| CTRI Number |
CTRI/2024/04/065377 [Registered on: 08/04/2024] Trial Registered Prospectively |
| Last Modified On: |
05/04/2024 |
| 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
|
Early balance Training Influence on Total Knee Replacement Rehabilitation on level of pain and knee movement.
|
|
Scientific Title of Study
|
Effect of Early Proprioceptive Training in Rehabilitation of Total Knee Replacement On Pain, Range of Motion, Muscle Strength and Gait – A Randomized Controlled Trial. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Anjali Vikas Nawkhare |
| Designation |
PG Student |
| Affiliation |
Datta Meghe Institute Of Higher Education And Research |
| Address |
Department of Musculoskeletal Physiotherapy, Room Number 16, Ravi Nair Physiotherapy College, Datta Meghe Institute Of Higher Education And Research Sawangi Wardha
Wardha
MAHARASHTRA
442001
India |
| Phone |
7387207349 |
| Fax |
|
| Email |
anjalinawkhare@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Pratik Phansopkar |
| Designation |
Professor & HOD |
| Affiliation |
Datta Meghe Institute Of Higher Education And Research |
| Address |
Department of Musculoskeletal Physiotherapy, Room Number 16, Ravi Nair Physiotherapy College, Datta Meghe Institute Of Higher Education And Research Sawangi Wardha.
Wardha
MAHARASHTRA
442001
India |
| Phone |
9890827710 |
| Fax |
|
| Email |
drpratik77@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Pratik Phansopkar |
| Designation |
Professor & HOD |
| Affiliation |
Datta Meghe Institute Of Higher Education And Research |
| Address |
Department of Musculoskeletal Physiotherapy, Room Number 16, Ravi Nair Physiotherapy College, Datta Meghe Institute Of Higher Education And Research Sawangi Wardha
Wardha
MAHARASHTRA
442001
India |
| Phone |
9890827710 |
| Fax |
|
| Email |
drpratik77@gmail.com |
|
|
Source of Monetary or Material Support
|
| Ravi Nair Physiotherapy College, Acharya Vinoba Bhave Rural Hospital,Datta Meghe Institute Of Higher Education And Research [ Deemed To Be University], Sawangi Meghe Wardha, Maharashtra, India. |
|
|
Primary Sponsor
|
| Name |
Ravi Nair Physiotherapy College |
| Address |
Department Of Musculoskeletal Physiotherapy, Ravi Nair Physiotherapy College,Datta Meghe Institute Of Higher Education And Research [ Deemed To Be University], Sawangi Wardha.
|
| Type of Sponsor |
Research institution and hospital |
|
|
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 Anjali Vikas Nawkhare |
Acharya Vinoba Bhave Rural Hospital,Ravi Nair Physiotherapy College |
In Patient Department Orthopedic Ward IPD No.33 TKR & THR Department, Room Number D/201, Department Of Musculoskeletal Physiotherapy, Ravi Nair Physiotherapy College, Datta Meghe Institute Of Higher Education And Research [ Deemed To Be University], Sawangi
Wardha
MAHARASHTRA |
7387207349
anjalinawkhare@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Datta Meghe Institute Of Higher Education And Research [ Deemed To Be University],INSTITUTE OF ETHICS COMMITTEE |
Approved |
|
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Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M171||Unilateral primary osteoarthritisof knee, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Combined kinetic chain exercise (CCE) |
The Control Group had a 4-week treatment protocol receiving a combined kinetic chain exercise (CCE). The main focus was CCE (Combined Kinematic Chain Exercise) training for physical function, balance ability, and gait. This group of patients will be receiving only combined kinetic chain exercise (CCE).
Combined kinematic chain exercise this protocol follows a 4week treatment protocol with 10 times,2 set : Quadriceps setting in the supine position,
Ankle full exercise in a supine, Wall slide, Getting up and down from a chair, Quadriceps setting while sitting, Getting up and down from a chair, Standing up and off heels, Wall squat, Stepping up and down the step box forward and sideward, Getting up and down from a chair, Hip abduction exercise while standing, Stepping up and down from a step box forward and sideward, Mini squat with a walker, Toe gait. |
| Intervention |
Proprioceptive rehabilitation along with Combined Kinematic Chain Exercises |
In the interventional group, a 4-week treatment protocol focuses on physical function, knee flexion, balance, and gait through Proprioceptive rehabilitation along with Combined Kinematic Chain Exercises (CCE). The goal is to achieve early walking and balance. The program includes:
Combined kinematic chain exercise this protocol follows a 4-week treatment protocol with 10 times,2 set: Quadriceps setting in the supine position,
Ankle full exercise in a supine, Wall slide, Getting up and down from a chair, Quadriceps setting while sitting, Getting up and down from a chair, Standing up and off heels, Wall squat, Stepping up and down the step box forward and sideward, Getting up and down from a chair, Hip abduction exercise while standing, Stepping up and down from a step box forward and sideward, Mini squat with a walker, Toe gait.
In proprioceptive training follows a 4-week treatment protocol with 10 times,1 set /2set : Standing ( eye open & eye closed), Two-leg stance, Single leg stance stable surface ( eye open - eye closed), Double leg squat with walker, Single leg stance on balance pad progress, Double leg squat unstable surface, Single leg stance with ball toss, Side to side step on bosu, Squat on bosu, Lunges on bosu. |
|
|
Inclusion Criteria
|
| Age From |
50.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Both male and female participants
The patient who has been operated on for TKR.
Bicompartmental, Tricompartmental & Unicompartmental total knee replacement.
Those who have been referred to physiotherapy.
Uncemented & Cemented implant. |
|
| ExclusionCriteria |
| Details |
The patient has superficial and deep sensory impairments.
Patients with hip problems underwent TKR.
Patient with plantar fasciitis
Current participation in another OA intervention study.
Severe physical disabilities (i.e., not able to walk even with a walking aid).
Patients are not willing to participate in the study. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Pain
Knee Range of motion
Gait
Muscle Strength |
Baseline and after 4 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Muscle Strength
Time up & go scale |
Baseline and after 4 weeks |
|
|
Target Sample Size
|
Total Sample Size="52"
Sample Size from India="52"
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 2/ Phase 3 |
|
Date of First Enrollment (India)
|
25/05/2024 |
| 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="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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 study aims to find out the effect of early intervention using proprioceptive training along with CCE (Combined Kinematic Chain Exercise) in subjects who underwent Total Knee Replacement (TKR). The randomized controlled trial involves 52 TKR patients aged 50-65 years, with half receiving proprioceptive training with Combined Kinematic Chain Exercise (CCE) and the other half receiving Combined Kinematic Chain Exercise (CCE) alone. After TKR patient has experienced difficulty in knee flexion, and walking. Reduces strength and ROM. Our focus will be on improving their balance, gait, and knee ROM. Proprioceptive training is known to enhance movement quality and promote energy-efficient movement patterns, which are crucial for TKR patients. Therefore, this study will explore more effective rehabilitation techniques following TKR to improve patient outcomes. Outcome measures include pain, knee range of motion, muscle strength, gait and functional mobility it will be assessed before and after 4 weeks of intervention. The study seeks to enhance rehabilitation protocols and improve patient outcomes following TKR. |