Back to resultsThe Effect of Graded Motor Imagery on Pain and Function in Individuals With Knee Osteoarthritis
Primary Purpose
Knee Osteoarthritis, Limitation, Mobility
Status
Recruiting
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Graded Motor Imagery (GMI)
Transcutaneous Electrical Nerve Stimulation (TENS)
Conventional Physiotherapy Program
Home Exercise Protocol
Sponsored by
About this trial
This is an interventional treatment trial for Knee Osteoarthritis focused on measuring Pain, Knee Joint, Exercise, Range of Motion, Muscle Strength
Eligibility Criteria
Inclusion Criteria: Minimum score of 24 on the Mini Mental State Examination (indicating no mild or severe dementia) Diagnosis of moderate unilateral knee osteoarthritis persisting for more than 12 months according to American College of Rheumatology (ACR) criteria Experience of pain with a severity rating of 3 or higher on the Visual Analog Scale (VAS) for activities such as stair climbing, sitting, and squatting, lasting for at least 6 months (moderate to severe pain) Age between 45 and 64 years Residing in the city where the study is conducted Ability to walk independently Presence of limitations in knee range of motion (ROM) Symptomatic and radiographically confirmed OA diagnosis of Kellgren and Lawrence grade I-III Exclusion Criteria: Patients who are unwilling to participate in the study Patients presenting with secondary OA due to conditions such as rheumatoid arthritis, gout, septic arthritis, tuberculosis, tumor, trauma, hemophilia, major medical or psychiatric disorders, recent fractures, presence of effusion or open reduction and internal fixation in the knee Presence of a neuromuscular disease History of intra-articular injections in the past 6 months Patients undergoing medication changes Presence of any chronic illness that would hinder participation in the treatment program Participation in a physiotherapy program for OA in the last 12 weeks Movement limitations or limb deficiency in the contralateral lower extremity Presence of visual or hearing problems that would affect treatment adherence.
Sites / Locations
- Artvin State HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Graded Motor Imagery
Transcutaneous Electrical Nerve Stimulation (TENS)
Arm Description
Each patient in the Graded Motor Imagery group will receive a treatment protocol consisting of Graded Motor Imagery, conventional physiotherapy, and home exercises.
Each patient in the Transcutaneous Electrical Nerve Stimulation group will receive a treatment protocol consisting of Transcutaneous Electrical Nerve Stimulation, conventional physiotherapy, and home exercises.
Outcomes
Primary Outcome Measures
Pain Intensity
Visual Analogue Scale (VAS) will be used to evaluate the severity of pain felt around the knee joint. Participants will be asked to mark the severity of the pain they feel (rest, activity and night) on a 10 cm horizontal line, from 0 (no pain) to 10 (unbearable pain).
Pain Intensity
Visual Analogue Scale (VAS) will be used to evaluate the severity of pain felt around the knee joint. Participants will be asked to mark the severity of the pain they feel (rest, activity and night) on a 10 cm horizontal line, from 0 (no pain) to 10 (unbearable pain).
Pain Intensity
Visual Analogue Scale (VAS) will be used to evaluate the severity of pain felt around the knee joint. Participants will be asked to mark the severity of the pain they feel (rest, activity and night) on a 10 cm horizontal line, from 0 (no pain) to 10 (unbearable pain).
Pain Pressure Threshold
The pain pressure threshold will be measured using a algometer. The pain pressure threshold will be evaluated at two points while the patient is lying in a lateral position: 1. point located 2 cm below the medial edge of the patella, and 2. point located 2 cm below the lateral edge of the patella. The evaluator will position the algometer perpendicular to each point and apply gradual pressure at a constant rate of approximately 0.5 kg/cm2/s. The pressure will be increased until the participant reports feeling pain. Each point considered for analysis will be assessed three times, and the average value will be recorded.
Pain Pressure Threshold
The pain pressure threshold will be measured using a algometer. The pain pressure threshold will be evaluated at two points while the patient is lying in a lateral position: 1. point located 2 cm below the medial edge of the patella, and 2. point located 2 cm below the lateral edge of the patella. The evaluator will position the algometer perpendicular to each point and apply gradual pressure at a constant rate of approximately 0.5 kg/cm2/s. The pressure will be increased until the participant reports feeling pain. Each point considered for analysis will be assessed three times, and the average value will be recorded.
