| CTRI Number |
CTRI/2022/11/047670 [Registered on: 25/11/2022] Trial Registered Prospectively |
| Last Modified On: |
25/11/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Comparison of quadriceps muscle strength and balance in individuals with or without knee hyperextension |
|
Scientific Title of Study
|
Correlation between strength and balance of quadriceps muscles in healthy individuals versus individuals with genu recurvatum A Cross-Sectional Study |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Isha Upadhyay |
| Designation |
MPT Student |
| Affiliation |
Maharishi Markandeshwar Institute of Physiotherapy and Rehabilitation |
| Address |
Maharishi Markandeshwar Institute of Physiotherapy and Rehabilitation, Maharishi Markandeshwar deemed to be university Mullana, Ambala
Hostel no.07,Maharishi Markandeshwar Institute of Physiotherapy and Rehabilitation, Maharishi Markandeshwar deemed to be university Mullana, Ambala
Ambala
HARYANA
133207
India |
| Phone |
06350594410 |
| Fax |
|
| Email |
uupadhyayisha951@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Aksh Chahal |
| Designation |
Professor |
| Affiliation |
Maharishi Markandeshwar Institute of Physiotherapy and Rehabilitation |
| Address |
Maharishi Markandeshwar Institute of Physiotherapy and Rehabilitation, Maharishi Markandeshwar deemed to be university Mullana, Ambala
Maharishi Markandeshwar Institute of Physiotherapy and Rehabilitation, Maharishi Markandeshwar deemed to be university Mullana, Ambala
Ambala
HARYANA
133207
India |
| Phone |
9711774174 |
| Fax |
|
| Email |
prof.aksh_chahal@mmumullana.org |
|
Details of Contact Person
Public Query
|
| Name |
Aksh Chahal |
| Designation |
Professor |
| Affiliation |
Maharishi Markandeshwar Institute of Physiotherapy and Rehabilitation |
| Address |
Maharishi Markandeshwar Institute of Physiotherapy and Rehabilitation, Maharishi Markandeshwar deemed to be university Mullana, Ambala
Maharishi Markandeshwar Institute of Physiotherapy and Rehabilitation, Maharishi Markandeshwar deemed to be university Mullana, Ambala
Ambala
HARYANA
133207
India |
| Phone |
9711774174 |
| Fax |
|
| Email |
prof.aksh_chahal@mmumullana.org |
|
|
Source of Monetary or Material Support
|
| Maharishi Markandeshwar Institute of Physiotherapy and Rehabilitation, Maharishi Markandeshwar deemed to be university, Mullana, Ambala |
|
|
Primary Sponsor
|
| Name |
ISHA UPADHYAY |
| Address |
Maharishi Markandeshwar Institute of Physiotherapy and Rehabilitation, Maharishi Markandeshwar deemed to be university, Mullana, Ambala |
| 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 |
| ISHA UPADHYAY |
MMIPR Sports Lab |
MAHARISHI MARKANDESHWAR INSTITUTE OF PHYSIOTHERPY AND REHABILITATION, MAHARISHI MARKANDESHWAR DEEMED TO BE UNIVERSITY, MULLANA
Ambala
HARYANA |
6350594410
uupadhyayisha951@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical committee Maharishi M |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: Q798||Other congenital malformations ofmusculoskeletal system, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
25.00 Year(s) |
| Gender |
Both |
| Details |
1. Age group 18 to 25 years
2. Both Male and female
3. Quadriceps MMT more than 3
4. Participant able to walk independently
without external aids
|
|
| ExclusionCriteria |
| Details |
1. Impaired sensation
2. Previous history of knee surgeries
3. Pain in knee extension
4. Recent injuries or acute injuries of lower
limb
5. Pregnancy
6. Oedema and skin disorders to lower limbs
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Isokinetic dynamometer
Y-balance test
|
Baseline
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Goniometer |
Baseline |
|
|
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
|
N/A |
|
Date of First Enrollment (India)
|
25/11/2022 |
| 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="11"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
"Correlation between strength and balance of quadriceps muscles in healthy individuals versus individuals with genu recurvatum: A cross-sectional Study" ABSTRACT BACKGROUND: Genu recurvatum is characterized by hyperextension of knee or back knee. It leads to disability in quadriceps muscle strength and balance of individuals. Maintaining muscular strength and improved balance make it easier to do daily activities and prevent many conditions. There had never been any evidence of an interconnection between strength and balance in individuals with genu recurvatum. PURPOSE OF THE STUDY: Quadriceps muscle strength and balance are compromised following recurvatum. As the study aims to find correlation between strength and balance between healthy individuals versus individuals with genu recurvatum. The results obtained from the proposed study can lead to development of strategies focusing on improving the same. STUDY DESIGN: Cross-sectional study METHODOLOGY: Based on inclusion criteria 64 number of subjects will be taken, they will examine for the following outcomes 1) Isokinetic dynamometer 2) Y Balance test 3) Goniometry DISCUSSION: Quadriceps muscle weakness is one of the factors that can cause genu recurvatum. The proposed study will compare strength and balance of quadriceps muscle in healthy individuals versus individuals with genu recurvatum. The study will correlate and focus on improvement of these factors. KEYWORDS: Balance, Muscle, Muscular strength, Knee hyperextension ETHICAL CLEARANCE: Ethical approval will be obtained from Institutional Ethical Committee of Maharishi Markandeshwar Institute of Medical Sciences and Technology, Mullana, Ambala, Haryana and will be done in accordance with Helsinki Declaration revised in 2013 and National Ethical Guidelines for Biomedical Research involving Human Participants, 2017 METHODOLOGY: | INCLUSION CRITERIA | EXCLUSION CRITERIA | | o Age group 18 to 25 years o Male and female o All the participants should be able to walk independently without any external aids o Individual muscle testing for quadriceps muscle should be more than grade 3 | o Impaired sensation o Previous history of knee surgeries o Pain in knee extension o Recent injuries or acute injuries o Pregnancy o Oedema and skin disorders to lower limbs |
PROCEDURE:
• Ethical clearance • Screening of subjects according to inclusion/exclusion criteria • Informed consent and pre-assessment will be explained and performed • Outcomes will be measured • Data analysis • Results |