NCT06801301

Brief Summary

Evaluate the therapeutic effect of Whole body vibration and Resistance training on strength of quadriceps post lower limb burn

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2023

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2023

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2024

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2024

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

January 20, 2025

Completed
10 days until next milestone

First Posted

Study publicly available on registry

January 30, 2025

Completed
Last Updated

January 30, 2025

Status Verified

January 1, 2025

Enrollment Period

1.2 years

First QC Date

January 20, 2025

Last Update Submit

January 24, 2025

Conditions

Keywords

BurnWhole Body VibrationResisted ExerciseIsokinetic

Outcome Measures

Primary Outcomes (1)

  • Increase in quadriceps muscle strength, assessed by an isokinetic dynamometer, which measures the peak torque of the quadriceps.

    8 weeks

Study Arms (2)

group A

EXPERIMENTAL

whole body vibration group

Device: whole body vibration

group B

ACTIVE COMPARATOR

resistance exercises

Other: Resistance Exercise

Interventions

Standing in different static positions or exercising on a vibrating platform.The mechanical stimuli of vibration transmitted to the body and stimulate muscle spindles which activate the alpha motor neurons and initiates muscle contractions comparable to the ''tonic vibration reflex. The effect of WBV on the neuromuscular properties of skeletal muscles and spinal mechanisms is demonstrated by a decreased electromechanical delay.

group A

Resistance training as a mode of exercise to promote several health benefits, including improvements in the muscle mass and strength of healthy adults.Resistance training, where muscles are required to contract against an opposing load, has been shown to be a beneficial form of rehabilitation in clinical populations prone to muscle wasting, providing stimuli to increase protein synthesis and muscle mass.

group B

Eligibility Criteria

Age25 Years - 40 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • The subject selection will be according to the following criteria:
  • Age range between 25-40 years.
  • Male and female patients will participate in the study.
  • All patients have burn of 30% to 40%.
  • All patients have burn at lower limb
  • All patients have second degree burn
  • All patients have no chronic diseases.
  • All patients enrolled to the study will have their informed consent

You may not qualify if:

  • The potential participants will be excluded if they meet one of the following criteria:
  • Prosthesis;
  • Any neurological, musculoskeletal,or other chronic disease
  • Participation in an outside resistance training programs
  • Recent fracture or bone injury
  • Any medication that could affect strength adaptations and adversely affect the results of the study
  • Previous brain injury
  • Any disease affecting balance, vestibular or visual disorders
  • History of epilepsy.
  • Cardiac diseases.
  • Burn of sole of foot.
  • Exposed foot tendons.
  • Severe osteopathy.
  • Marked anemia (Ht\<25%).
  • Serious peripheral vessel disease
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of physical therapy cairo university

Cairo, Egypt, 12613, Egypt

Location

MeSH Terms

Conditions

Burns

Interventions

Resistance Training

Condition Hierarchy (Ancestors)

Wounds and Injuries

Intervention Hierarchy (Ancestors)

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

Study Officials

  • Eman Mohamed Othman, doctoral degree

    Cairo University

    STUDY DIRECTOR
  • Khadra Mohamed Ali, Doctoral degree

    Cairo University

    STUDY CHAIR
  • Ashraf El Sebaie Mohamed, doctoral

    Cairo University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Physiotherapy Specialist

Study Record Dates

First Submitted

January 20, 2025

First Posted

January 30, 2025

Study Start

May 1, 2023

Primary Completion

July 1, 2024

Study Completion

August 1, 2024

Last Updated

January 30, 2025

Record last verified: 2025-01

Data Sharing

IPD Sharing
Will share

Locations