The Effect of Close Kinetic Chain Exercises Following Seven Consecutive Sessions of Non-Invasive Brain Stimulation (tDCS vs. tPCS) on Pain, Balance, Movement Function of Women Affected by Knee Osteoarthritis.
Determining the effects of closed motor chain exercises following 7 consecutive sessions of non-invasive brain stimulation (tDCS versus tPCS) on pain, balance and motor performance of women with knee osteoarthritis in Kermanshah.
Design
Based on G.Power software version 3.1 with error level (α) of 0.05 for statistical tests of two domains, statistical power (β-1) of 0.80 and effect size reported by studies for effectiveness. Exercise therapy and education have been reported from 0.3 to 0.6 for pain and function
Settings and conduct
The participants underwent one of the transcranial stimulations of tDCS, tPCS or sham for 7 consecutive days and after finishing the stimulations, for one month, during 12 sessions (3 sessions per week), under strengthening exercises.
Participants/Inclusion and exclusion criteria
Entry criteria
Age 40 to 70 years, not using intra-articular injections in the last 3 months.
chronic knee pain most days,
Reduction of joint space
Entry ban criteria
Uncontrolled diabetes.
excessive obesity
Physiotherapy or knee surgery (within the last 12 months).
Lower limb arthroplasty.
Intra-articular steroid injections (within the last 6 months).
Systemic arthritic disease.
Additional orthopedic injuries: joint dysplasia
Neuromuscular diseases (MS and Parkinson's)
Fracture and surgery in the lower limb.
Intervention groups
Group 1: 12 sessions of closed motor chain exercises followed by seven consecutive sessions of itDCS stimulation
Group 2: 12 sessions of closed motor chain exercises followed by seven consecutive sessions of itPCS stimulation
Group 3: 12 sessions of closed motor chain exercises followed by seven consecutive sessions of sham stimulation
Main outcome variables
Pain intensity and perceived fatigue
Physical performance indicators
Knee instability
sense of depth
Static balance and postural oscillations
Strength and electrical activity of quadriceps muscles
General information
Reason for update
Acronym
KKOAK
IRCT registration information
IRCT registration number:IRCT20240911063011N1
Registration date:2025-03-18, 1403/12/28
Registration timing:registered_while_recruiting
Last update:2025-03-18, 1403/12/28
Update count:0
Registration date
2025-03-18, 1403/12/28
Registrant information
Name
Niloofar Afrasiaby
Name of organization / entity
The University of razi Kermanshah
Country
Iran (Islamic Republic of)
Phone
+98 990 972 5642
Email address
n.afrasiby9974@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2025-01-20, 1403/11/01
Expected recruitment end date
2025-05-21, 1404/02/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effect of Close Kinetic Chain Exercises Following Seven Consecutive Sessions of Non-Invasive Brain Stimulation (tDCS vs. tPCS) on Pain, Balance, Movement Function of Women Affected by Knee Osteoarthritis.
Public title
The Effect of Close Kinetic Chain Exercises Following Seven Consecutive Sessions of Non-Invasive Brain Stimulation (tDCS vs. tPCS) on Pain, Balance, Movement Function of Women Affected by Knee Osteoarthritis in Kermanshah Province.
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
• Having the clinical criteria of knee osteoarthritis of the American College of Rheumatology. (Altamn et al., 1991)
• Having II score ≤ in the Kellgren and Lawrence criteria.
• Not using intra-articular injections during the last 3 months.
• Chronic knee pain most days, for at least 3 months, pain score of at least 4 on the visual analogue pain scale.
• Reduction of joint space or osteophyte in radiography.
Exclusion criteria:
• Uncontrolled diabetes.
• Body mass index greater than or equal to (BMI>40kg/m2), patients with extreme obesity.
• Physiotherapy or knee surgery (within the last 12 months).
• Lower limb arthroplasty.
• Intra-articular steroid injections (during the last 6 months).
• Systemic arthritic disease.
• Additional orthopedic injuries in the lower limb (such as joint dysplasia).
• Neuromuscular disorders that interfere with daily functioning such as (stroke, uncontrolled muscle stiffness, tumor,...) patients who are unable to walk without assistive devices.
• Patients who have undergone other exercise or nutritional treatments in the last three months.
• Neuromuscular diseases (such as MS and Parkinson's) that interfere with the training program.
• Fracture and surgery in the lower limb.
• Use of any other therapeutic intervention during the period that the subjects are in the study.
Age
From 40 years old to 70 years old
Gender
Female
Phase
N/A
Groups that have been masked
Participant
Sample size
Target sample size:
45
Randomization (investigator's opinion)
Randomized
Randomization description
Statistical sample based on G.Power software version 3.1 with error level (α) of 0.05 for statistical tests of two domains, statistical power (β-1) of 0.80 and effect size reported by Studies for the effectiveness of exercise therapy and training have reported from 0.3 to 0.6 for pain and function[76], where 0.5 was considered as the effect size. Therefore, the number of selected samples for the statistical test of covariance, where the pre-tests are considered as covariance variables, was estimated to be 42 people, which was determined by considering the attrition of 45 people. Subjects were randomized by Random Allocation software into groups: 12 sessions of closed motor chain exercises followed by seven consecutive sessions of non-invasive brain stimulation (tDCS), 12 sessions of closed motor chain exercises followed by seven consecutive sessions of non-invasive brain stimulation (tDCS). tPCS) and 12 sessions of closed motor chain exercises will be assigned following seven sessions of consecutive non-invasive brain stimulation (sham).
Blinding (investigator's opinion)
Double blinded
Blinding description
The arrangements considered for this study are two-way blind. So that by applying non-invasive stimulations by a person not involved in the research, the evaluator will not have any knowledge about the type of electrical stimulation intervention assigned to the groups, and the subjects will not know about the differences applied in the type of stimulation of the groups. parallels will be unaware, so that they will receive the stimulation in the first 30 seconds and will be gradually cut off; Also, it will be possible to keep the person who will analyze the data about the groups and exercises assigned to them.
Kermanshah Elahiye Resalat 20th nahalestan Alely 16 Number 14
City
Kermanshah
Province
Kermanshah
Postal code
6719413331
Phone
+98 990 972 5642
Fax
Email
n.afrasiaby9974@gmail.com
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
Yes - There is a plan to make this available
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
Yes - There is a plan to make this available
Title and more details about the data/document
Studying the effects of closed motor chain exercises following seven consecutive sessions of non-invasive brain stimulation (tDCS versus tPCS) on pain, balance and motor function of women with knee osteoarthritis in Kermanshah.
When the data will become available and for how long
6 months after the results are published
To whom data/document is available
Masters and PhD students in corrective movements
Under which criteria data/document could be used
In order to be used in the field of rehabilitation and its promotion
From where data/document is obtainable
Razi University of Kermanshah - Faculty of Sports Sciences, Dr. Farzaneh Gandami
What processes are involved for a request to access data/document