| CTRI Number |
CTRI/2024/10/074964 [Registered on: 09/10/2024] Trial Registered Prospectively |
| Last Modified On: |
07/10/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Biphasic Observational Study |
| Study Design |
Other |
|
Public Title of Study
|
Establishing a Validated Gujarati Kujala Patellofemoral Score for Patients with Anterior Knee Pain |
|
Scientific Title of Study
|
Translation, cross-cultural adaptation and
establishment of psychometric properties of
the Gujarati version of Kujala
patellofemoral score in subjects with
anterior knee pain |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Vidhi Desai |
| Designation |
Post Graduate Student |
| Affiliation |
SPB Physiotherapy College |
| Address |
OPD 1 and 4, department of musculoskeletal physiotherapy,Ugat bhesan road, Morabhagal,rander road, Surat
Ugat bhesan road, Morabhagal,rander road, Surat
Surat
GUJARAT
395005
India |
| Phone |
7226999139 |
| Fax |
|
| Email |
vidhibdesai55@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Neeti Mishra |
| Designation |
Professor |
| Affiliation |
SPB Physiotherapy College |
| Address |
OPD 1 and 4, department of musculoskeletal physiotherapy,Ugat bhesan road, Morabhagal,rander road, Surat
Surat
GUJARAT
395005
India |
| Phone |
9879697384 |
| Fax |
|
| Email |
dr.neetimishra@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Vidhi Desai |
| Designation |
Post Graduate Student |
| Affiliation |
SPB Physiotherapy College |
| Address |
OPD 1 and 4, department of musculoskeletal physiotherapy,Ugat bhesan road, Morabhagal,rander road, Surat
Surat
GUJARAT
395005
India |
| Phone |
7226999139 |
| Fax |
|
| Email |
vidhibdesai55@gmail.com |
|
|
Source of Monetary or Material Support
|
| SPB Physiotherapy College,OPD 1 and 4, department of musculoskeletal physiotherapy,Ugat bhesan road, Morabhagal,rander road, Surat, Gujarat, India, 395005 |
|
|
Primary Sponsor
|
| Name |
SPB Physiotherapy College |
| Address |
OPD 1 and 4, department of musculoskeletal physiotherapy,Ugat bhesan road, Morabhagal,rander road, Surat, Gujarat, India, 395005 |
| Type of Sponsor |
Research institution |
|
|
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 Vidhi Desai |
SPB Physiotherapy College |
OPD 1 and 4, department of musculoskeletal physiotherapy,Ugat bhesan road, Morabhagal,rander road, Surat
Surat
GUJARAT |
07226999139
vidhibdesai55@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| InstitutionalEthicsCommittee(IEC) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M222||Patellofemoral disorders, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients, who can read, write and speak Gujarati language and English language.
Patients having unilateral/ bilateral anterior knee pain while any 3 of activities like while ascending/descending stairs, while squatting, while running, while cycling, while sitting with knees flexed for a prolonged duration.
Patients with a positive Clark‟s test.
|
|
| ExclusionCriteria |
| Details |
Patients with any previous knee injuries.
Patients who have undergone any knee surgeries previously.
Patients with tibiofemoral arthritis.
Patients diagnosed with any knee pathology like patellar tendinopathy.
Patients with history of patellar dislocation or subluxation.
Patients with communication problem.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| KUJALA PATELLOFEMORAL SCORE |
on the same day
after 48 hours |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
LYSHOLM KNEE SCORE
SF-12
WOMAC |
on the same day
after 48 hours |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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)
|
18/10/2024 |
| 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="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
|
Translation, cross-cultural adaptation and establishment of psychometric properties of the Gujarati version of Kujala patellofemoral score in subjects with anterior knee pain Ethical clearance will be obtained from the institutional ethics committee, adhering to the Declaration of Helsinki. Subjects with anterior knee pain, diagnosed by an orthopaedic surgeon, will be included based on specific criteria. All participants will provide written informed consent and demographic information. Phase 1: Translation and Cross-Cultural Adaptation The Kujala Patellofemoral Score (KPS) will be translated into Gujarati using a methodical process. Two translations will be performed independently by an orthopaedic surgeon and a professional translator. These will be synthesized into a consensus version, which will then be back-translated into English by two Gujarati-speaking translators. Both the translations and back-translations will be reviewed in consensus meetings. The nearly final Gujarati version will be pre-tested with 30 subjects experiencing anterior knee pain to ensure all items are clear and comprehensible. Phase 2: Assessment of Psychometric Properties - Reliability: The KPS-G’s test-retest reliability will be evaluated with 30 subjects who will complete the questionnaire twice, 48 hours apart.
- Face Validity: Assessed by asking patients if they find the scale relevant to their condition, with responses recorded as "yes" or "no."
- Content Validity: Evaluated by experts using a Likert scale (0-6) to assess content equivalence, relevance, and representativeness.
- Concurrent Validity: Measured by comparing the KPS-G with the WOMAC score.
- Construct Validity:
- Convergent Validity: Assessed by comparing the KPS-G with the Lysholm knee score.
- Divergent Validity: Assessed by comparing the KPS-G with the SF-12 questionnaire.
|