| CTRI Number |
CTRI/2024/10/075313 [Registered on: 15/10/2024] Trial Registered Prospectively |
| Last Modified On: |
08/10/2024 |
| 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
|
Virtual Reality-Based Exercises on symptom of Pain, joint position sense and Joint Functions in Osteoarthritis of knee |
|
Scientific Title of Study
|
Effectiveness of Immersive Virtual Reality Based Exercises on pain,Proprioception and Function in subjects with osteoarthritis of knee |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Vaheedha s |
| Designation |
PhD Scholar |
| Affiliation |
Saveetha College of Physiotherapy,Saveetha Institute of Medical and Technical Sciences |
| Address |
Saveetha college of Physiotherapy,
Saveetha Institute of Medical and Technical Sciences,Thandalam,
Chennai,
Kancheepuram TAMIL NADU 602105 India |
| Phone |
9030851129 |
| Fax |
|
| Email |
svaheedha123@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
kumaresan Abathysagayam |
| Designation |
Professor and PhD Guide |
| Affiliation |
Saveetha College of Physiotherapy |
| Address |
Saveetha College of Physiotherapy,Saveetha Institute of Medical and Technical Sciences,Thandalam,
Kancheepuram TAMIL NADU 602105 India |
| Phone |
7299934070 |
| Fax |
|
| Email |
kresh49@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Vaheedha s |
| Designation |
PhD Scholar |
| Affiliation |
Saveetha College of Physiotherapy,Saveetha Institute of Medical and Technical Sciences |
| Address |
Saveetha college of Physiotherapy,
Saveetha Institute of Medical and Technical Sciences,Thandalam,
Chennai,
Kancheepuram TAMIL NADU 602105 India |
| Phone |
9030851129 |
| Fax |
|
| Email |
svaheedha123@gmail.com |
|
|
Source of Monetary or Material Support
|
| Self funded study will be conducted in Apollo college of physiotherapy, Apollo Institute of Medical Sciences and Research, Chittoor, Andhra pradesh,India
517127
Apollo District Head Quarters Hospital, AIMSR,Chitoor,Andhrapradesh, India |
|
|
Primary Sponsor
|
| Name |
Vaheedha S |
| Address |
Apollo college of physiotherapy,
Apollo Institute of Medical Sciences and Research,
Chittoor,
Andhra pradesh,
India,
517127 |
| 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 |
| Vaheedha S |
Chittoor District Head Quarters Hospital, Apollo Institute of Medical Science and Research. |
Room no 31, Physio
OPD, Apollo Chittoor
District Head Quarters
Hospital, Apollo institute
of medical sciences and
research,
Chittoor-517001,
Andhra Pradesh, India
Chittoor
Chittoor ANDHRA PRADESH |
9030851129
svaheedha123@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee-Apollo Institute Of Medical Sciences and Research |
Approved |
|
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Regulatory Clearance Status from DCGI
|
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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 |
Conventional Exercises along with Laser |
Conventional exercises include single leg standing with eyes closed on the affected and non-affected limb for 10 seconds on a firm and soft surface, half step stance for 10 seconds, one legged balance for 10 seconds, marching, knee extensions with TheraBand, unilateral gluteal bridge, supine straight leg lifts, prone leg lifts with 3-5 repetitions 4 sets, in addition to receiving Laser Therapy three times per week for 6 weeks with low level laser power and treatment. In this research, TECH LASER, SS1000 is utilized with low-level laser therapy parameters: 808 nm Wavelength, 0.4 CM Length, 8 Joules/Point of Energy for each point over a 10-minute period totaling 128 Joules. The laser will be placed around the knee joint on eight points including the medial and lateral epicondyle of the tibia and femur, the medial and lateral knee joint gap, and the medial edge of the tendon of biceps femoris and semitendinosus muscle in the popliteal fossa.
|
| Intervention |
Virtual reality along conventional Exercises,Laser |
The experimental group will receive the interactive virtual reality game in addition to Conventional exercises,The VR used in the study is the Oculus Quest, Rewin Health and will be upgraded to Oculus Quest 2. The game includes Jerry and Jerrys Coastal Saga, where players stand on a virtual platform and move their lower limbs back and forth following pink arrows for guidance. A 5 minute warm up will be followed by 12 minutes of walking at their own pace and finished off with a 5-minute cool down. There are three levels (easy, medium, hard) for knee extension, hip flexion, and hip abduction exercises, with 5 to 25 repetitions in 4 sets. The blue sensor is placed at the shin bone of the tibia for knee extension and at the mid thigh for hip flexion |
|
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Inclusion Criteria
|
| Age From |
45.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1. Unilateral Knee joint involvement.
2. NPRS less than 7 Points
3.Based on 3 to 4 categories of KELLGREN AND LAWRENCE, having at least 6months of knee pain.
