Comparing Effects of Whole Body Vibration and Resisted Tr... | NCT06801301

Studies
Comparing Effects of Whole Body Vibration and Resisted Training on Quadriceps Strength After Lower Limb Burns

NCT06801301

Sponsor

Cairo University

Status

Completed

Last Update Posted

Jan 30, 2025Actual

Enrollment

60Actual

Phase

Not Applicable

Conditions

Lower Limb Burn
Muscle Weakness Condition

Interventions

whole body vibration
Resistance Exercise

Countries

Egypt

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2025

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 1, 2023Actual

Primary Completion Date

Jul 1, 2024Actual

Completion Date

Aug 1, 2024Actual

First Submitted Date

Jan 20, 2025

First Submission Date that Met QC Criteria

Jan 24, 2025

First Posted Date

Jan 30, 2025Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 24, 2025

Last Update Posted Date

Jan 30, 2025Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

Detailed Description

Study Design:

This randomized controlled trial will include 60 patients suffering from partial thickness burns. The patients will be randomly divided into two equal groups, with each group consisting of 30 patients.

Study Explanation:

A verbal explanation about the importance of the study, its procedures, main aims, and conceptual approach will be provided to every patient.

Study Procedures:

The procedures of this study will be divided into two main categories: evaluation procedures and treatment procedures.

Evaluation Procedures:

Evaluation will be conducted using isokinetic dynamometry for all patients both before and after the study.

Treatment Procedures:

First Group: Patients in the first group will receive whole body vibration therapy.

Second Group: Patients in the second group will undergo resisted exercises.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

60Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
group A	Experimental	whole body vibration group	Device: whole body vibration
group B	Active Comparator	resistance exercises	Other: Resistance Exercise

Interventions

Name	Type	Description	Arm Group Labels	Other Names
whole body vibration	Device	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.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Increase in quadriceps muscle strength, assessed by an isokinetic dynamometer, which measures the peak torque of the quadriceps.		8 weeks

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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
Acute medical problem at study onset.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

25 Years

Maximum Age

40 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
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

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Faculty of physical therapy cairo university		Cairo	Egypt	12613	Egypt

IPD Sharing Statement Module

Plan to Share IPD

Yes

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

ID	Term
D002056	Burns

ID	Term
D014947	Wounds and Injuries

Intervention Browse Module

MeSH Terms

ID	Term
D055070	Resistance Training

Ancestor Terms

ID	Term
D005081	Exercise Therapy
D012046	Rehabilitation
D000359	Aftercare
D003266	Continuity of Patient Care

Browse Leaves

Not provided

Browse Branches

Not provided