Protocol summary

Study aim
Evaluation of the effect of tDCS on static postural balance in subjects with KOA during static standing
Design
This study is a Double-blind, crossover, randomized, sham-controlled clinical trial. This experiment explores the effect of tDCS on static postural balance parameters in people with mild to moderate KOA. Static postural balance parameters will be assessed while standing barefoot on a force plate under open and closed eye conditions.
Settings and conduct
This study is a Double-blind, crossover, randomized, sham-controlled clinical trial that will be conducted in the Musculoskeletal Research Center at Isfahan University of Medical Sciences. The participants will be masked to the stimulation condition. A researcher (assessor), unaware of the stimulation conditions (real and sham), will assess static balance in two conditions of open and closed eye, before and after the interventions (real and sham).
Participants/Inclusion and exclusion criteria
Inclusion Criteria: Age of 45–70 years, Radiological signs of mild to moderate knee osteoarthritis according to K-L scale, Pain and tenderness in medial side of knee joint (VAS > 3), Walking without use of assistive devices Exclusion Criteria: Any neurological disorders that would influence balance, Taken medication that affects balance control, Previous knee injury or surgery, Fracture of either lower extremity within 6 months, Any congenital or acquired musculoskeletal disorder in lower extremity, Presence of any inflammatory arthritis, Any contraindication to apply tDCS such as head implants, history of epilepsy/seizure or brain tumors, and pregnancy
Intervention groups
Each participant will be exposed counterbalanced randomly to two experimental conditions, including real tDCS and sham tDCS with a one-week washout period.
Main outcome variables
Static Balance

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20160423027554N3
Registration date: 2023-03-25, 1402/01/05
Registration timing: prospective

Last update: 2023-03-25, 1402/01/05
Update count: 0
Registration date
2023-03-25, 1402/01/05
Registrant information
Name
Zohreh Shafizadegan
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 3792 5007
Email address
zanbagh625@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-05-22, 1402/03/01
Expected recruitment end date
2023-11-22, 1402/09/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effects of transcranial direct current stimulation on static balance in people with knee osteoarthritis
Public title
The effects of transcranial direct current stimulation on static balance in people with knee osteoarthritis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age of 45–70 years Radiological signs of mild to moderate knee osteoarthritis according to K-L scale Pain and tenderness in medial side of knee joint (VAS > 3) Walking without use of assistive devices
Exclusion criteria:
Obesity with body mass index (BMI) >30 kg/m2 Any neurological disorders that would influence balance Taken medication that affects balance control Previous knee injury or surgery / prior arthroplasty of any joint of lower extremity Fracture of either lower extremity within 6 months Any congenital or acquired musculoskeletal disorder in lower extremity Presence of any inflammatory arthritis Any contraindication to apply tDCS such as head implants, history of epilepsy/seizure or brain tumors, and pregnancy
Age
From 45 years old to 70 years old
Gender
Both
Phase
N/A
Groups that have been masked
  • Participant
  • Outcome assessor
Sample size
Target sample size: 26
Randomization (investigator's opinion)
Randomized
Randomization description
This study does not have a control group. All participants will be exposed counterbalanced randomly to two experimental conditions, including real tDCS and sham tDCS with a one-week washout period. All participants will be randomly assigned (1:1), using a web-based randomisation system (http://www.randomization.com), to receive real and sham tDCS, based on the block randomization method, in which the block size is 2 and the number of blocks is 13. The researcher who assigns the volunteers to groups based on the random list is different from the researcher who performs the treatment.
Blinding (investigator's opinion)
Double blinded
Blinding description
The participants will be masked to the stimulation condition. A researcher (assessor), unaware of the stimulation conditions (real and sham), will assess static balance in two conditions of open and closed eye, before and after the interventions (real and sham).
Placebo
Used
Assignment
Crossover
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Research ethics Committees of Isfahan University of Medical Sciences and Health Services
Street address
Hezar Jarib Street, Isfahan University of Medical Sciences, Isfahn.
City
Isfahan
Province
Isfehan
Postal code
81746-73461
Approval date
2023-02-21, 1401/12/02
Ethics committee reference number
IR.MUI.REC.1401.055

Health conditions studied

1

Description of health condition studied
Knee Osteoarthritis
ICD-10 code
M17
ICD-10 code description
Osteoarthritis of knee

Primary outcomes

1

Description
Static Balance
Timepoint
Before and after the intervention
Method of measurement
Measurement of static balance parameters using the force plate

Secondary outcomes

1

Description
Strength of the quadriceps and hamstring muscles
Timepoint
Before and after the intervention
Method of measurement
Dynamometer

2

Description
Pain intensity
Timepoint
Before and after the intervention
Method of measurement
Visual Analog Scale (VAS)

Intervention groups

1

Description
Intervention group: real tDCS: َAll participants will be received real and sham tDCS with a counterbalanced crossover design within a one-week interval. The electrode montages for the sham and real tDCS conditions are identical. The anode electrode will be place on the vertex (Cz based on the 10-20 system) and the return electrode will be fixed centrally over the supraorbital area. The intensity and duration of real tDCS will be 2 mA and 20 minutes, respectively. This study does not have a control group.
Category
Rehabilitation

2

Description
Intervention group: sham-tDCS: َAll participants will be received real and sham tDCS with a counterbalanced crossover design within a one-week interval. The electrode montages for the sham and real tDCS conditions are identical. The anode electrode will be place on the vertex (Cz based on the 10-20 system) and the return electrode will be fixed centrally over the supraorbital area. For sham-tDCS, stimulation will be conducted for 30 seconds, and then the stimulator will be turned off without the participant’s awareness. This study does not have a control group.
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Musculoskeletal Research Center of Faculty of Rehabilitation Sciences at Isfahan University of Medic
Full name of responsible person
Dr. Zohreh Shafizadegan
Street address
Hazar Jarib Street, Isfahan University of Medical Sciences, Isfahan, ran
City
Isfahan
Province
Isfehan
Postal code
81746-73461
Phone
+98 31 3792 5007
Email
z.shafizadegan@rehab.mui.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Dr GholamReza Asqari
Street address
Hazar Jarib Street, Isfahan University of Medical Sciences, Isfahan, Iran
City
Isfahan
Province
Isfehan
Postal code
81746-73461
Phone
+98 31 3792 3060
Email
research@mui.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Esfahan 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
Esfahan University of Medical Sciences
Full name of responsible person
Dr Zohreh Shafizadegan
Position
Lecturer, Musculoskeletal Research Center, Department of Physical Therapy, Isfahan University of Med
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
Hazar Jarib Street, Isfahan University of Medical Sciences, Isfahan, Iran
City
Isfahan
Province
Isfehan
Postal code
81746-73461
Phone
+98 31 3792 5007
Email
z.shafizadegan@rehab.mui.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Dr Zohreh Shafizadegan
Position
Lecturer, Musculoskeletal Research Center, Department of Physical Therapy, Isfahan University of Med
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
Hazar Jarib Street, Isfahan University of Medical Sciences, Isfahan, Iran
City
Isfahan
Province
Isfehan
Postal code
81746-73461
Phone
+98 31 3792 5007
Email
z.shafizadegan@rehab.mui.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Dr Zohreh Shafizadegan
Position
Lecturer, Musculoskeletal Research Center, Department of Physical Therapy, Isfahan University of Med
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
Hazar Jarib Street, Isfahan University of Medical Sciences, Isfahan, Iran
City
Isfahan
Province
Isfehan
Postal code
81746-73461
Phone
+98 31 3792 5007
Email
z.shafizadegan@rehab.mui.ac.ir

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
Not applicable
Data Dictionary
Not applicable
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