| CTRI Number |
CTRI/2025/02/081018 [Registered on: 20/02/2025] Trial Registered Prospectively |
| Last Modified On: |
11/02/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Other |
|
Public Title of Study
|
Impact of Strengthening exercises in arthritis of knee, focusing on balance and quality of life. |
|
Scientific Title of Study
|
Efficacy of Strengthening Intervention on Balance and Quality of Life in Patients with Knee Osteoarthritis Associated with Instability: A Case Series |
| Trial Acronym |
OA |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Eati Bavya Sri Sowmya |
| Designation |
Student |
| Affiliation |
GIMSR medical college, GITAM (Deemed to be university) |
| Address |
GITAM School of Physiotherapy,
4th Floor, GIMSR Medical college Building, GIMSR Campus, GITAM (Deemed to be University), Gandhinagar, Rushikonda, Visakhapatnam 530045,
Andhra Pradesh.
Visakhapatnam
ANDHRA PRADESH
530045
India |
| Phone |
9010728042 |
| Fax |
|
| Email |
eatibhavya03@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Eati Bavya Sri Sowmya |
| Designation |
Student |
| Affiliation |
GIMSR medical college, GITAM (Deemed to be university) |
| Address |
GITAM School of Physiotherapy,
4th Floor, GIMSR Medical college Building, GIMSR Campus, GITAM (Deemed to be University), Gandhinagar, Rushikonda, Visakhapatnam 530045,
Andhra Pradesh.
Visakhapatnam
ANDHRA PRADESH
530045
India |
| Phone |
9010728042 |
| Fax |
|
| Email |
eatibhavya03@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Gokarakonda Sree Vamsi |
| Designation |
Assistant professor |
| Affiliation |
GIMSR Medical College, GITAM (Deemed to be university) |
| Address |
GITAM School of Physiotherapy,
4th Floor, GIMSR Medical college Building, GIMSR Campus, GITAM (Deemed to be University), Gandhinagar, Rushikonda, Visakhapatnam 530045,
Andhra Pradesh.
Visakhapatnam
ANDHRA PRADESH
530045
India |
| Phone |
9010728042 |
| Fax |
|
| Email |
sgokarak@gitam.edu |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Eati Bavya Sri Sowmya |
| Address |
GITAM School of Physiotherapy,
4th Floor, GIMSR Medical college Building, GIMSR Campus, GITAM (Deemed to be University), Gandhinagar, Rushikonda, Visakhapatnam 530045,
Andhra Pradesh. |
| 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 |
| Eati Bavya Sri Sowmya |
GITAM Institute of Medical Science and Research |
Room number:01,department of physiotherapy, Gandhinagar, Rushikonda, Visakhapatnam.
Visakhapatnam
ANDHRA PRADESH |
9010728042
eatibhavya03@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| GITAM Institute of Medical Science and Research |
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 |
Nil |
Nil |
| Intervention |
Strength training, balance training and pain management. |
Cryotherapy, TENS Modality, static quadriceps, Heel slides, SLR, Hip against gravity movements, Heel Raise, Bodyweight Squats, Cycling, Stretching, Fatigue management, Awareness about the condition, Dietary changes, Weight management, Regular exercise, ROM Exercises, Open chain hip and knee strengthening with ankle weights, core exercises, Pelvic lift, sliding lunges, stepping lunges, step up, step down, chair stands, squats, Balance exercises, proprioception exercises, gait training, agility(Ramp up and down), plyometrics (according to the patient ability).
|
|
|
Inclusion Criteria
|
| Age From |
45.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1) Patients with Kellgren-Lawrence Grade II -III OA.
2) Ligament laxity, particularly in the anterior cruciate ligament (ACL) or medial collateral ligament (MCL).
3) Persistent knee instability and pain for at least 6 months.
4) Functional limitations such as difficulty in balance or walking, impacting daily activities.
|
|
| ExclusionCriteria |
| Details |
1)Patients with severe knee deformities or fractures.
2) Patients with recent knee surgeries or joint replacements (e.g., total knee replacement - TKR).
3) Active malignancies or significant trauma within the last year.
4) Use non-conservative interventions like corticosteroid injections or visco-supplementation within the past 3 months.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Western Ontario and McMaster Universities Osteoarthritis Index, Timed Up and Go Test, Beighton score |
3 points
At the day of enrollment
6th week
12th week
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Timed Up & Go Test |
3 points
At the day of enrollment
6th week
12th week |
|
|
Target Sample Size
|
Total Sample Size="6"
Sample Size from India="6"
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)
|
28/02/2025 |
| 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="1"
Months="0"
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
|
Osteoarthritis (OA) is a progressive degenerative condition that affects joint cartilage and leads to ligamentous instability, significantly impairing balance and functional mobility. The deterioration of intra-articular ligaments, particularly the anterior cruciate ligament (ACL) and medial collateral ligament (MCL), alters joint mechanics, contributing to instability and accelerating disease progression. Despite the growing recognition of ligament involvement in OA, there remains a gap in research addressing its impact on functional limitations and rehabilitation strategies. This study aims to evaluate the efficacy of physiotherapy interventions, specifically targeted strengthening exercises, in mitigating knee instability and improving functional outcomes in individuals with OA.
A case series study design has been employed to assess patients diagnosed with Stage 2 or Stage 3 knee OA, accompanied by ligament laxity, within the age group of 45–65 years. Participants undergo a structured three-phase rehabilitation program spanning three months, incorporating strengthening exercises, neuromuscular training, and proprioceptive balance training. The intervention follows a progressive approach, beginning with pain and inflammation management, followed by muscle activation, and culminating in advanced strengthening and functional retraining. A combination of in-person assessments and telerehabilitation sessions ensures continuous monitoring and patient adherence.
The study aims to determine whether offloading stress from affected ligaments while strengthening the surrounding musculature can improve knee stability, reduce pain, and enhance overall quality of life. Expected outcomes include improved balance, reduced functional limitations, and a slowed rate of disease progression. By bridging the gap between ligament instability and OA management, this research contributes to evidence-based physiotherapy practices, optimizing rehabilitation strategies for better patient outcomes. The findings will offer valuable insights into holistic OA treatment approaches, integrating ligament strengthening into conventional management to enhance long-term mobility and independence. |