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CTRI Number  CTRI/2024/12/077812 [Registered on: 06/12/2024] Trial Registered Prospectively
Last Modified On: 10/12/2024
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Physiotherapy (Not Including YOGA) 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Impact of weight bearing Exercises and core stability on Pain Relief and Physical Function in Knee Osteoarthritis 
Scientific Title of Study   Effects of PNF(Proprioceptive Neuromuscular Facilitation) stretching, proprioceptive exercises, and core stability exercises on pain and physical function in knee osteoarthritis 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Vaibhavi Arun Pawar 
Designation  Student 
Affiliation  Dr APJ Abdul Kalam College Of Physiotherapy loni 
Address  Dr. APJ Abdul Kalam College Of Physiotherapy , 403, orthopedic physiotherapy department ,loni , Ahmednagar

Ahmadnagar
MAHARASHTRA
413736
India 
Phone  7350828697  
Fax    
Email  vaibhavip1003@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Tejas Borkar PT 
Designation  Assosciate Professor 
Affiliation  Dr APJ Abdul Kalam College Of Physiotherapy loni 
Address  Dr. APJ Abdul Kalam College Of Physiotherapy , 504, pediatrics physiotherapy department , loni , Ahmednagar

Ahmadnagar
MAHARASHTRA
413736
India 
Phone  93712771752  
Fax    
Email  tejasborkar57@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Vaibhavi Arun Pawar 
Designation  Student 
Affiliation  Dr APJ Abdul Kalam College Of Physiotherapy loni 
Address  Dr. APJ Abdul Kalam College Of Physiotherapy , 403, orthopedic physiotherapy department ,loni , Ahmednagar

Ahmadnagar
MAHARASHTRA
413736
India 
Phone  7350828697  
Fax    
Email  vaibhavip1003@gmail.com  
 
Source of Monetary or Material Support  
Dr. APJ Abdul Kalam College of Physiotherapy, Pravara Institute of Medical Sciences, Loni,413736 
 
Primary Sponsor  
Name  Dr. A.P.J Abdul Kalam College of Physiotherapy, PIMS , Loni 
Address  Pravara Institute of Medical Sciences, Dr. A.P.J Abdul Kalam College of Physiotherapy , Loni, 413736 
Type of Sponsor  Private medical college 
 
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 
Vaibhavi Pawar  Dr. A.P.J Abdul Kalam College of Physiotherapy, loni Ahmed Nagar   Dr. APJ Abdul Kalam College Of Physiotherapy , 403, orthopedic physiotherapy department ,loni , Ahmednagar
Ahmadnagar
MAHARASHTRA 
7350828697

vaibhavip1003@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional ethical committee, Dr. APJAK COPT  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Osteoarthritis 
Patients  (1) ICD-10 Condition: M00-M99||Diseases of the musculoskeletal system and connective tissue,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Proprioceptive Neuromuscular Facilitation  Hamstrings Stretch Quadriceps Stretch Medial and lateral knee stretches Static balance on unstable surfaces (balance board)2 sets of 10 reps TENS Week 1 to 2: - Frequency – 3 sessions / week Intensity – moderate Time – 30 minutes Type – stretching (hold 20 secs 2 sets) -Modality (7 minute) (10 reps 2 sets for each exercises)  
Comparator Agent  Proprioceptive Neuromuscular Facilitation with core stability   core stability exercise 
 
Inclusion Criteria  
Age From  45.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  1) 45 to 65 years of age
2) Both male and female
3) Diagnosed case of knee OA
4) Non operative OA patients 
 
ExclusionCriteria 
Details  1) post operative OA
2) History of dislocation
3) History of fracture
4) History of trauma
5) Not willing to participate 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
1] Senior fitness test – Timed up and go test
30 second chair stand test
2]WOMAC scale
 
week 0 to week 4
 
 
Secondary Outcome  
Outcome  TimePoints 
NIL  NIL 
 
Target Sample Size   Total Sample Size="50"
Sample Size from India="50" 
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   Phase 1/ Phase 2 
Date of First Enrollment (India)   16/12/2024 
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="6"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details
Modification(s)  
N/A 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary
Modification(s)  

Introduction:

 The most prevalent joint condition, osteoarthritis (OA), mostly affects the diarthrodial joints and is linked to a growing socioeconomic burden as a result of population aging. Increasing age and obesity are the two main risk factors for primary OA, however there are other factors as well. From being thought of as a cartilage-limited condition to a multifactorial illness affecting the entire joint, the idea of the pathogenesis is continually changing.

Proprioceptive neuromuscular facilitation, or PNF stretching, is a type of flexibility training that helps lessen hyper tonus, enabling muscles to loosen up and lengthen. In order to maximize motor performance and facilitate rehabilitation, proprioceptive neuromuscular facilitation (PNF) stretching techniques are frequently employed in clinical and sporting settings to improve both active and passive range of motion.

 PNF methods aid in the development of joint stability, mobility, neuromuscular control, and coordination as well as muscle strength and endurance. In order to maximize motor performance and facilitate rehabilitation, proprioceptive neuromuscular facilitation (PNF) stretching techniques are frequently employed in clinical and sporting settings to improve both active and passive range of motion. 2

Techniques-- Contract Relax: The restricted muscle is passively stretched into a stretched posture, and then it is isometrically contracted. In PNF stretching techniques, the majority of isometric contractions should be held for at least three seconds.

Hold Relax: This method is really comparable to Contract Relax. When the agonist is too weak to activate effectively, this is used. The patient is made to stretch their restricted muscle, and then they are made to contract isometrically. Most recognizable opponent for hold-relax. It can be applied to improve passive range of motion and extend tense muscles. Since the tight muscle in this approach is the antagonist, the agonist contracts.