Pain Pressure Threshold
The pain pressure threshold will be measured using a algometer. The pain pressure threshold will be evaluated at two points while the patient is lying in a lateral position: 1. point located 2 cm below the medial edge of the patella, and 2. point located 2 cm below the lateral edge of the patella. The evaluator will position the algometer perpendicular to each point and apply gradual pressure at a constant rate of approximately 0.5 kg/cm2/s. The pressure will be increased until the participant reports feeling pain. Each point considered for analysis will be assessed three times, and the average value will be recorded.
WOMAC Pain Subscale
The subscale can take a score between 0-20 and evaluates pain during walking on flat ground, going up and down stairs, standing, sitting and lying down.
WOMAC Pain Subscale
The subscale can take a score between 0-20 and evaluates pain during walking on flat ground, going up and down stairs, standing, sitting and lying down.
WOMAC Pain Subscale
The subscale can take a score between 0-20 and evaluates pain during walking on flat ground, going up and down stairs, standing, sitting and lying down.
Secondary Outcome Measures
Western Ontario and McMaster University Osteoarthritis Index (WOMAC)
The WOMAC index will be used to evaluate pain, stiffness, and function. It contains 24 items scored from 0 to 4: 0=absent, 1=mild, 2=moderate, 3=severe, and 4=extreme.
Western Ontario and McMaster University Osteoarthritis Index (WOMAC)
The WOMAC index will be used to evaluate pain, stiffness, and function. It contains 24 items scored from 0 to 4: 0=absent, 1=mild, 2=moderate, 3=severe, and 4=extreme.
Western Ontario and McMaster University Osteoarthritis Index (WOMAC)
The WOMAC index will be used to evaluate pain, stiffness, and function. It contains 24 items scored from 0 to 4: 0=absent, 1=mild, 2=moderate, 3=severe, and 4=extreme.
Range of Motion (ROM)
Knee ROM will be evaluated with a digital goniometer while the participants lie comfortably in the prone position while active knee joint motion will be evaluated. Evaluation will be performed with the pivot point following the lateral condyle of the femur, the fixed arm following the lateral midline of the femur, and the mobile arm following the fibula. The measurements will be repeated three times for the affected and unaffected side, and the best value between the measurements will be recorded.
Range of Motion (ROM)
Knee ROM will be evaluated with a digital goniometer while the participants lie comfortably in the prone position while active knee joint motion will be evaluated. Evaluation will be performed with the pivot point following the lateral condyle of the femur, the fixed arm following the lateral midline of the femur, and the mobile arm following the fibula. The measurements will be repeated three times for the affected and unaffected side, and the best value between the measurements will be recorded.
Range of Motion (ROM)
Knee ROM will be evaluated with a digital goniometer while the participants lie comfortably in the prone position while active knee joint motion will be evaluated. Evaluation will be performed with the pivot point following the lateral condyle of the femur, the fixed arm following the lateral midline of the femur, and the mobile arm following the fibula. The measurements will be repeated three times for the affected and unaffected side, and the best value between the measurements will be recorded.
Isometric Muscle Strength
Flexion and extension isometric muscle strength of the knee will be assessed using a hand-held dynamometer. During the assessment, maximum voluntary contraction will be requested. Measurements will be repeated three times (5 seconds of contraction followed by 30 seconds of rest) for both affected and unaffected knees, and the average value will be recorded in Newtons (N). Patients will sit with their backs straight, arms crossed, hips flexed at 90°, and knees flexed at 30°, with their feet hanging off the side of the bed. The dynamometer will be placed on the anterior surface of the tibia, two fingers above the lateral malleolus.
