The aim of this study is to determine the effect of neurofeedback and neuromuscular training on fluctuations in the center of pressure, balance and proprioception sense of the ankle joint in table tennis players with chronic ankle instability.
Design
Double Blind Randomized Clinical Trial
Settings and conduct
A total of 30 elite male table tennis players with chronic ankle instability were randomly assigned to two groups of neuromuscular training and combination training (neurofeedback + neuromuscular) and do exercises related to their group for eight weeks. Pre-test and post-test (after eight weeks of training) data were recorded and will be analyzed.
Participants/Inclusion and exclusion criteria
The inclusion criteria in this study were based on the International Ankle Consortium. Inclusion criteria for CAI subjects' disorders were acute ankle sprain leading to swelling, pain, and loss of functional activity for at least one day, giving way at least twice in the past six months, getting a score of less than 24 on the Cumberland Ankle Instability Tool, and getting a score of more than 5 on the ankle instability instrument. All participants in this study were members of the national team or champions in different age categories of adolescents, youth and adults. Exclusion criteria were lower limb injury, back pain or concussion in the six months prior to the study, neurological and postural disorders, history of fracture or lower limb surgery, and history of taking anti-depressants, anti-anxiety drugs and narcotics. An orthopedic specialist performed examinations to confirm participants' chronic ankle instability for the study.
Intervention groups
Neuromascular group Combination (neuromascular with neurofeedback) group
Main outcome variables
Neuromascular and Neurofeedback Training
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20211018052799N1
Registration date:2021-12-01, 1400/09/10
Registration timing:retrospective
Last update:2021-12-01, 1400/09/10
Update count:0
Registration date
2021-12-01, 1400/09/10
Registrant information
Name
Masoud Azizian
Name of organization / entity
The University of Bu-ali sina Hamedan
Country
Iran (Islamic Republic of)
Phone
+98 81 3826 5636
Email address
m.azizian@phe.basu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-10-23, 1400/08/01
Expected recruitment end date
2021-11-22, 1400/09/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of Neuromuscular and Neurofeedback Training on Balance and Plantar Pressure Variables of Table Tennis Players with Chronic Ankle Instability
Public title
Effect of Neuromuscular and Neurofeedback Training on Chronic Ankle Instability
Purpose
Screening
Inclusion/Exclusion criteria
Inclusion criteria:
One year before the present intervention, they suffered from lateral ankle sprain injury.Activity of the participants.
A score of 24 or higher on the Cumberland Questionnaire (Ankle Instability Assessment Tool)
Exclusion criteria:
No surgery, fractures or serious injuries to the ankle and lower limbs.
No cardiovascular and respiratory diseases
No smoking
Lack of pes planus, pes cavus and hallux valgus
Absence of deformity in the thoracic, cervical, pelvic, lumbar and lower extremities
Lack of diabetes and diseases related to peripheral nerves
No history of using any type of shoe or medical shoe,
Do not use artificial limbs on the femur, knee and ankles
Age
From 18 years old to 25 years old
Gender
Male
Phase
N/A
Groups that have been masked
Participant
Data analyser
Sample size
Target sample size:
30
Randomization (investigator's opinion)
Randomized
Randomization description
Participants were randomly divided into two groups of 15 people (neurofeedback and neuromuscular) and neuromuscular group using Random Number Generator software.
