NCT02514395

Brief Summary

Background: KOOS is a self -administered instrument which assesses the patient's opinion about the Knee associated problems. For now it is available in English \& various other languages \& is a complete instrument in itself. In India it has been translated in Hindi so far. However, each province in this country has a unique language. Maharashtra is the second largest state in India and Marathi is the regional language of the communication. Since KOOS is a self-report measure, its translation in this local language was thought to be necessary. This disease specific measure which is originally designed for English speaking region when employed to non-English population needed to be translated with unique method to achieve a normative equivalence and linguistic validation. Methods: After taking permission from KOOS web manager T1, T2, T12, B1 \& B2 versions were formatted according to the guidelines laid down by AAOS for cross cultural adaptation of health status measure. T12 version was sent for the field testing. Total 32 subjects who met the eligibility criteria were Included in this study. Results: Statistical analysis for reliability with test re-test method suggested Perfect correlation (r =1) between day 1 \& 2. A range of 0.83-0.54 co-relation co-efficient (r) demonstrated the validity of KOOS and its subscales when compared against the 8 different domains of SF-36. All this correlations were statistically highly significant. Sport and recreation subscale had many missing responses since many items in this subscale were not appropriate for the Maharashtrian cultural set-up. Participants additionally provided the information about other functional activities which were difficult to execute due to knee associated pain and disability. Conclusion: Marathi version of KOOS is proved to be a reliable \& valid measure. Future scope: this study demonstrate a need to undertake the cross cultural adaptation since a constant pattern of impairment revealed in the execution of daily activities such as sitting on the floor and attending certain yoga postures etc. Key words: linguistic validation, disease specific self-report, KOOS, Marathi translation, quality of life.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
32

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Sep 2012

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2012

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2013

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2013

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

July 6, 2015

Completed
28 days until next milestone

First Posted

Study publicly available on registry

August 3, 2015

Completed
Last Updated

November 27, 2023

Status Verified

November 1, 2023

Enrollment Period

10 months

First QC Date

July 6, 2015

Last Update Submit

November 21, 2023

Conditions

Keywords

linguistic validationKOOSMarathi translation

Outcome Measures

Primary Outcomes (1)

  • Knee Injury and Osteoarthritis Outcome Score (KOOS)

    It is a questionnaire designed to assess short and long-term patient-relevant outcomes following knee osteoarthritis or mechanical knee somatic dysfunction.

    2 days

Interventions

Final T12 version of KOOS was given to the participants by an assistant who was not involved with any prior procedure. At the same time SF- 36 v2\[32\] generic health measure was also handed over. Filled forms were collected by the same assistant. Next day participants were given another blank copy of Marathi KOOS T12 versions. Hence each participant filled three forms.

Eligibility Criteria

Age40 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Eligible subjects who the fulfilled the inclusion criteria were register for the study.

You may qualify if:

  • Subjects who were diagnosed for osteoarthritis of knee
  • who have not undergone any physical therapy treatment previously were considered eligible.

You may not qualify if:

  • )subjects who didn't give any informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
asso.prof.

Study Record Dates

First Submitted

July 6, 2015

First Posted

August 3, 2015

Study Start

September 1, 2012

Primary Completion

July 1, 2013

Study Completion

November 1, 2013

Last Updated

November 27, 2023

Record last verified: 2023-11