| CTRI Number |
CTRI/2025/04/085781 [Registered on: 28/04/2025] Trial Registered Prospectively |
| Last Modified On: |
27/04/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Effectiveness of proprioceptive exercises and balance training on pain functional disability and performance in patients with osteoarthritis of knee. |
|
Scientific Title of Study
|
Efficacy of Proprioceptive exercises and Balance training on Pain, Functional disability and Performance in patients with Knee Osteoarthritis-A
randomized controlled trial. |
| Trial Acronym |
NILL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Taruna Verma |
| Designation |
Associate Professor |
| Affiliation |
Galgotias University. |
| Address |
room no-B228 Department of physiotherapy,school of Allied Health Science, opposite Buddha International Circuit, Sector 17A, Greater Noida, Uttar Pradesh 203201.
Gautam Buddha Nagar
UTTAR PRADESH
203201
India |
| Phone |
7988151951 |
| Fax |
|
| Email |
drtarunaverma21@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Taruna Verma |
| Designation |
Associate Professor |
| Affiliation |
Galgotias University. |
| Address |
room no-B228 Department of physiotherapy,school of Allied Health Science, opposite Buddha International Circuit, Sector 17A, Greater Noida, Uttar Pradesh 203201.
Gautam Buddha Nagar
UTTAR PRADESH
203201
India |
| Phone |
7988151951 |
| Fax |
|
| Email |
drtarunaverma21@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Shubham Kumar Roy |
| Designation |
Student |
| Affiliation |
Galgotias University |
| Address |
room no-B228 Department of physiotherapy,school of Allied Health Science, opposite Buddha International Circuit, Sector 17A, Greater Noida, Uttar Pradesh 203201.
Gautam Buddha Nagar
UTTAR PRADESH
203201
India |
| Phone |
9366022584 |
| Fax |
|
| Email |
royshubham073@gmail.com |
|
|
Source of Monetary or Material Support
|
| Departmental Research Committee, Department of Physiotherapy, School of Allied Health Sciences, Galgotias University, sector 17A greater noida, uttar pradesh (201310), Uttar Pradesh. |
|
|
Primary Sponsor
|
| Name |
Galgotias University |
| Address |
Plot No.2, Sector 17-A Yamuna Expressway, Greater Noida, pin code-203201,Gautam Buddh Nagar,Uttar Pradesh,India. |
| Type of Sponsor |
Research institution |
|
|
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 |
| Dr Taruna Verma |
Galgotias University |
Room no-B228, Department of physiotherapy, School of Allied science, galgotias University, Plot no 2, sector 17A, Opposite Buddha International Circuit, Greater Noida, G.B Nagar, Uttar Pradesh, India 203210
Gautam Buddha Nagar
UTTAR PRADESH |
7988151951
drtarunaverma21@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Departmental Research Committee, Department of Physiotherapy, School of Allied Health Sciences, Galgotias University |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M179||Osteoarthritis of knee, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Balance Training |
• Balance training exercises: Balance Exercise Program includes 1. Up and down on a
standard four-step staircase 2. placing your feet at shoulder-width apart while standing,
stretch your hands just front of your shoulder. Try to maintain the position for 10s while
earlier exercises while standing with your feet shoulder-width apart. Try to maintain the
stance for 10s by placing one foot inside the other’s ankle. 4. Hold a one-legged standing
with one foot lifted behind you and the other leg bent 90 degrees. Try to hold that position
for at least three seconds. 5. Stand with your feet slightly wider than your shoulders and
your hands behind your back. Try to maintain the position for 10s while lifting both heels
off the ground. 6. Repeat the previous exercise while lifting one foot in front with the non
weight-bearing knee flexed and raised to the height of the hip. 7. Along a line drawn on a
typical floor, step from heel to toe.
• Duration: Each exercise was done for 5 minutes with one minute rest in between for a
45-minutes treatment session
|
| Intervention |
Proprioceptive exercises |
Proprioception Exercise: Exercises included 1.One leg balance, 2.Forward leg swings with knee
extension, 3.Backward leg swings with knee flexion, 4.Toe walking, 5.Heel walking, 6.Cross body
leg swing right side, 7.Cross body leg swing left side, 8.Partial squat, 9.Blind advanced one leg
balance, 10.Side lunge.