Blinding (investigator's opinion)
Double blinded
Blinding description
In this study, both the examiner and the participants were blind. Because participants in both groups were performing neuromuscular exercises, as well as being unaware of the other group and the application of the protocol in the other group, they assumed that the main protocol was being applied to them. Also, the examiner was not aware of the existence of different interventions and which group each participant was in
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research Ethics Committees of Bu Ali Sina University-Hamedan
Street address
Bu-Ali Sina University, Shahid Mostafa Ahmadi Roshan Street, Hamedan
City
hamedan
Province
Hamadan
Postal code
۳۸۶۹۵-۶۵۱۷۸
Approval date
2021-10-13, 1400/07/21
Ethics committee reference number
IR.BASU.REC.1400.037
Health conditions studied
1
Description of health condition studied
Chronic ankle instability
ICD-10 code
M25.37
ICD-10 code description
Other instability, ankle and foot
Primary outcomes
1
Description
Variables derived from floor pressure system data (pressure foot) - static balance - dynamic balance - Properioception
Timepoint
Pre test_ Post test
Method of measurement
Plantar pressure system data (pressure foot)_ Biodex balance system_ Electrogoniometer
Secondary outcomes
1
Description
Quality of Life Questionnaire
Timepoint
Anxiety and Depression Questionnaire
Method of measurement
Questionnaire
Intervention groups
1
Description
Intervention group: Intervention group: Neuromuscular rehabilitation protocol was performed for 8 weeks 3 sessions per week for 30 minutes in each session. This training program, this exercises include One -legged knee flexion on three surfaces: flat, uneven surface and on balance boardToe stand with the help of the hand and without the help of the handOne-legged stand on three flat surfaces, uneven surface with eyes closed and on balance boardRunner’s pose on three flat surfaces, uneven surface with eyes closed and on balance boardCross-legged sway with the help of the hand, without the help of the hand, without the help of the hand with the eyes closed and on balance board and Toe walk
Category
Rehabilitation
2
Description
Intervention group: The neurofeedback training was performed using an 8-channel ProComp Infiniti device (ProComp Infiniti Procomp2 thought technology co ltd. Canada) and the Biograpth infiniti version 5.0 software. Prior to training protocol, the neurofeedback specialist gave the patients a complete explanation of the components of the neurofeedback device and all the components that make this treatment method more effective. Prior to each training session, noise-causing devices or artifacts such as rings, belts, cell phones and bank cards were placed away from the training area. The treatment protocol of the present study was performed for 8 weeks, 3 sessions per week and each session for 30 minutes . The patient would sit comfortably on a chair to perform the training protocol. Neurofeedback specialist identified 10-20 O1 and O2 points based on the international system, then the area and earlobe were cleansed with medical alcohol and Nuprep exfoliating gel (Nuprep, Weaver, USA). Then, the active electrode on the O1 region and the reference electrode on the O2 region were glued by Ten20 conductive paste (Weaver, USA) and the ground electrode was placed on the right ear .
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Bu-Ali Sina University
Full name of responsible person
Ali Yalfani
Street address
Shahid Mostafa Ahmadi Roshan Street,
City
hamedan
Province
Hamadan
Postal code
۳۸۶۹۵-۶۵۱۷۸
Phone
+98 81 3838 1601
Fax
+98 81 3838 1601
Email
ali_yalfani@yahoo.com
Web page address
https://www1.basu.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Bu Ali Sina university ethics committee in research
Full name of responsible person
Gholamhosein Majzobi
Street address
Vice Chancellery For Research Affairs, Bu Ali Sina University, Chahar Bagh Martyr Mustafa Ahmadi Roshan
City
Hamedan
Province
Hamadan
Postal code
۳۸۶۹۵-۶۵۱۷۸
Phone
+98 21 3838 1601
Fax
+98 21 3838 1601
Email
sakhai@basu.ac.ir
Web page address
https://basu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Bu Ali Sina university ethics committee in research
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
Bu Ali Sina University
Full name of responsible person
Ali Yalfani
Position
professor
Latest degree
Ph.D.
Other areas of specialty/work
Rehabilitation management
Street address
Bu-Ali Sina University, Shahid Mostafa Ahmadi Roshan Street
City
Hamedan
Province
Hamadan
Postal code
۳۸۶۹۵-۶۵۱۷۸
Phone
0098 81 8265636
Fax
+98 81 3838 1422
Email
ali_yalfani@yahoo.com
Web page address
https://res.basu.ac.ir/
Person responsible for scientific inquiries
Contact
Name of organization / entity
Bu Ali Sina University of Hamadan
Full name of responsible person
Ali Yalfani
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Rehabilitation management
Street address
Bu Ali Sina University, Chahar Bagh of martyr Mustafa Ahmadi Roshan, Iran
City
Hamedan
Province
Hamadan
Postal code
۳۸۶۹۵-۶۵۱۷۸
Phone
0098 81 8265636
Email
ali_yalfani@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Bu Ali Sina University of Hamadan
Full name of responsible person
Masoud Azizian
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Sport Medicine
Street address
Bu Ali Sina University, Chahar Bagh of martyr Mustafa Ahmadi Roshan, Iran
City
Hamedan
Province
Hamadan
Postal code
۳۸۶۹۵-۶۵۱۷۸
Phone
0098 81 8265636
Fax
+98 81 3825 0240
Email
m.azizian@phe.basu.ac.ir
Web page address
https://res.basu.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
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Not applicable
Title and more details about the data/document
Data files measured by testers will be shared after the study if needed.
When the data will become available and for how long
Start the course one year after the publication of results and articles
To whom data/document is available
Researchers and researchers whose field of work is similar to the present research and are employed in universities
Under which criteria data/document could be used
The data of the present study will be provided to other researchers only for comparison with future studies and the use of data and their analysis is not allowed.