4.Both male and female subjects.
|
|
| ExclusionCriteria |
| Details |
1. Any Recurrent knee injury, such as Tendon or Ligament Tear
2. Patients history of traumatic injury and surgery of knee joint
3. Unstable health conditions like heart, lung conditions
4. Patients unable to walk independently
systemic and psychiatric illness
5. Open wounds any ulcers in the foot or skin
6. Patients with Deep sensation impairement. |
|
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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 and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.Joint Propriocpetion Test, 2.WOMAC,
3.NPRS |
4 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| 4.Range of Motion |
4 weeks |
|
|
Target Sample Size
|
Total Sample Size="64" Sample Size from India="64"
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)
|
22/10/2024 |
| 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="2" 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 - YES
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identification.
- What additional supporting information will be shared?
Response - Study Protocol Response - Statistical Analysis Plan
- Who will be able to view these files?
Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.
- For what types of analyses will this data be available?
Response - For individual participant data meta-analysis.
- By what mechanism will data be made available?
Response - Proposals should be directed to [svaheedha123@gmail.com].
- For how long will this data be available start date provided 01-10-2024 and end date provided 05-10-2025?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
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Brief Summary
|
INTRODUCTION: Knee osteoarthritis (OA) is one of the most common musculoskeletal disorders and represents a major cause of debilitation in affected individuals, The age of respondents ranged from 18–80 years, with a mean of 35 ± 13.11 (Omar W. Athomali et.al, 2005) In people aged was Approximately to worldwide (3.6% of population have knee osteoarthritis) 36,000/Million, Knee OA is the most common form of arthritis associated with functional impairment in middle aged and elder people, There is potential association between impaired knee proprioception and pathological changes during early stages of knee OA (Bennell KL et al 2003),There are several therapies including the recent technological interventions such as AI and VR for OA. VR Is a novel technology defined as “the use of interactive simulations created with computer hardware and software to present users with opportunities to engage in environment that appear to be a feel a similar to real-world objects and events, The contribution of vision and proprioception to retrieving information about own body location and movement at different stages of remembering i.e., encoding, storage and recall phases. Understanding this complex relationship is crucial for development of technologies that facilitate human navigation and to inform motor rehabilitation programme in patients with Knee OA (KOA), weakening and damage of the knee muscles, tendons, ligaments, and articular capsule is related to body’s proprioception decreases (Relph and Herrington, 2015). The weakening and damage of proprioceptors make patients’ pain and perception abnormal could lead to the severe consequence of KOA (Bennell et al., 2003). Weak patients with poor proprioceptors have limited joint functional ability (van der Esch et al., 2007) The repeated proprioceptive training with functional elements increased cumulative neural inputs to the central nervous system via mechanoreceptors and proprioceptors in the joint capsules, ligaments, muscles, tendons, and skin. NEED FOR THE STUDY: During each stage of osteoarthritis knee, many pathological changes take place the destruction of smooth cartilage that covers the ends of bones, reduction of joint space, and formation of new bone called osteophytes taking place on joint margins. All these changes lead to weakness of muscles around the joint, joint pain, Proprioceptive deficits, decreased physical functional activities of individuals, balance disturbances, etc. The study on virtual reality-based exercises in osteoarthritis (OA) knee treatment is crucial to address the growing need for innovative and patient-centric approaches in healthcare. OBJECTIVES Ø To find the effectiveness of immersive virtual reality-based exercises on physical function in subjects with osteoarthritis of the knee. Ø To find the effectiveness of immersive virtual reality-based exercises on the range of motion in subjects with osteoarthritis of knee. Ø To find the effectiveness of immersive virtual reality-based exercises in measuring the Pain in subjects with osteoarthritis of the knee. Methodology: A total of 64 patients will be Recruited with unilateral osteoarthritis of knee based on selection criteria. Informed Consent and information sheet will be explained on obtained from all participants with their voluntary consent. Included participants will be The pre-participation evaluation form such as range of motion, numerical pain rating scale, womac questionarie, joint proprioception test after completion of the pre-test participants will be allocated into two groups by the concealed envelope method. Experimental group will be receiving virtual reality-based exercises along with conventional exercises, Laser and Control group both groups will be treated for 4 weeks 5 repetitions of 4 weeks Stastical analysis: Sample size calculated for 80% Population Proportion, 95% Confidence Interval, and 9% Margin Error for both experimental and control group samples will be allocated through concealed envelop as 32 in each group. Stastical analysis will be performed using Mann-Whitney U test for between- groups Comparison and Wilcoxon Test for within- groups comparisons Excepted outcomes: The primary excepted outcomes of the study include significant improvements in pain, functional outcome, proprioception, range of motion. Additionally, enhanced functional activity and proprioception post intervention is anticipated. |