FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2024/07/070455 [Registered on: 11/07/2024] Trial Registered Prospectively
Last Modified On: 17/04/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Physiotherapy (Not Including YOGA) 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Impact of Cognitive-Motor Dual Tasks on Balance in Individuals with Knee Osteoarthritis 
Scientific Title of Study   Effect Of Cognitive- Motor Dual Task On Balance In Osteoarthritis Of Knee 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Anyushka Sivaraj 
Designation  PG Student 
Affiliation  St Johns Medical College Hospital 
Address  Room no:30 St Johns Medical College Hospital, Department of Physiotherapy,Sarjapur Marathahalli Rd, beside Bank of Baroda,John Nagar , Koramangala,Bengaluru

Bangalore
KARNATAKA
560034
India 
Phone  09769335275  
Fax    
Email  anyushka07@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Sneha Vishwanath 
Designation  Associate Professor 
Affiliation  St Johns Medical College Hospital 
Address  Room no:30 St Johns Medical College Hospital, Department of Physiotherapy,Sarjapur Marathahalli Rd, beside Bank of Baroda,John Nagar , Koramangala,Bengaluru

Bangalore
KARNATAKA
560034
India 
Phone  9739314175  
Fax    
Email  snehapt@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Anyushka Sivaraj 
Designation  PG Student 
Affiliation  St Johns Medical College Hospital 
Address  Room no:30 St Johns Medical College Hospital, Department of Physiotherapy,Sarjapur Marathahalli Rd, beside Bank of Baroda,John Nagar , Koramangala,Bengaluru

Bangalore
KARNATAKA
560034
India 
Phone  9769335275  
Fax    
Email  anyushka07@gmail.com  
 
Source of Monetary or Material Support  
St Johns Medical College Hospital Department of Physiotherapy, Sarjapur Marathahalli Rd, beside Bank Of Baroda, John Nagar, Koramangala, Bengaluru, Karnataka , India 
 
Primary Sponsor  
Name  not applicable 
Address  not applicable 
Type of Sponsor  Other [not applicable] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
DrSneha Vishwanath  St Johns Medical College Hospital   Room No:32 Department of Physiotherapy, Sarjapur Marathahalli Rd, beside Bank Of Baroda, John Nagar, Koramangala, Bengaluru, Karnataka 560034
Bangalore
KARNATAKA 
9739314175

snehapt@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee St Johns Medical College  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: M170||Bilateral primary osteoarthritis of knee,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Balance Exercises and Conventional Treatment  Each session will be 45 minutes , with three sessions in one week Session 1 TENs for 10 mins on the affected knee joint Strengthening Exercise Isometrics of quadriceps, Straight Leg Raises, Side lying Abductions for 10 repetitions Balance exercises Weight shifting (Anterior, Posterior, Lateral direction) Semi-tandem, Tandem stance Session 2 TENs for 10 mins on the affected knee joint Quadriceps strengthening with foam roller under the knee Wall supported squats for 10 repetitions Balance exercises Marching in place Unilateral Stance Lateral walking, backward walking Standing on a Bosu Ball Session 3 TENs for 10 mins on the affected knee joint Dynamic quadriceps with resistance band Balance exercises Cone step overs (forward) Figure of eight walking Tandem walking Step ups on the Bosu ball 
Intervention  Cognitive Motor Dual tasks  The subjects will be given the conventional treatment and a cognitive motor dual task will be added to their balance exercises Each session will be 45 minutes, with 3 sessions in one week Session 1 The type of cognitive task that will be used in this study consists of counting backwards in 2’s or 3’s within given set of number (e.g. From 20-100) A string of three-digit numbers, each number is told to the subject before the exercise and then the patient will be asked about the three-digit number after the task. Session 2 Before the exercise, a figure is chosen randomly and the subject is asked to focus on predetermined figure and at the end of exercise, provide the total number of determined figure repetitions . A different numerical string is use for each exercise. The subjects will not be allowed to use their fingers for counting and calculating because it can affect the body swing and the maximum cognitive effort of the person. Session 3 Another type of continuous cognitive task that will be used in this study includes a number of simple mathematical equations (for example, 3÷3×5+2) where each equation is present at an interval of 3 seconds by an audio tape /image during each exercise. A different set of equations will be used for each of the balance exercises. 
 