• Duration: Each exercise was done for 5 minutes with 1 minute rest in between for a 45-minutes
treatment session. |
|
|
Inclusion Criteria
|
| Age From |
45.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1.Age: Aged group between 45-65 years
2.Gender: Male and Female
3.Knee pain more than 6 Weeks
4.Bilateral and unilateral involvement
5.Morning stiffness lasting more than 30 minimum
Bony tenderness and enlargement
6.Restricted range of motion |
|
| ExclusionCriteria |
| Details |
1. Subjects who are not willing to participate.
2. Lower extremity arthritis or pain that limits standing or weight bearing will be excluded.
3. Patients who are visually impaired as it may affect walking.
4. Severe cardiopulmonary insufficiency and Psychiatric illness.
5. Subjects who have recently undergone knee replacement or ligament surgery of ankle
spine and hip in past 6 months.
6. Neurological impairments, cardiovascular and respiratory disease.
7. History of knee surgery, tumors or malignancy of bones will be excluded.
8. Patients with severe pain (greater than 7 on the Numerical Pain Rating Scale)
9. Obesity (body mass index greater than 25 kg/m2)
10. Congenital deformities, other systemic arthritis in walking for 10 min continuously.
11. History of lower limb trauma or surgery in the last 6 months |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Pain Intensity(VAS)-Measure reduction in pain using VAS Scale.
Knee Range of Motion-Assess improvement in knee mobility.
physical functioning questions |
at baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Physical functioning questions
Western Ontario & Mcmaster Osteoarthritis Index (WOMAC),
Numerical Pain Rating Scale (NPRS)
Time Up & Go Test (TUG). |
at baseline |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
12/05/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="3"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
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
|
The main aim of the study is to assess the Efficacy of Proprioceptive exercises and Balance training on Pain Functional disability and performance in Patients with Osteoarthritis.Osteoarthritis (OA) is a long-term, degenerative, and inflammatory condition affecting the musculoskeletal system. It leads to pain, decreased functional abilities, and a reduced quality of life, making rehabilitation challenging. OA is the second most common rheumatic condition, following soft tissue rheumatism. It is also the most prevalent rheumatic disease and a major cause of pain and disability.
Various treatment approaches have been developed to manage pain and enhance joint mobility. Analgesics are commonly prescribed to alleviate osteoarthritic pain, but their use is limited due to side effects and only temporary relief. Other therapeutic methods include local injections and surgeries. Physical therapy for OA in the knee aims to reduce pain and stiffness, preserve and enhance joint mobility, reduce physical disability, improve the health-related quality of life, and slow joint deterioration .Balance training plays a crucial role in preventing falls. Proprioceptive exercises focus on joint position awareness, which helps maintain joint stability and posture, thereby improving the somatosensory system . This study is an experimental research that seeks to evaluate the effects of Efficacy of Proprioceptive exercises and Balance training on Pain Functional disability and performance in Patients with Osteoarthritis. The study was performed in Greater Noida and will examine whether Proprioceptive exercise or Balance training have more effect in improving pain and performance in patients with osteoarthritis of knee. The study will require a total of 64 patients suffering from osteoarthritis of knee. These participants will be randomly divided into two groups: the Proprioceptive Exercise group (32 people) and a Balance Training group (32 people). Patients in both groups received information regarding osteoarthritis of the knee as well as protective suggestions (ergonomic advices) for the knee. The pre- test was assessed by WOMAC index and TUG test, and the post test will be assessed at the sixth week’s end. The subjects received the treatment for six weeks of three sessions per week. The subjects in group A, received the conventional treatment (modalities + conventional exercise) along with proprioceptive exercise; The subjects in Group B, received the conventional treatment along with Balance training, six weeks of three exercise sessions per week, and the participants were reassessed after six weeks with WOMAC questionnaire and TUG test. The conventional exercises integrated in both the groups included: isometric quadriceps, isometric hamstrings, tendo-achilles stretching, hamstrings stretching and vastusmedialis stretching. Each exercise was performed for 10 repetitions.
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