Isometric Muscle Strength
Flexion and extension isometric muscle strength of the knee will be assessed using a hand-held dynamometer. During the assessment, maximum voluntary contraction will be requested. Measurements will be repeated three times (5 seconds of contraction followed by 30 seconds of rest) for both affected and unaffected knees, and the average value will be recorded in Newtons (N). Patients will sit with their backs straight, arms crossed, hips flexed at 90°, and knees flexed at 30°, with their feet hanging off the side of the bed. The dynamometer will be placed on the anterior surface of the tibia, two fingers above the lateral malleolus.
Isometric Muscle Strength
Flexion and extension isometric muscle strength of the knee will be assessed using a hand-held dynamometer. During the assessment, maximum voluntary contraction will be requested. Measurements will be repeated three times (5 seconds of contraction followed by 30 seconds of rest) for both affected and unaffected knees, and the average value will be recorded in Newtons (N). Patients will sit with their backs straight, arms crossed, hips flexed at 90°, and knees flexed at 30°, with their feet hanging off the side of the bed. The dynamometer will be placed on the anterior surface of the tibia, two fingers above the lateral malleolus.
Mini Mental State Examination
The Mini-Mental State Examination (MMSE) will be used to assess the cognitive status of patients. It consists of 11 questions and is evaluated on a scale of 30 points. A score between 24-30 is considered normal, 18-23 indicates mild cognitive impairment, and a score of 17 or below is indicative of severe dementia. The MMSE assesses orientation, memory, attention, calculation, recall, language, motor function, perception, and visuospatial abilities.
Mini Mental State Examination
The Mini-Mental State Examination (MMSE) will be used to assess the cognitive status of patients. It consists of 11 questions and is evaluated on a scale of 30 points. A score between 24-30 is considered normal, 18-23 indicates mild cognitive impairment, and a score of 17 or below is indicative of severe dementia. The MMSE assesses orientation, memory, attention, calculation, recall, language, motor function, perception, and visuospatial abilities.
Mini Mental State Examination
The Mini-Mental State Examination (MMSE) will be used to assess the cognitive status of patients. It consists of 11 questions and is evaluated on a scale of 30 points. A score between 24-30 is considered normal, 18-23 indicates mild cognitive impairment, and a score of 17 or below is indicative of severe dementia. The MMSE assesses orientation, memory, attention, calculation, recall, language, motor function, perception, and visuospatial abilities.
Timed Get Up and Go Test (TUG)
The test will be initiated with each participant sitting on a chair with their back supported, arms resting on their lap, and both feet flat on the floor. Participants will be timed using a stopwatch as they rise from the chair (45 cm in height), walk 3 meters as quickly and safely as possible, turn around, return to the chair, and sit down. The time taken for each participant to complete these tasks will be recorded using a stopwatch.
Timed Get Up and Go Test (TUG)
The test will be initiated with each participant sitting on a chair with their back supported, arms resting on their lap, and both feet flat on the floor. Participants will be timed using a stopwatch as they rise from the chair (45 cm in height), walk 3 meters as quickly and safely as possible, turn around, return to the chair, and sit down. The time taken for each participant to complete these tasks will be recorded using a stopwatch.
Timed Get Up and Go Test (TUG)
The test will be initiated with each participant sitting on a chair with their back supported, arms resting on their lap, and both feet flat on the floor. Participants will be timed using a stopwatch as they rise from the chair (45 cm in height), walk 3 meters as quickly and safely as possible, turn around, return to the chair, and sit down. The time taken for each participant to complete these tasks will be recorded using a stopwatch.
Full Information
NCT ID
NCT05925517
First Posted
June 22, 2023
Last Updated
August 30, 2023
Sponsor
Artvin Coruh University
Collaborators
Marmara University
1. Study Identification
Unique Protocol Identification Number
NCT05925517
Brief Title
The Effect of Graded Motor Imagery on Pain and Function in Individuals With Knee Osteoarthritis
Official Title
The Effect of Graded Motor Imagery on Pain and Function in Individuals With Knee Osteoarthritis: A Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 15, 2023 (Actual)
Primary Completion Date
January 15, 2024 (Anticipated)
Study Completion Date
June 28, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Artvin Coruh University
Collaborators
Marmara University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The aim of this study is to investigate whether Graded Motor Imagery (GMI) application is as effective as Transcutaneous Electrical Nerve Stimulation (TENS) in individuals with knee osteoarthritis (OA). The objectives are to improve range of motion (ROM) and muscle strength, reduce pain and stiffness, increase pain pressure threshold, and enhance function and physical performance through GMI application.
