| CTRI Number |
CTRI/2025/02/080612 [Registered on: 14/02/2025] Trial Registered Prospectively |
| Last Modified On: |
17/01/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Effect of Dynamic Joint Position Sense Exercises Versus Static Joint Position Sense Exercises in Joint Position on Unilateral Osteoarthritis Subjects |
|
Scientific Title of Study
|
Effectiveness of Dynamic Joint Position Sense (JPS) Exercises Versus Static Joint Position Sense Exercises in JPS on Unilateral Osteoarthritis Subjects |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
PRASANNA KUMAR R |
| Designation |
PG STUDENT |
| Affiliation |
SAVEETHA COLLEGE OF PHYSIOTHERAPY, SIMATS |
| Address |
Room no.A5,
5th floor,
Health Science block,
Saveetha college of Physiotherapy,
Saveetha nagar,
Thandalam,
Kancheepuram,
Tamil Nadu -602105
India
Kancheepuram TAMIL NADU 602105 India |
| Phone |
9962702547 |
| Fax |
|
| Email |
prasannaram1809@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
K Kotteeswaran |
| Designation |
Professor |
| Affiliation |
Saveetha College of Physiotherpay |
| Address |
Room no.A5,
5th floor,
Health Science block,
Saveetha college of Physiotherapy,
Saveetha nagar,
Thandalam,
Kancheepuram,
Tamil Nadu -602105
India
Kancheepuram TAMIL NADU 602105 India |
| Phone |
9894286700 |
| Fax |
|
| Email |
k.kotteeswaran@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
K Kotteeswaran |
| Designation |
Professor |
| Affiliation |
Saveetha College of Physiotherpay |
| Address |
Room no.A5,
5th floor,
Health Science block,
Saveetha college of Physiotherapy,
Saveetha nagar,
Thandalam,
Kancheepuram,
Tamil Nadu -602105
India
Kancheepuram TAMIL NADU 602105 India |
| Phone |
9894286700 |
| Fax |
|
| Email |
k.kotteeswaran@gmail.com |
|
|
Source of Monetary or Material Support
|
| Room no.A5,
5th floor,
Health Science block,
Saveetha college of Physiotherapy,
Saveetha nagar,
Thandalam,
Kancheepuram,
Tamil Nadu- 602105
|
|
|
Primary Sponsor
|
| Name |
Prasanna Kumar R |
| Address |
Room no.A5,
5th floor,
Health Science block,
Saveetha college of Physiotherapy,
Saveetha nagar,
Thandalam,
Kancheepuram,
Tamil Nadu- 602105 |
| Type of Sponsor |
Other [Self] |
|
|
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 K Kotteeswaran |
Saveetha Hospital |
Room No. A5,
5th floor,
Health Science block,
Saveetha college of Physiotherapy,
Saveetha nagar,
Thandalam,
Kancheepuram,
Tamil Nadu 602501 Kancheepuram TAMIL NADU |
9894286700
k.kotteeswaran@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL SCIENTIFIC REVIEW BOARD |
Approved |
|
|
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 |
| Intervention |
Dynamic Joint Position Sense Exercises |
One leg balance
Blind advanced one leg balance
Cross body leg swing
Toe walking
Duration
6 weeks
3 days a week
10-15 reps
3 sets |
| Comparator Agent |
Static Joint Proprioceptive Exercises |
Pelvic bridging
Unilateral pelvic bridging
Mini squat
Single limb mini squat
Duration
6 weeks
3 days a week
10-15 reps
3 sets |
|
|
Inclusion Criteria
|
| Age From |
45.00 Year(s) |
| Age To |
78.00 Year(s) |
| Gender |
Both |
| Details |
primary unilateral osteoarthritis of knee
45 to 78 yrs age group
both male and female |
|
| ExclusionCriteria |
| Details |
Patients with complaints in one or more joint Polyarthritis
Presence of rheumatoid arthritis or other systemic inflammatory arthropathies
Knee arthroplasty surgery case
Intraarticular corticosteroid injection into either knee within the previous 3 months |
|
|
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, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Range of motion |
6 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Error Angle |
6 weeks |
|
|
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
|
Phase 2 |
|
Date of First Enrollment (India)
|
25/02/2025 |
| 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="1" Days="15" |
|
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
|
Osteoarthritis (OA) is a common, all-encompassing illness that mostly
affects the knee. Osteoarthritis
(OA) is a multifactorial disease that progresses over time and causes joint
constriction and loss of articular cartilage in addition to pain, functional
impairment, and physical disability, all of which significantly lower quality
of life. In addition to pain, knee OA patients also
experience muscle weakness, instability, exhaustion, and stiffness in morning.
Dehydration and the deterioration of intraarticular and periarticular
structures are pathophysiological alterations associated with osteoarthritis
(OA). This, in turn, induces mechanoreceptor distraction, which results in a
reduction in both static and dynamic kinaesthetic sensibility. Since limitations of stability, postural control, and knee
proprioception are important variables that can greatly contribute to
impairment, disability, and falls in people with KOA It has been demonstrated
that using manual interventions, exercise therapy, and electrotherapy alone or
in combination can improve proprioception and balance in physiotherapy
treatments. Therefore, it may be necessary to use specific strategies, such as
proprioceptive training, to tailor the therapeutic program for patients with
osteoarthritis. Recent research indicates
that proprioceptive training enhances muscle strength, balance, static and
dynamic posture, and everyday function. The need for this study is to identify the
research gap in order to find how dynamic JPS and static JPS exercise helps to
improve balance and joint position sense in unilateral knee osteoarthritis. |