Inclusion Criteria  
Age From  45.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  Kellgren and Lawrence criteria Grade 2 and Grade 3 Knee OA patients
Grade 2: Definite osteophytes and possible narrowing of joint space
Grade 3: Moderate multiple osteophytes
Chronic pain
 
 
ExclusionCriteria 
Details  Presence of secondary osteoarthritis conditions like hip osteoarthritis, rheumatoid arthritis
Surgery done for Knee osteoarthritis
Fracture of the lower limb in past one year
Neurological disorders
Inner ear and visual acuity problems
Any previous condition affecting balance Patients/subjects on any drugs which can precipitate balance deficits.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Balance  Baseline and one week 
 
Secondary Outcome  
Outcome  TimePoints 
Functional performance  Baseline and one week 
 
Target Sample Size   Total Sample Size="40"
Sample Size from India="40" 
Final Enrollment numbers achieved (Total)= "30"
Final Enrollment numbers achieved (India)="30" 
Phase of Trial   N/A 
Date of First Enrollment (India)   21/07/2024 
Date of Study Completion (India) 28/02/2025 
Date of First Enrollment (Global)  21/07/2024 
Date of Study Completion (Global) 28/02/2025 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

Knee osteoarthritis is a degenerative joint disease that commonly affects the elderly, characterized by the gradual deterioration of articular cartilage. It can be classified into primary osteoarthritis, which has no identifiable cause, and secondary osteoarthritis, resulting from factors such as abnormal force distribution across the joint (e.g., post-traumatic causes) or conditions affecting cartilage like rheumatoid arthritis (RA). Symptoms include gradually increasing knee pain, stiffness, and swelling, which can significantly impact daily activities and potentially lead to disability over time. Osteoarthritis (OA) affects 7% of the global population, with 73% of those affected being over 55 years old and 60% being female. In India, OA is highly prevalent, affecting 22% to 39% of the population.

Patients with knee OA often experience deficits in proprioception, leading to abnormal joint loading and slow, progressive joint degeneration. Additionally, these patients typically have reduced muscle strength, particularly in the quadriceps, and altered muscle activation patterns, contributing to poor balance. Balance maintenance involves the vestibular system, vision, proprioception, muscle strength, and cognitive functions. Studies show that individuals with knee OA have impaired proprioception compared to peers of similar age, with histological examinations indicating fewer mechanical sensory receptors around the knee ligaments. Since the knee is a frequently injured weight-bearing joint and OA increases fall risk, educating patients on fall prevention and providing balance-specific rehabilitative training is essential.

Patients with chronic pain, including OA, often perform poorly on tests assessing attention and memory, indicating cognitive deficits. Sensory, motor, and cognitive functions in knee OA patients are generally worse than in healthy individuals, which may contribute to balance impairments. The cognitive-motor dual task method, derived from the dual-task paradigm, is used for balance training and hypothesizes that adding a continuous cognitive task to balance exercises enhances performance by promoting task automaticity. Automaticity refers to the execution of a skill with minimal attentional demand, whereas non-automated tasks require significant attention. Logan et al. propose that automaticity exists on a continuum, with tasks varying in their degree of automation.

The constrained-action hypothesis by Wulf et al. suggests that conscious control of movements constrains the motor system, interfering with automatic motor control processes. Focusing on the movement effect, however, may allow the motor system to self-organize more naturally, leading to more effective performance and learning. Previous studies have shown positive effects of cognitive-motor dual tasks on balance in ACL patients. Chronic pain patients, including those with OA, often display cognitive deficits due to pain’s demand on attention, which competes with other cognitive tasks. These patients also show reduced reaction times and compromised perceptual-motor coordination.

This study aims to evaluate the effect of cognitive-motor dual task training on balance in adults with knee osteoarthritis, addressing a gap in the literature regarding this specific patient population. The goal is to assess whether this training improves postural stability in knee OA patients.

Need for the Study: To the best of my knowledge there is a lack of literature on the impact of cognitive-motor dual task training on balance in knee osteoarthritis, despite evidence of its benefits in conditions like ACL injuries and chronic ankle instability. This study seeks to fill that gap and provide insights into improving balance in knee OA patients.

Aim of the Study: To evaluate the effect of cognitive-motor dual task training on balance in individuals with knee osteoarthritis.



 
Close