Detailed Description
46 voluntary patients with knee OA, aged between 45-64 years will be randomly divided into two groups: GMI group and TENS group. Interventions will be applied for 8 weeks, 3 times a week (24 sessions). Both groups will receive conventional physiotherapy and home exercises in addition to GMI or TENS treatment. The patients will be assessed before, after treatment and six-week follow-up. Knee pain will be evaluated using the Visual Analog Scale (VAS), pressure pain threshold will be measured using an algometer, pain, function, and stiffness will be assessed using the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), active knee range of motion will be measured using a digital goniometer, muscle strength will be evaluated using a hand-held dynamometer, and function will be assessed using the Timed Up and Go Test.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Knee Osteoarthritis, Limitation, Mobility
Keywords
Pain, Knee Joint, Exercise, Range of Motion, Muscle Strength
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Two treatment groups have been formed to receive GMI and TENS.
Masking
Outcomes Assessor
Masking Description
The statistician will be blinded.
Allocation
Randomized
Enrollment
46 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Graded Motor Imagery
Arm Type
Experimental
Arm Description
Each patient in the Graded Motor Imagery group will receive a treatment protocol consisting of Graded Motor Imagery, conventional physiotherapy, and home exercises.
Arm Title
Transcutaneous Electrical Nerve Stimulation (TENS)
Arm Type
Active Comparator
Arm Description
Each patient in the Transcutaneous Electrical Nerve Stimulation group will receive a treatment protocol consisting of Transcutaneous Electrical Nerve Stimulation, conventional physiotherapy, and home exercises.
Intervention Type
Other
Intervention Name(s)
Graded Motor Imagery (GMI)
Other Intervention Name(s)
GMI
Intervention Description
GMI includes three stages. Each session will be 30 minutes, and the GMI program will span over 8 weeks. The first 3 weeks will focus on lateralization, followed by 3 weeks of motor imagery, and the final 2 weeks will involve mirror therapy.
Lateralization: Patients will be asked to differentiate whether the extremities shown in the Recognise™ Knee application belong to the right or left side of their body.
Motor Imagery: Patients will be instructed to imagine slowly and smoothly moving their affected extremities to the posture depicted in the photos in the Recognise™ Knee application and then returning to the starting position.
Mirror Therapy: Using a mirror measuring 90x60 cm² placed between the lower extremities, patients will be instructed to progressively move only their unaffected extremity, then their affected extremity, and finally both extremities.
Intervention Type
Other
Intervention Name(s)
Transcutaneous Electrical Nerve Stimulation (TENS)
Other Intervention Name(s)
TENS
Intervention Description
Application will be performed using a TENS device and four separate 2 × 2 inch self-adhesive electrodes. The current will be applied to the most painful area of the affected knee. The four self-adhesive electrodes will be positioned in a square pattern, approximately 5 cm apart, centered over the pain point. Conventional TENS will be applied for 30 minutes at a frequency of 100 Hz, pulse width of 100 μs, and intensity below 10% of the motor threshold.
Intervention Type
Other
Intervention Name(s)
Conventional Physiotherapy Program
Intervention Description
The routine 60-minute program for OA patients in conventional physiotherapy includes warming up, core stability, pelvic and hip stability, gluteus medius strengthening, knee control and stability (knee flexion and extension control, lunge exercises), knee strengthening exercises (wall-assisted leg press with a ball, step-ups with elastic bands), and functional exercises.
Intervention Type
Other
Intervention Name(s)
Home Exercise Protocol
Intervention Description
The home exercises will include a warm-up consisting of a 10-minute walk at a normal pace on a flat surface while gently stretching the hamstring and calf muscles. The exercises will also involve straight leg raises, terminal knee extension, isometric contractions of the quadriceps femoris and adductor muscles using a pillow for support, toe raises, single-leg standing, toe taps, and quadriceps strengthening exercises included in the session.