Hold-Relax Agonist: Most familiar. It can be used to lengthen out tight muscle and increase passive range of motion. In this technique, the tight muscle is the antagonist, hence the agonist contracts.

The cornerstone of the treatment is physiotherapy. It includes stretching and strengthening exercises, thermotherapy, and electrotherapy (ultrasound, muscle stimulation). Additionally, braces and other supportive devices are used.

 The Proprioceptive Neuromuscular Facilitation (PNF) stretching technique has been demonstrated to enhance both passive and active range of motion while also increasing muscle flexibility. Proprioceptive neuromuscular facilitation (PNF) stretching may be a preferred intervention for KOA rehabilitation. PNF stretching was more effective than traditional stretching for pain relief.


Weakness in the core muscles puts more strain on the knee joint and its contact when walking. Activating the functional kinetic chain that links the stability of the lower extremities is a component of strengthening core muscles

NEED FOR STUDY:

 As the population ages, osteoarthritis (OA), the most prevalent joint condition, is linked to a growing socioeconomic effect and primarily affects the diarthrodial joints. A number of risk factors contribute to primary OA, the two most common ones being obesity and advancing age. There are very few studies are done on stepping mechanism on osteoarthritis patient so, the need of study is to find out effect of proprioceptive neuromuscular facilitation (PNF) stretching in reducing pain and improving knee balance with knee osteoarthritis (OA). The study aims to investigate the effectiveness of proprioceptive neuromuscular facilitation (PNF) stretching and proprioceptive exercises along with core stability on pain and physical function in patients with knee osteoarthritis(OA).

RESEARCH QUESTION:

 Will there any effect of proprioceptive neuromuscular facilitation and proprioceptive exercises along with core stability on pain and physical function in knee osteoarthritis(OA)?

AIM: To find the effect of proprioceptive neuromuscular facilitation and proprioceptive exercises along with core stability on pain and physical function in knee osteoarthritis(OA).

 

OBJECTIVE OF THE STUDY:

.      To find effect of PNF and proprioceptive exercises along with core stability on pain.

.      To find effect of PNF and proprioceptive exercises along with core stability on physical function.

HYPOTHESIS

H0: Null Hypothesis

There is no significant effect of proprioceptive neuromuscular facilitation and proprioceptive exercises along with core stability on pain and physical function in knee osteoarthritis(OA).

H1: alternative Hypothesis

There is significant   effect of proprioceptive neuromuscular facilitation and proprioceptive exercises along with core stability on pain and physical function in knee osteoarthritis(OA).

METHODOLOGY:  

            STUDY SETTING: Dr. A.P.J. Abdul Kalam College of Physiotherapy.

            DURATION OF STUDY: 4 weeks

            METHOD OF COLLECTION OF DATA:   Dr. A.P.J. Abdul Kalam College of Physiotherapy

            TYPE OF DATA: quantitative

            STUDY DESIGN: Randomize control trial

            STUDY TYPE: Intervention

            SAMPLING METHOD: simple random sampling

OUTCOME MEASURES:                           

1] Senior fitness test – Timed up and go test

                                     30 second chair stand test

2] WOMAC Scale

Inclusion criteria: 

1.45-65 years of age

2. Both male and female

3. Diagnosed case of Knee OA

4. Non operative OA patients.

Exclusion criteria:

1. post-operative OA

2. History of fracture

3. History of dislocation

4. History of trauma

5. Not willing to participate

PROCEDURE:

Protocol is prepared and ethical will be obtained from the IEC.

The participants will be selected based on the eligibility criteria.

Informed consent will be obtained from the participants and demographic data will be recorded

Participants will be randomly allocated to 2 group that is experimental group A(n=) and control group B(n=) prior assessment of the participant will be done

Group A will be administered with proprioceptive neuromuscular facilitation stretching to

Quadriceps, hamstrings and conventional physiotherapy treatment.

Group B will be administered with proprioceptive exercises with core stability.

All the instruction will be given verbally, provided demonstration and guided through a single practice trial.

REFERENCES:

1. Martel-Pelletier J, Barr AJ, Cicuttini FM, Conaghan PG, Cooper C, Goldring MB, Goldring SR, Jones G, Teichtahl AJ, Pelletier JP. Osteoarthritis. Nat Rev Dis Primers. 2016 Oct 13; 2:16072. doi: 10.1038/nrdp.2016.72. PMID: 27734845.

2. Nathani S, Tank KD. Effect of PNF stretching on proprioception and physical function in individual with knee osteoarthritis: An experimental study. Indian Journal of Public Health Research & Development. 2020 Jul 30;11(7):712-7.

3. Gao B, Li L, Shen P, Zhou Z, Xu P, Sun W, Zhang C, Song Q. Effects of proprioceptive neuromuscular facilitation stretching in relieving pain and balancing knee loading during stepping over obstacles among older adults with knee osteoarthritis: A randomized controlled trial. Plos one. 2023 Feb 13;18(2): e0280941.

4. Salehi N, Mohammadi HR, Poursamad A, Afrasiabifar A, Doulatabad SN. The Effect of Proprioceptive Neuromuscular Facilitation Techniques on Muscular Strength in Patients with Knee Osteoarthritis: A Quasi-Experimental Study. Jundishapur Journal of Chronic Disease Care. 2024;13(2).

5. Shen S, Mulgaonkar Y, Michael N, Kumar V. Multi-sensor fusion for robust autonomous flight in indoor and outdoor environments with a rotorcraft MAV. In2014 IEEE International Conference on Robotics and Automation (ICRA) 2014 May 31 (pp. 4974-4981). IEEE.






 
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