will receive plyometric exercise and traditional physical therapy program for 3 sessions per week, eight successive weeks .

Other: plyometric exerciseOther: Plyometric exercise procedures:

Interventions

Plyometric exercise procedures: Patients in group (B) will receive Plyometric exercise : Traditional physical therapy program for 20 to 30 minutes and 30 to 45 minutes of training program consisted of 6 lower extremity plyometric exercises for eight weeks . Wall jumps : Knees slightly bent, arms raised overhead, bounce up and down off toes . Tuck jumps : From standing position, jump and bring both knees up to chest as high as possible Squat jumps : Standing jump raising both arms overhead, land in squatting position touching both hands to the floor Single leg jump distance : One-legged hop for distance . Scissors jump : Start in stride position, jump and alternate position in midair . Bounding in place : Jump from 1 leg to the other straight up and down.

Group B (plyometric exercise):

The traditional physical therapy program will be in the form of (active knee range of motion exercise and stretching and strengthen exercise of hamstring) three times a week for eight successive weeks of treatment in 20 to 30 minutes to complete:- Active range of motion exercises for knee joint: This type of exercise was performed in the following manner: Knee flexion : From prone lying position. The child will asked to Slowly bend his knee by pulling heel to buttocks as far as he can . he should feel a gentle stretch in his thigh muscles and knee. Return to starting position. Knee extension : From sitting position at the edge of the plinth the child will asked to move his feet up word toward the ceiling as far as he can then return . he should feel gentle stretch on the hamstring muscle . Hip and knee bend:

Group A (control):Group B (plyometric exercise):

Eligibility Criteria

Age7 Years - 15 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • age ranges from 7 to 15 years old. Patients with posterior lower limb burn involving hamstring. Total surface area affected equals 3 to 10 percent . Healed Second degree burn child. Knee joint ROM is affected .

You may not qualify if:

  • Concomitant Psychiatric disorders including major depression, anxiety, or personality disorders.
  • Patients with fractures and joint injuries . Patients with neurological problems . Any traumatic or infectious condition that involve the affected lower limb. Sever Cardiac diseases. Deep third or forth degree burns .

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

faculty of physical therapy, Cairo University

Cairo, Cairo Governorate, P.O.Box 11432, Egypt

Location

MeSH Terms

Interventions

Plyometric Exercise

Intervention Hierarchy (Ancestors)

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

Central Study Contacts

HISHAM M ABOUELSOUD, MSc

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
only participants are blinded
Purpose
TREATMENT
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

April 10, 2025

First Posted

April 17, 2025

Study Start

April 25, 2025

Primary Completion

July 25, 2025

Study Completion

July 30, 2025

Last Updated

April 17, 2025

Record last verified: 2025-02

Data Sharing

IPD Sharing
Will not share

it will be available when needed

Locations