Primary Outcome Measure Information:
Title
Pain Intensity
Description
Visual Analogue Scale (VAS) will be used to evaluate the severity of pain felt around the knee joint. Participants will be asked to mark the severity of the pain they feel (rest, activity and night) on a 10 cm horizontal line, from 0 (no pain) to 10 (unbearable pain).
Time Frame
Baseline
Title
Pain Intensity
Description
Visual Analogue Scale (VAS) will be used to evaluate the severity of pain felt around the knee joint. Participants will be asked to mark the severity of the pain they feel (rest, activity and night) on a 10 cm horizontal line, from 0 (no pain) to 10 (unbearable pain).
Time Frame
After the 8-week intervention
Title
Pain Intensity
Description
Visual Analogue Scale (VAS) will be used to evaluate the severity of pain felt around the knee joint. Participants will be asked to mark the severity of the pain they feel (rest, activity and night) on a 10 cm horizontal line, from 0 (no pain) to 10 (unbearable pain).
Time Frame
6-week follow-up
Title
Pain Pressure Threshold
Description
The pain pressure threshold will be measured using a algometer. The pain pressure threshold will be evaluated at two points while the patient is lying in a lateral position: 1. point located 2 cm below the medial edge of the patella, and 2. point located 2 cm below the lateral edge of the patella. The evaluator will position the algometer perpendicular to each point and apply gradual pressure at a constant rate of approximately 0.5 kg/cm2/s. The pressure will be increased until the participant reports feeling pain. Each point considered for analysis will be assessed three times, and the average value will be recorded.
Time Frame
Baseline
Title
Pain Pressure Threshold
Description
The pain pressure threshold will be measured using a algometer. The pain pressure threshold will be evaluated at two points while the patient is lying in a lateral position: 1. point located 2 cm below the medial edge of the patella, and 2. point located 2 cm below the lateral edge of the patella. The evaluator will position the algometer perpendicular to each point and apply gradual pressure at a constant rate of approximately 0.5 kg/cm2/s. The pressure will be increased until the participant reports feeling pain. Each point considered for analysis will be assessed three times, and the average value will be recorded.
Time Frame
After the 8-week intervention
Title
Pain Pressure Threshold
Description
The pain pressure threshold will be measured using a algometer. The pain pressure threshold will be evaluated at two points while the patient is lying in a lateral position: 1. point located 2 cm below the medial edge of the patella, and 2. point located 2 cm below the lateral edge of the patella. The evaluator will position the algometer perpendicular to each point and apply gradual pressure at a constant rate of approximately 0.5 kg/cm2/s. The pressure will be increased until the participant reports feeling pain. Each point considered for analysis will be assessed three times, and the average value will be recorded.
Time Frame
6-week follow-up
Title
WOMAC Pain Subscale
Description
The subscale can take a score between 0-20 and evaluates pain during walking on flat ground, going up and down stairs, standing, sitting and lying down.
Time Frame
Baseline
Title
WOMAC Pain Subscale
Description
The subscale can take a score between 0-20 and evaluates pain during walking on flat ground, going up and down stairs, standing, sitting and lying down.
Time Frame
After the 8-week intervention
Title
WOMAC Pain Subscale
Description
The subscale can take a score between 0-20 and evaluates pain during walking on flat ground, going up and down stairs, standing, sitting and lying down.
Time Frame
6-week follow-up
Secondary Outcome Measure Information:
Title
Western Ontario and McMaster University Osteoarthritis Index (WOMAC)
Description
The WOMAC index will be used to evaluate pain, stiffness, and function. It contains 24 items scored from 0 to 4: 0=absent, 1=mild, 2=moderate, 3=severe, and 4=extreme.
Time Frame
Baseline
Title
Western Ontario and McMaster University Osteoarthritis Index (WOMAC)
Description
The WOMAC index will be used to evaluate pain, stiffness, and function. It contains 24 items scored from 0 to 4: 0=absent, 1=mild, 2=moderate, 3=severe, and 4=extreme.
