| 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
|
|
|
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
|
|
|
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.
|
|
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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
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Brief Summary
|
|