NCT05303181

Brief Summary

The study aims to investigate the effect of different Russian current parameters on maximum voluntary isometric contraction of the quadriceps muscle among University of Sharjah students.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for not_applicable quality-of-life

Timeline
Completed

Started May 2022

Status
unknown

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

February 22, 2022

Completed
1 month until next milestone

First Posted

Study publicly available on registry

March 31, 2022

Completed
1 month until next milestone

Study Start

First participant enrolled

May 8, 2022

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2022

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2023

Completed
Last Updated

March 31, 2022

Status Verified

March 1, 2022

Enrollment Period

8 months

First QC Date

February 22, 2022

Last Update Submit

March 21, 2022

Conditions

Outcome Measures

Primary Outcomes (1)

  • establish the relationship between the different carrier frequency for burst modulated electrical stimulation as an independent variable and electrical induced quadriceps femoris muscle torque (EIT) as a dependent variable.

    The primary outcome of the study is to establish the relationship between the different carrier frequency for burst modulated electrical stimulation as an independent variable and electrical induced quadriceps femoris muscle torque (EIT) as a dependent variable. And the effect of different RC mode on the electrical induce torque by the quadriceps muscle. The EIT measurement will be done using the Biodex pro 3 system devices this system was described in detail; with reliability and validity has been investigated previous study establish its reliable. This study, will investigate the effect of different carrier frequency 2500Hz-3750Hz-5000Hz alternating current on the electrical induce quadriceps muscle torque of the dominant leg, and the effect of different Russian current mode on the EIT of the quadriceps muscle femoris.

    measured data will be recorded at the 3rd week after training using RC and at 6th week as a follow up measurements

Study Arms (4)

Group1

EXPERIMENTAL

training used Russian Current carrier frequency at 2500-Hz alternating current.

Device: Russian Current

Group2

EXPERIMENTAL

training used Russian Current carrier frequency at 3750-Hz alternating current.

Device: Russian Current

Group3

EXPERIMENTAL

training used Russian Current carrier frequency at 5000-Hz alternating current.

Device: Russian Current

Group4

EXPERIMENTAL

training used Russian Current at different mode.

Device: Russian Current

Interventions

The patient will be placed in sitting position, hip at 90-degree flexion, knee at 60°, the upper body supported by the backrest, cross belt support the trunk and cross belt support the pelvis. The dynamometer rotating axis will be aligned with knee joint axis and the resistance lever arm will place in the distal leg above the malleolus. The angle of the joints adjustment considering the joint's range of motion and the device's user's manual, any movement other than the range of motion determined by the mechanical limit will be not allowed All electrical induced contraction will last 4 second each, with characteristics of 75 bursts; 4 second time on, 400 μs pulse width and 10 second time off. The greatest electrically induced torque by the quadriceps muscle at the maximum current output from the stimulator will be recorded for each subject to be used in data analysis. The same procedure will be done on the 3rd week and after 6th week.

Also known as: The Biodex isokinetic dynamometer
Group1Group2Group3Group4

Eligibility Criteria

Age18 Years - 25 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Their age ranged from 18 to 25 years.
  • Their Body Mass Index (BMI) within normal range (18.5-25).
  • Don't have any health related condition that required medical attention in the past two years.
  • All participant at same physical fitness level.

You may not qualify if:

  • The subjects will be excluded from this study if they have any of the following criteria:
  • Quadriceps muscle injury.
  • Spinal or lower limb fractures.
  • Lower limb deformities.
  • Associated cognition abnormalities which may to affect muscle and limb function
  • Tumors or radicular symptoms
  • Recent muscular lesion, knee injury, sensory changes and neuromuscular disease
  • Previous surgery that may affect the lower limb muscle performance.
  • Any contraindication for Russian current application

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
SUPPORTIVE CARE
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
principal investigator

Study Record Dates

First Submitted

February 22, 2022

First Posted

March 31, 2022

Study Start

May 8, 2022

Primary Completion

December 30, 2022

Study Completion

April 30, 2023

Last Updated

March 31, 2022

Record last verified: 2022-03

Data Sharing

IPD Sharing
Will not share

All information taken will be kept confidential and will not be taken without the participant's consent. Any data collected will be for scientific purpose only.The therapists have been instructed about the privacy, confidentiality and rights of the participants . Published data will remain anonymous without personal identifier of participants