| CTRI Number |
CTRI/2025/07/091020 [Registered on: 16/07/2025] Trial Registered Prospectively |
| Last Modified On: |
16/07/2025 |
| 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
|
Improving knee health with vibration therapy and resistance exercises. |
|
Scientific Title of Study
|
Effect of Vibrotherapy in addition to Resistance training exercises on pain, balance, proprioception and disability in patients with 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 |
DIKSHITA KABBA |
| Designation |
PG student |
| Affiliation |
Maharishi Markandeshwar Institute of Physiotherapy and Rehabilitation |
| Address |
Room No.2 Ground floor, Department of Physiotherapy, Maharishi Markandeshwar Institute of Physiotherapy and Rehabilitation, Maharishi Markandeshwar (Deemed to be University), Mullana-Ambala, Haryana
Ambala
HARYANA
133207
India |
| Phone |
8609251595 |
| Fax |
|
| Email |
kdikshita12150@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Manu Goyal |
| Designation |
Principal and Professor |
| Affiliation |
Maharishi Markandeshwar Institute of Physiotherapy and Rehabilitation |
| Address |
Room No. 7 Ground floor, Department of Physiotherapy, Maharishi Markandeshwar Institute of Physiotherapy and Rehabilitation, Maharishi Markandeshwar (Deemed to be University), Mullana-Ambala, Haryana
Ambala
HARYANA
133207
India |
| Phone |
8307715308 |
| Fax |
|
| Email |
manu.goyal@mmumullana.org |
|
Details of Contact Person
Public Query
|
| Name |
Dr Manu Goyal |
| Designation |
Principal and Professor |
| Affiliation |
Maharishi Markandeshwar Institute of Physiotherapy and Rehabilitation |
| Address |
Room No. 7 Ground floor, Department of Physiotherapy, Maharishi Markandeshwar Institute of Physiotherapy and Rehabilitation, Maharishi Markandeshwar (Deemed to be University), Mullana-Ambala, Haryana
Ambala
HARYANA
133207
India |
| Phone |
8307715308 |
| Fax |
|
| Email |
manu.goyal@mmumullana.org |
|
|
Source of Monetary or Material Support
|
| Dikshita Kabba
Room No.2 Groundfloor, Department of Physiotherapy, Maharishi Markandeshwar Institute of Physiotherapy and Rehabilitation, Maharishi Markandeshwar (Deemed to be University), Mullana-Ambala, Haryana, India (133207) |
|
|
Primary Sponsor
|
| Name |
Dikshita Kabba |
| Address |
Maharishi Markandeshwar Institute of Physiotherapy and Rehabilitation, Maharishi Markandeshwar (Deemed to be University), Mullana-Ambala, Haryana, India (133207) |
| 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 |
| Dikshita Kabba |
Maharishi Markandeshwar Superspeciality Hospital |
Room No.116, First floor, Department of Physiotherapy, Maharishi Markandeshwar Institute of Physiotherapy and Rehabilitation, Maharishi Markandeshwar (Deemed to be University), Mullana-Ambala, Haryana, India (133207)
Ambala
HARYANA |
8609251595
kdikshita12150@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee, Maharishi Markandeshwar Institute of Medical Sciences and Research, Mullana, Ambala, Communication of Decision of Ethics Committee |
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 |
Control group |
Participants will receive sham local joint vibration therapy applied to the medial and lateral joint lines using a biothesiometer. This intervention will be followed by a 10-minute session of static cycling to facilitate muscular warm-up. Subsequently, participants will perform a resistance training regimen consisting of the following exercises: knee extensions (3 sets of 10 repetitions), hip abductions (3 sets of 10 repetitions), and hamstring curls (3 sets of 10 repetitions). This combined intervention will be administered three times per week over a duration of four weeks.
|
| Intervention |
Experimental group |
Participants will receive local joint vibration therapy applied to the medial and lateral joint lines using a biothesiometer. This intervention will be followed by a 10-minute session of static cycling to facilitate muscular warm-up. Subsequently, participants will perform a resistance training regimen consisting of the following exercises: knee extensions (3 sets of 10 repetitions), hip abductions (3 sets of 10 repetitions), and hamstring curls (3 sets of 10 repetitions). This combined intervention will be administered three times per week over a duration of four weeks.
|
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Both male and female
Diagnosed with tibiofemoral knee OA
Grades 1,2 and 3 of knee OA according to Kellgren Lawrence Grading system
Persistent symptoms in both knees such as pain and stiffness for a period of at least 3
months
A minimum pain intensity score of more than 3 on Visual Analog Scale (VAS)
Patient ambulatory with no use of any assistive device
No any sensory disturbance |
|
| ExclusionCriteria |
| Details |
History of any trauma/injury in previous 6 months
Individuals having history of any previous surgery
Individuals suffering from central nervous system disease
History of DVT, aneurysms, stroke, epilepsy
Intellectual limitations and mental performance
Individuals suffering from any other musculoskeletal, neurological, cardiopulmonary
conditions.
Diabetes mellitus, cardiac or respiratory insufficiency, and inability to understand the
procedure |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Visual Analog Scale (VAS)
Comprehensive Knee Osteoarthritis Index (CKOAI)
Sensamove (balance and proprioception) |
At Baseline and at 4 weeks |
|
|
Secondary Outcome
|
|
|
Target Sample Size
|
Total Sample Size="26"
Sample Size from India="26"
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)
|
11/08/2025 |
| 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 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
|
Knee
osteoarthritis (OA) is a degenerative joint disease marked by cartilage
breakdown, synovial inflammation, bone sclerosis, and osteophyte formation.
These changes can damage sensory receptors, particularly mechanoreceptors,
leading to impaired proprioception. This impairment contributes to balance
deficits and increased fall risk. Purpose: The purpose of current study is to
determine the effect of local joint vibration therapy on pain, balance,
proprioception and disability in patients with Knee Osteoarthritis. Study design will be a Single blinded randomized sham
trial. Participants will be recruited on the basis of inclusion and exclusion
criteria. Subjects will be randomly allocated into two groups, group 1 and
group 2 through computer based random allocation techniques. Group 1 will
receive vibration therapy along with resistance training and group2 will
receive sham vibration therapy along with resistance training exercises. Pre
test and posttest assessment will be done by VAS, CKOAI, Sensamove. Data will be analysed using SPSS software
version 20. The findings from the study will help to improve clinical outcomes
by enhancing balance, proprioception, and overall functional ability and can
ultimately reduce disability and improve quality of life in patients with knee
OA.
|