| CTRI Number |
CTRI/2024/12/078800 [Registered on: 31/12/2024] Trial Registered Prospectively |
| Last Modified On: |
29/12/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Creating and Testing a New Device to Improve Knee Movement and Reduce Hamstrings muscle tightness in People with Limited Knee Mobility |
|
Scientific Title of Study
|
Designing and Testing a Novel Device for Improving Knee Range of Motion and Reducing Hamstring Muscle Tightness in Subjects with Reduced Knee Mobility: An Exploratory Study |
| 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 Himanshi Ruparelia PT |
| Designation |
Assistant Professor |
| Affiliation |
Marwadi University |
| Address |
Marwadi University
Morbi Road
Gauridad
Department of Physiotherapy
Marwadi University
Morbi Road
Gauridad
Rajkot
GUJARAT
360003
India |
| Phone |
9408322994 |
| Fax |
- |
| Email |
himanshi.ruparelia@marwadieducation.edu.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Himanshi Ruparelia PT |
| Designation |
Assistant Professor |
| Affiliation |
Marwadi University |
| Address |
Marwadi University
Morbi Road
Gauridad
Department of Physiotherapy
Marwadi University
Morbi Road
Gauridad
GUJARAT
360003
India |
| Phone |
9408322994 |
| Fax |
- |
| Email |
himanshi.ruparelia@marwadieducation.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Himanshi Ruparelia PT |
| Designation |
Assistant Professor |
| Affiliation |
Marwadi University |
| Address |
Marwadi University
Morbi Road
Gauridad
Department of Physiotherapy
Marwadi University
Morbi Road
Gauridad
GUJARAT
360003
India |
| Phone |
9408322994 |
| Fax |
- |
| Email |
himanshi.ruparelia@marwadieducation.edu.in |
|
|
Source of Monetary or Material Support
|
| SSIP - University
Marwadi University
Morbi Road
Gauridad
Rajkot Gujarat
360003 |
|
|
Primary Sponsor
|
| Name |
SSIP |
| Address |
Marwadi University
Morbi Road
Gauridad
Rajkot, Gujarat
360003 |
| Type of Sponsor |
Other [University startup fund] |
|
|
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 Himanshi Ruparelia PT |
Marwadi University |
Department of Physiotherapy
Marwadi University
Morbi Road
Gauridad
Rajkot
GUJARAT |
9408322994
himanshi.ruparelia@marwadieducation.edu.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Marwadi University Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M958||Other specified acquired deformities of musculoskeletal system, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
A novel device to improve knee mobility |
A device will be helpful in improving knee motion by providing passive movement
Movement in the pain free range will be given 10 repetition 3 sets using the device
stretching will be given using the device 3 repetition 30 seconds hold
|
| Comparator Agent |
Conventional Treatment |
Conventional treatment in the form of manual stretching and active and passive ROM exercise
Manual Active and Passive movement - 10 repetition 3 sets 5 days a week
Stretching - 3 repetition Manual static stretching for hamstring muscle 30 seconds hold |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patient having restriction in knee range of motion
due to diseases or surgery
Individuals having hamstring tightness |
|
| ExclusionCriteria |
| Details |
Patient suffering from any fixed deformity of hip, knee or ankle joint.
Spinal fractures and any other spinal complications
Patient having contraindication for mobilization
Patient having any neurological or myopathic condition.
Patient refuses to participate
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Range of motion using universal goniometer |
Range of motion using universal goniometer will be checked after 2 weeks of giving the treatment |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| SLR 90-90 for checking tightness of hamstring muscle |
Individual should be able to do almost complete knee extension with hip 90 degrees flexed will be check at the end of 2 weeks of the treatment |
|
|
Target Sample Size
|
Total Sample Size="70"
Sample Size from India="70"
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)
|
20/01/2025 |
| 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 mobility issues are highly prevalent among
individuals with musculoskeletal disorders such as knee osteoarthritis,
ligamentous injuries, and patellofemoral pain syndrome. These conditions often
lead to reduced knee range of motion (ROM) and increased hamstring tightness,
which can significantly impair daily activities and overall quality of life.
For instance, the global prevalence of knee osteoarthritis alone is estimated
to be around 22.9% in individuals aged 40 and above, highlighting the
widespread nature of knee mobility impairments .
•
The area of the limited mobility of knee lacks a
validated novel device which gives complete Range of motion to patient, leading
to a significant research gap. Research is needed to develop a novel device
which can provide complete knee mobility and to improve patient outcomes.
|