The Effect of Transcranial Direct Current Stimulation with Postural Training on Static and Dynamic Balance During Single and Dual Cognitive Tasks in Patients with Chronic Ankle Instability
The Effect of Transcranial Direct Current Stimulation with Postural Training on Static and Dynamic Balance During Single and Dual Cognitive Tasks in Patients with Chronic Ankle Instability
Design
A controlled, double-blind, single-center, randomized clinical trial with 40 participants in 2 groups of 20.
Settings and conduct
In the Neuromuscular Rehabilitation Research Center patients will conduct the therapeutic intervention for 4 weeks, 3 sessions per week, in 2 groups; the first group will receive tDCS electrical stimulation along with postural exercises. The second group will receive sham-tDCS stimulation along with postural exercises.
Participants/Inclusion and exclusion criteria
Inclusion Criteria: Age between 18 and 30 years؛ History of ankle sprain more than one year ago؛ Report of at least 2 repetitions of the patient's perception of ankle instability or giving way in the past six months that affects the person's daily activities؛ Score below 24 on the CAIT (Cumberland Ankle Instability Tool) questionnaire. Exclusion Criteria: Report of any neurological disease that affects the patient's movement control (multiple sclerosis, history of stroke, Parkinson's, neuropathy)؛Received tDCS interventions in the last three months؛ Attendance at a rehabilitation program other than the current study؛ Score above 24 on the CAIT questionnaire
Intervention groups
Intervention group 1: In this group, according to the protocol, patients receive postural exercises on the device for 20 minutes simultaneously with tDCS stimulation in the M1 area of the cerebral cortex. Intervention group 2: In this group, according to the protocol, patients receive postural exercises on the device for 20 minutes simultaneously with Sham-tDCS stimulation in the M1 area of the cerebral cortex.
Main outcome variables
Anterior-posterior stability index; Overall stability index; Mediolateral stability index
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20250606066090N1
Registration date:2025-06-08, 1404/03/18
Registration timing:prospective
Last update:2025-06-08, 1404/03/18
Update count:0
Registration date
2025-06-08, 1404/03/18
Registrant information
Name
Mohammad Rasool Mallaki
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 23 3365 4180
Email address
rasoolmallaki@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2025-06-22, 1404/04/01
Expected recruitment end date
2025-09-23, 1404/07/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effect of Transcranial Direct Current Stimulation with Postural Training on Static and Dynamic Balance During Single and Dual Cognitive Tasks in Patients with Chronic Ankle Instability
Public title
The Effect of Transcranial Direct Current Stimulation with Postural Training on Static and Dynamic Balance During Single and Dual Cognitive Tasks in Patients with Chronic Ankle Instability
Purpose
Health service research
Inclusion/Exclusion criteria
Inclusion criteria:
Age between 18 and 30 years
History of ankle sprain that has been more than one year
Report of at least 2 repetitions of the patient's perception of ankle instability or giving way in the past six months that affects the person's daily activities
Score below 24 on the CAIT (Cumberland Ankle Instability Tool) questionnaire
Exclusion criteria:
Report of any neurological disease that affects the patient's movement control (multiple sclerosis, history of stroke, Parkinson's, neuropathy)
Receiving tDCS interventions in the last three months
Attending a rehabilitation program other than the current study
Score above 24 on the CAIT questionnaire
Age
From 18 years old to 30 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Investigator
Data analyser
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
40 participants will be randomly divided into 2 groups (Group 1 or 2) through random selection of fully sealed, coded envelopes.
Blinding (investigator's opinion)
Double blinded
Blinding description
In this study, one group receives postural exercises with tDCS, and the other group receives postural exercises with sham tDCS stimulation. The study is double-blinded, so that the participants are unaware of the grouping and intervention of the other group; in addition, the therapist and the evaluator, who are separate from each other, are also unaware of the group of participants.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Semnan University of Medical Sciences
Street address
Semnan University of Medical Sciences, Basij Blvd, Semnan
City
Semnan
Province
Semnan
Postal code
3514799442
Approval date
2025-05-19, 1404/02/29
Ethics committee reference number
IR.SEMUMS.REC.1403.135
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
Anterior-posterior stability index
Timepoint
Before the intervention, after the intervention and one month after the intervention
Method of measurement
Biodex device (made in the USA)
2
Description
Overall Stability Index
Timepoint
Before the intervention, after the intervention and one month after the intervention
Method of measurement
Biodex device (made in the USA)
3
Description
Mediolateral Stability Index
Timepoint
Before the intervention, after the intervention and one month after the intervention
Method of measurement
Biodex device (made in the USA)
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: In this group, according to the protocol, patients receive postural exercises on the device for 20 minutes simultaneously with tDCS stimulation in the M1 region of the cerebral cortex.
Category
Rehabilitation
2
Description
Intervention group: In this group, according to the protocol, patients receive postural exercises on the device for 20 minutes simultaneously with Sham-tDCS stimulation in the M1 region of the cerebral cortex.
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Neuromuscular Rehabilitation Research Center
Full name of responsible person
Fatemeh Ehsani
Street address
Neuromuscular Rehabilitation Research Center, Qods Blvd, Mashahir Aven.
City
Semnan
Province
Semnan
Postal code
3513138111
Phone
+98 23 3365 4180
Email
fatemehehsani59@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Abasali Vafaie
Street address
Semnan University of Medical Sciences, Basij Blvd, Semnan.
City
Semnan
Province
Semnan
Postal code
3514799442
Phone
+98 23 3345 1336
Email
sem.ums.res@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Semnan 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
Semnan University of Medical Sciences
Full name of responsible person
Fatemeh Ehsani
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
Neuromuscular Rehabilitation Research Center, Qods Blvd, Mashahir Aven.
City
Semnan
Province
Semnan
Postal code
3513138111
Phone
+98 23 3365 4180
Email
fatemehehsani59@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Fatemeh Ehsani
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
Neuromuscular Rehabilitation Research Center, Qods Blvd, Mashahir Aven.
City
Semnan
Province
Semnan
Postal code
3513138111
Phone
+98 23 3365 4180
Email
fatemehehsani59@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Mohammad Rasool Mallaki
Position
MSc Student
Latest degree
Bachelor
Other areas of specialty/work
Physiotherapy
Street address
Neuromuscular Rehabilitation Research Center, Qods Blvd, Mashahir Aven.
City
Semnan
Province
Semnan
Postal code
3513138111
Phone
+98 23 3365 4180
Email
rasoolmallaki@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