Investigating the adding effects of anodal transcranial direct current stimulation to balance training on balance and functional performance of athletes with chronic ankle instability.
Investigating the adding effects of anodal transcranial direct current stimulation to balance training on balance and functional performance of athletes with chronic ankle instability.
Design
Randomized Clinical trial with stratified randomization,Including two parallel interventional groups,Double blind
Settings and conduct
Both groups of patients will receive their treatment in Chamran Hospital. In the first group, balance exercises with anodal tDCS will be given to the patients, and in the second group, balance exercises with sham tDCS will be given to the patients. The patients and the evaluator will be blinded in the study.
Participants/Inclusion and exclusion criteria
Inclusion criteria: History of at least one significant ankle sprain that has been more than 3 months since the last sprain. History of emptying and twisting again and feeling of instability in the injured ankle (he/she must have feel emptying his/her ankle at least two times in the past 6 montgs).Recreational athletes engaged in volleyball and basketball, who regularly perform the desired sports activity for at least 6 months, 3 times a week and 2 hours a day. CAIT score equal to or less than 25؛ Daily activity scale equal to or less than 90% according to FAAM questionnaire؛ Exercise activity scale equal to or less than 80% according to FAAM questionnaire; Exclusion criteria: surgery or fracture or acute damage of musculoskeletal structures in any of the lower limbs during the last 3 months .History of neurological disease. Mental and cognitive problems (Mini-Mental Status Exam Score ≤23).Taking drugs affecting the CNS in the last 6 months. Drug and alcohol.
Intervention groups
Two intervention groups, which include the group of balance exercises with anodal tDCS and the group of balance exercises with sham tDCS.
Investigating the adding effects of anodal transcranial direct current stimulation to balance training on balance and functional performance of athletes with chronic ankle instability.
Public title
Investigating the adding effects of anodal transcranial direct current stimulation to balance training on balance and functional performance of athletes with chronic ankle instability.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Inclusion criteria: History of at least one significant ankle sprain that has been more than 3 months since the last sprain and was accompanied by pain and swelling and prevented the person from doing the desired work for at least one day. History of emptying and twisting again and feeling of instability in the injured ankle (he/she must have feel emptying his/her ankle at least two times in the past 6 months).Recreational athletes engaged in volleyball and basketball, who regularly perform the desired sports activity for at least 6 months, 3 times a week and 2 hours a day. CAIT score equal to or less than 25؛ Daily activity scale equal to or less than 90% according to FAAM questionnaire؛ Exercise activity scale equal to or less than 80% according to FAAM questionnaire.
Exclusion criteria:
Exclusion criteria: History of surgery of musculoskeletal structures (such as bones, joints, nerves) in any of the lower limbs. History of lower limb fracture. Acute damage to other musculoskeletal structures of the lower limb joints during the last 3 months that affects the function and stability of the joint (such as fractures, sprains) and prevents the person from performing his/her desired physical activities for at least one day. History of neurological disease, visual, vestibular or any other complications. Mental and cognitive problems (Mini-Mental Status Exam Score ≤23). Being hospitalized for the past year due to mental illness. History of head surgery, brain tumor or metal implant in the head. Taking drugs that affect the central nervous system such as dextromethorphan and D-cycloserine in the last 6 months. Drug and alcohol abuse.
Age
From 18 years old to 40 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
36
Randomization (investigator's opinion)
Randomized
Randomization description
The randomization method used was permutation block method. (considering blocks of four with the number of 9 blocks)
Blinding (investigator's opinion)
Double blinded
Blinding description
A physiotherapist applies the interventions and another physiotherapist colleague, who is unaware of the patient grouping, performs the evaluations. Also, the participants of the two groups will be treated in a separate place where they will not have any contact with each other.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Shiraz Rehabilitation Faculty Ethics Committee
Street address
Faculty of Rehabilitation Sciences, Shahid Doran Campus, Behind Amir al-Momenin (AS) Burn Accident Hospital, Sadra Blvd, Shiraz Town
City
Shiraz
Province
Fars
Postal code
71987-54361
Approval date
2024-01-24, 1402/11/04
Ethics committee reference number
IR.SUMS.REHAB.REC.1402.021
Health conditions studied
1
Description of health condition studied
Chronic Ankle Instability
ICD-10 code
S93.4
ICD-10 code description
Sprain of Ankle
Primary outcomes
1
Description
Dynamic balance
Timepoint
Initiation of treatment, immediately after and one month after the end of the intervention
Method of measurement
Modified star excursion balance test(mSEBT)
2
Description
Functional performance
Timepoint
Initiation of treatment, immediately after and one month after the end of the intervention
Method of measurement
Agility t-test
3
Description
Functional performance
Timepoint
Initiation of treatment, immediately after and one month after the end of the intervention
Method of measurement
Triple hop test
4
Description
Patient reported performance
Timepoint
Initiation of treatment, immediately after and one month after the end of the intervention
Method of measurement
FAAM questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: group of balance exercises with anodal tDCS: patients in this experimental group receive balance exercises with anodal tDCS for 4 weeks at intervals of one day.
Category
Rehabilitation
2
Description
Control group: group of balance training with Sham tDCS: patients in this group receive balance exercises with Sham tDCS for 4 weeks at intervals of one day.
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Chamran hospital
Full name of responsible person
Sara Abolahari Shirazi
Street address
Chamran Hospital, Chamran Blvd, Shiraz Town
City
Shiraz
Province
Fars
Postal code
15644-71948
Phone
+98 71 3624 0101
Email
SAhrari@Sums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Dr. Mohammad Hashem Hashempour
Street address
7th floor, Central building of Shiraz University of Medical Sciences, next to Red Crescent, Zand St, Shiraz Town
City
Shiraz
Province
Fars
Postal code
71348-14336
Phone
+98 71 3235 7282
Email
hashempurm@sums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shiraz University of Medical Sciences
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
Shiraz University of Medical Sciences
Full name of responsible person
Sara Abolahari Shirazi
Position
Assistant Professor of Shiraz University of Medical Sciences
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
Faculty of Rehabilitation Sciences, Shahid Doran Campus, Behind Amir al-Momenin (AS) Burn Accident Hospital, Sadra Blvd, Shiraz Town
City
Shiraz
Province
Fars
Postal code
71987-54361
Phone
+98 71 3212 2600
Email
SAhrari@Sums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Sara Abolahari Shirazi
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
Faculty of Rehabilitation Sciences, Shahid Doran Campus, Behind Amir al-Momenin (AS) Burn Accident Hospital, Sadra Blvd, Shiraz Town
City
Shiraz
Province
Fars
Postal code
71987-54361
Phone
+98 71 3212 2600
Email
SAhrari@Sums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Amir Javanray
Position
Masters student
Latest degree
Bachelor
Other areas of specialty/work
Physiotherapy
Street address
Faculty of Rehabilitation Sciences, Shahid Doran Campus, Behind Amir al-Momenin (AS) Burn Accident Hospital, Sadra Blvd, Shiraz Town
City
Shiraz
Province
Fars
Postal code
71987-54361
Phone
+98 71 3212 2600
Email
amirjavanray.1997@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available