IRCT | Comparison of the effects of transcranial direct current stimulation (M1 and DLPFC) on knee joint proprioception, balance, muscles activity, movement function and reaction time speed, after neuromuscular fatigue in female amateur athletes.

Protocol summary

Study aim: A comparison of the effects of tDCS focuses on M1 and DLPFC on knee joint proprioception, balance, muscle activity, and movement function, after neuromuscular fatigue in female amateur athletes.
Design: Clinical trial with a control group, with parallel groups, double-blind, randomized, phase 2 on 45 subjects. Random number generator software was used for randomization.
Settings and conduct: Subjects who meet the conditions to enter the study will be invited to the study. After that, the demographic characteristics of the subjects and the results of the study will be evaluated in the pre-test. The warm-up process will be performed by running on a treadmill for 10 minutes at a selected speed. Then the neuromuscular fatigue protocol will be applied and immediately the results of the study will be re-evaluated in the pre-test. Next, transcranial direct current stimulation will be applied for 5 consecutive days. On the seventh day, the neuromuscular fatigue protocol will be applied again and the results of the study will be evaluated immediately.
Participants/Inclusion and exclusion criteria: Entry: Woman with regular sports activity in ball fields Prohibition of entry: injury in the trunk and lower limbs, mental problems and epilepsy, presence of metal parts in the forehead or neck
Intervention groups: In this research, stimulation of 1M and DLPFC regions will be used in experimental groups and deceptive stimulation in the control group. In sham stimulation mode, after 30 seconds of active stimulation, the electric current will be cut off and will remain so until the end. After installing the electrodes, the subjects will receive anodal electrical stimulation with an intensity of 2 milliamperes for 20 minutes in sitting conditions and without any verbal communication.
Main outcome variables: Knee joint proprioception, balance, muscles activity, movement function and reaction time speed

General information

Reason for update
Acronym
IRCT registration information: IRCT registration number: IRCT20240513061781N1

Registration date: 2024-11-18, 1403/08/28

Registration timing: prospective

Last update: 2024-11-18, 1403/08/28

Update count: 0
Registration date: 2024-11-18, 1403/08/28

Registrant information: Name

Samaneh Valadbeigi

Name of organization / entity

Razi University

Country

Iran (Islamic Republic of)

Phone

+98 83 4522 6988

Email address

s.valadbaigi@stu.razi.ac.ir

Recruitment status: Recruitment complete
Funding source

Expected recruitment start date: 2024-12-21, 1403/10/01
Expected recruitment end date: 2025-03-20, 1403/12/30
Actual recruitment start date: empty
Actual recruitment end date: empty
Trial completion date: empty

Scientific title: Comparison of the effects of transcranial direct current stimulation (M1 and DLPFC) on knee joint proprioception, balance, muscles activity, movement function and reaction time speed, after neuromuscular fatigue in female amateur athletes.

Public title: Investigating the effect of TDCS on knee proprioception, balance, muscle EMG, movement function and reaction time speed, after neuromuscular fatigue.
Purpose: Prevention
Inclusion/Exclusion criteria: Inclusion criteria:

Having regular sports activity. Sports fields with jumping-landing skills or changing direction.

Exclusion criteria:

Having a history of injury in the trunk and lower limbs in the last six months. Skeletal-muscular diseases. visual, vestibular (such as vertigo) or sensory (such as diabetes) disorders. People with mental problems and epilepsy. Use of neuroleptics.
Age: From 18 years old to 30 years old
Gender: Female

Phase

3

Groups that have been masked

Participant
Investigator
Outcome assessor

Sample size

Target sample size: 45

Randomization (investigator's opinion)

Randomized

Randomization description

Subjects will be randomly assigned to one of the experimental or control groups based on the output of the random number generator software by a person not involved in the research. The sequentially numbered opaque sealed envelope (SNOSE) method will hide the allocation.

Blinding (investigator's opinion)

Double blinded

Blinding description

Subjects and outcome assessors will not be aware of the assigned group. The random assignment of subjects to groups is done by a person not involved in the research, and the assigned group for each subject is placed in a sealed envelope and will be available to the laboratory expert. After evaluating the results of the study before the test, each subject will be provided with the envelope related to the person applying the stimuli, in this way, neither the subject nor the evaluator will be informed of the type of intervention.