Time Frame
After the 8-week intervention
Title
Western Ontario and McMaster University Osteoarthritis Index (WOMAC)
Description
The WOMAC index will be used to evaluate pain, stiffness, and function. It contains 24 items scored from 0 to 4: 0=absent, 1=mild, 2=moderate, 3=severe, and 4=extreme.
Time Frame
6-week follow-up
Title
Range of Motion (ROM)
Description
Knee ROM will be evaluated with a digital goniometer while the participants lie comfortably in the prone position while active knee joint motion will be evaluated. Evaluation will be performed with the pivot point following the lateral condyle of the femur, the fixed arm following the lateral midline of the femur, and the mobile arm following the fibula. The measurements will be repeated three times for the affected and unaffected side, and the best value between the measurements will be recorded.
Time Frame
Baseline
Title
Range of Motion (ROM)
Description
Knee ROM will be evaluated with a digital goniometer while the participants lie comfortably in the prone position while active knee joint motion will be evaluated. Evaluation will be performed with the pivot point following the lateral condyle of the femur, the fixed arm following the lateral midline of the femur, and the mobile arm following the fibula. The measurements will be repeated three times for the affected and unaffected side, and the best value between the measurements will be recorded.
Time Frame
After the 8-week intervention
Title
Range of Motion (ROM)
Description
Knee ROM will be evaluated with a digital goniometer while the participants lie comfortably in the prone position while active knee joint motion will be evaluated. Evaluation will be performed with the pivot point following the lateral condyle of the femur, the fixed arm following the lateral midline of the femur, and the mobile arm following the fibula. The measurements will be repeated three times for the affected and unaffected side, and the best value between the measurements will be recorded.
Time Frame
6-week follow-up
Title
Isometric Muscle Strength
Description
Flexion and extension isometric muscle strength of the knee will be assessed using a hand-held dynamometer. During the assessment, maximum voluntary contraction will be requested. Measurements will be repeated three times (5 seconds of contraction followed by 30 seconds of rest) for both affected and unaffected knees, and the average value will be recorded in Newtons (N). Patients will sit with their backs straight, arms crossed, hips flexed at 90°, and knees flexed at 30°, with their feet hanging off the side of the bed. The dynamometer will be placed on the anterior surface of the tibia, two fingers above the lateral malleolus.
Time Frame
Baseline
Title
Isometric Muscle Strength
Description
Flexion and extension isometric muscle strength of the knee will be assessed using a hand-held dynamometer. During the assessment, maximum voluntary contraction will be requested. Measurements will be repeated three times (5 seconds of contraction followed by 30 seconds of rest) for both affected and unaffected knees, and the average value will be recorded in Newtons (N). Patients will sit with their backs straight, arms crossed, hips flexed at 90°, and knees flexed at 30°, with their feet hanging off the side of the bed. The dynamometer will be placed on the anterior surface of the tibia, two fingers above the lateral malleolus.
Time Frame
After the 8-week intervention
Title
Isometric Muscle Strength
Description
Flexion and extension isometric muscle strength of the knee will be assessed using a hand-held dynamometer. During the assessment, maximum voluntary contraction will be requested. Measurements will be repeated three times (5 seconds of contraction followed by 30 seconds of rest) for both affected and unaffected knees, and the average value will be recorded in Newtons (N). Patients will sit with their backs straight, arms crossed, hips flexed at 90°, and knees flexed at 30°, with their feet hanging off the side of the bed. The dynamometer will be placed on the anterior surface of the tibia, two fingers above the lateral malleolus.
Time Frame
6-week follow-up
Title
Mini Mental State Examination
Description
The Mini-Mental State Examination (MMSE) will be used to assess the cognitive status of patients. It consists of 11 questions and is evaluated on a scale of 30 points. A score between 24-30 is considered normal, 18-23 indicates mild cognitive impairment, and a score of 17 or below is indicative of severe dementia. The MMSE assesses orientation, memory, attention, calculation, recall, language, motor function, perception, and visuospatial abilities.