Placebo

Used

Assignment

Parallel

Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee: Name of ethics committee

Research Ethics Committee of Kermanshah Razi University

Street address

Zakariya Razi Blvd, Kermanshah, Kermanshah Province

City

Kermanshah

Province

Kermanshah

Postal code

6714414971
Approval date: 2024-04-17, 1403/01/29
Ethics committee reference number: IR.RAZI.REC.1403.007

Health conditions studied

1

Description of health condition studied: Controlling the effect of fatigue on factors such as balance, proprioception, electrical activity of the muscles acting on the knee and movement performance
ICD-10 code: Injury to
ICD-10 code description: S83.7

Primary outcomes

1

Description: Degree of knee joint proprioception
Timepoint: Proprioceptive measurement at the beginning of the study and 7 days after the tDCS stimulation intervention
Method of measurement: goniometer

2

Description: Balance check
Timepoint: Balance measurement at the beginning of the study and 7 days after the tDCS stimulation intervention
Method of measurement: Y-Balance test

Secondary outcomes

1

Description: Electrical activity of knee muscles
Timepoint: Examining the electrical activity of the knee muscles at the beginning of the study and 7 days after applying tDCS stimulation intervention
Method of measurement: Noraxon electromyography device

Intervention groups

1

Description: The first Intervention group: receiving tDCS stimulation of the M1 point, with a current intensity of 2 mA for 20 minutes in each session with a number of 5 sessions.
Category: Prevention

2

Description: The second Intervention group: Intervention group: receiving tDCS stimulation of the DLPFC point, with a current intensity of 2 mA for 20 minutes in each session with a number of 5 sessions.
Category: Prevention

3

Description: Control group: Sham (inactive) tDCS stimulation, after 30 seconds of active stimulation, the electric current is cut off until the end of 20 minutes.
Category: Placebo

Recruitment centers

1

Recruitment center: Name of recruitment center

Razi University

Full name of responsible person

Samaneh Valadbeigi

Street address

Zakariya Razi Blvd, Kermanshah

City

Kermanshah

Province

Kermanshah

Postal code

6714414971

Phone

+98 83 3427 7605

Fax

Email

s.valadbeigi.99@gmail.com

1

Sponsor: Name of organization / entity

Razi University

Full name of responsible person

Nabi Ahmadi

Street address

Zakariya Razi Blvd, Kermanshah

City

kermanshH

Province

Kermanshah

Postal code

6714414971

Phone

+98 83 3427 7605

Email

s.valadbeigi.99@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?: Yes
Title of funding source: Razi University
Proportion provided by this source: 100
Public or private sector: Public
Domestic or foreign origin: Domestic
Category of foreign source of funding: empty
Country of origin
Type of organization providing the funding: Academic

Person responsible for general inquiries

Contact: Name of organization / entity

Razi University

Full name of responsible person

Samaneh Valadbeigi

Position

Student

Latest degree

Bachelor

Other areas of specialty/work

Sport pathology

Street address

Madreseh Ave, Fathoalmobin Blvd, Amirabad

City

Eslamabad Gharb

Province

Kermanshah

Postal code

6761111478

Phone

+98 83 4522 6988

Fax

Email

s.valadbaigi@stu.razi.ac.ir

Person responsible for scientific inquiries

Contact: Name of organization / entity

Razi University

Full name of responsible person

Samaneh Valadbeigi

Position

Student

Latest degree

Bachelor

Other areas of specialty/work

Sport pathology

Street address

Madreseh Ave, Fathoalmobin Blvd, Amirabad

City

Eslamabad Gharb

Province

Kermanshah

Postal code

6761111478

Phone

+98 83 4522 6988

Fax

Email

s.valadbaigi@stu.razi.ac.ir

Person responsible for updating data

Contact: Name of organization / entity

Razi University

Full name of responsible person

Samaneh Valadbeigi

Position

Student

Latest degree

Bachelor

Other areas of specialty/work

Sport pathology

Street address

Madreseh Ave, Fathoalmobin Blvd, Amirabad

City

Eslamabad Gharb

Province

Kermanshah

Postal code

6761111478

Phone

+98 83 4522 6988

Fax

Email

s.valadbaigi@stu.razi.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD): Yes - There is a plan to make this available
Study Protocol: Yes - There is a plan to make this available
Statistical Analysis Plan: Not applicable
Informed Consent Form: Yes - There is a plan to make this available
Clinical Study Report: Not applicable
Analytic Code: Not applicable
Data Dictionary: Not applicable
Title and more details about the data/document: Information about study outcomes will be shared.
When the data will become available and for how long: The access period starts 6 months after the results are published
To whom data/document is available: Researchers working in academic institutions
Under which criteria data/document could be used: Research in the relevant work area
From where data/document is obtainable: Samaneh Valadbeigi - s.valadbeigi.99@gmail.com
What processes are involved for a request to access data/document: Sending the request from the applicant, checking it from the researcher and responding immediately
Comments

Comparison of the effects of transcranial direct current stimulation (M1 and DLPFC) on knee joint proprioception, balance, muscles activity, movement function and reaction time speed, after neuromuscular fatigue in female amateur athletes.