Time Frame
Baseline
Title
Mini Mental State Examination
Description
The Mini-Mental State Examination (MMSE) will be used to assess the cognitive status of patients. It consists of 11 questions and is evaluated on a scale of 30 points. A score between 24-30 is considered normal, 18-23 indicates mild cognitive impairment, and a score of 17 or below is indicative of severe dementia. The MMSE assesses orientation, memory, attention, calculation, recall, language, motor function, perception, and visuospatial abilities.
Time Frame
After the 8-week intervention
Title
Mini Mental State Examination
Description
The Mini-Mental State Examination (MMSE) will be used to assess the cognitive status of patients. It consists of 11 questions and is evaluated on a scale of 30 points. A score between 24-30 is considered normal, 18-23 indicates mild cognitive impairment, and a score of 17 or below is indicative of severe dementia. The MMSE assesses orientation, memory, attention, calculation, recall, language, motor function, perception, and visuospatial abilities.
Time Frame
6-week follow-up
Title
Timed Get Up and Go Test (TUG)
Description
The test will be initiated with each participant sitting on a chair with their back supported, arms resting on their lap, and both feet flat on the floor. Participants will be timed using a stopwatch as they rise from the chair (45 cm in height), walk 3 meters as quickly and safely as possible, turn around, return to the chair, and sit down. The time taken for each participant to complete these tasks will be recorded using a stopwatch.
Time Frame
Baseline
Title
Timed Get Up and Go Test (TUG)
Description
The test will be initiated with each participant sitting on a chair with their back supported, arms resting on their lap, and both feet flat on the floor. Participants will be timed using a stopwatch as they rise from the chair (45 cm in height), walk 3 meters as quickly and safely as possible, turn around, return to the chair, and sit down. The time taken for each participant to complete these tasks will be recorded using a stopwatch.
Time Frame
After the 8-week intervention
Title
Timed Get Up and Go Test (TUG)
Description
The test will be initiated with each participant sitting on a chair with their back supported, arms resting on their lap, and both feet flat on the floor. Participants will be timed using a stopwatch as they rise from the chair (45 cm in height), walk 3 meters as quickly and safely as possible, turn around, return to the chair, and sit down. The time taken for each participant to complete these tasks will be recorded using a stopwatch.
Time Frame
6-week follow-up
10. Eligibility
Sex
All
Minimum Age & Unit of Time
45 Years
Maximum Age & Unit of Time
64 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Minimum score of 24 on the Mini Mental State Examination (indicating no mild or severe dementia)
Diagnosis of moderate unilateral knee osteoarthritis persisting for more than 12 months according to American College of Rheumatology (ACR) criteria
Experience of pain with a severity rating of 3 or higher on the Visual Analog Scale (VAS) for activities such as stair climbing, sitting, and squatting, lasting for at least 6 months (moderate to severe pain)
Age between 45 and 64 years
Residing in the city where the study is conducted
Ability to walk independently
Presence of limitations in knee range of motion (ROM)
Symptomatic and radiographically confirmed OA diagnosis of Kellgren and Lawrence grade I-III
Exclusion Criteria:
Patients who are unwilling to participate in the study
Patients presenting with secondary OA due to conditions such as rheumatoid arthritis, gout, septic arthritis, tuberculosis, tumor, trauma, hemophilia, major medical or psychiatric disorders, recent fractures, presence of effusion or open reduction and internal fixation in the knee
Presence of a neuromuscular disease
History of intra-articular injections in the past 6 months
Patients undergoing medication changes
Presence of any chronic illness that would hinder participation in the treatment program
Participation in a physiotherapy program for OA in the last 12 weeks
Movement limitations or limb deficiency in the contralateral lower extremity
Presence of visual or hearing problems that would affect treatment adherence.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Semih Ak, Dr
Phone
+905335130510
Email
mdsemihak@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Zeynep Yıldız Kızkın, PhD
Organizational Affiliation
Artvin Coruh University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Artvin State Hospital
City
Artvin
ZIP/Postal Code
08000
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Semih Ak, Dr
Phone
+905335130510
Email
mdsemihak@gmail.com
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
The Effect of Graded Motor Imagery on Pain and Function in Individuals With Knee Osteoarthritis
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