Comprehensive Knee Osteoarthritis Index (CKOAI): Scale Development, Validation and Reliability Testing

NCT03498833 | Completed

• 3 other identifiers: MMU/IEC/1021U1111-1211-8513L-78484/2018
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

Brief Summary

Background: Symptoms, balance, mobility, activities of daily life (ADL) and quality of life (QoL) are to be considered in rehabilitation of the individuals with knee osteoarthritis (IKOA). There are several scales to evaluate subjective perceptions and individual components in patients with osteoarthritis (OA). Till date, no scale is available to measure the combined balance, mobility, ADL and QoL in PKOA. Objectives: The objectives of the study are to develop a combined measure of symptoms, balance, mobility, ADL and QoL in PKOA, as comprehensive knee osteoarthritis index (CKOAI) and to validate the scale for its content, reliability and minimum detectable change (MDC) Methods: The study consists of a three stages. First stage is the scale (CKOI) item development and validation. This includes domain and item generating through systematic literature search to extract items related symptoms, balance, mobility, ADL and QoL in IKOA based on the International Classification of Functioning, Disability and Health (ICF) and through structured interviews. During scale validation, an expert panel will review the generated domains and items by Delphi Method, which will undergo revision and pilot testing. Based on the responsiveness of pilot testing will be revised finally. Second stage is to test re-test reliability. The third stage is to report the standard error of measurement (SEM) and minimal detectable change (MDC). Data analysis: All the domains and items in CKOAI will undergo reliability and criterion-related validity. Minimum 50 IKOA will be evaluated with the scale on two occasions within two weeks to establish test retest reliability. Cronbach's alpha for internal consistency and Intra class correlation coefficient for test retest reliability will be used to determine the degree of consistency of items in the scale. MDC will be calculated using the formulae, SEM = SD x √ (1-reliability) and MDC95 = √2 x (1.9) x (SEM). Significant level will be set at p value less than 0.05 (p \< 0.05) to minimize the type-I error.

Conditions

Osteo Arthritis Knee

Keywords

domains; item development; osteoarthritis; scale formulation; test retest reliability

Outcome Measures

Primary Outcomes (1)

• Change in Comprehensive Knee Osteoarthritis Index

  Set of patient reported outcome measures

  two occasions within two weeks to establish test retest reliability

Study Arms (1)

Test-retest reliability testing

OTHER

Minimum 50 IKOA will be evaluated with the scale on two occasions within two weeks to establish test retest reliability.

Other: Test-retest reliability testing

Interventions

Test-retest reliability testing OTHER

Set of patient reported outcome measures

Test-retest reliability testing

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Individuals with osteoarthritic changes of grade 1 and greater on knee radiograph (Kellgren and Lawrence)
• Individuals with unilateral or bilateral knee osteoarthritis
• Both male and female
• Individuals who able to understand simple command
• Individuals who are willing to participate

You may not qualify if:

• History of hip and knee replacement surgery
• History of knee arthroscopic surgery within 6 months
• Any neurologic and musculoskeletal condition which affect their movement or balance
• Comorbidities such as cancer or cardiovascular disease

Sponsors & Collaborators

• Maharishi Markendeswar University (Deemed to be University): lead

Study Sites (1)

Maharishi Markandeshwar Institute of physiotherapy and Rehabilitation

Ambāla, Haryana, 133207, India

Location

MeSH Terms

Conditions

Osteoarthritis

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Officials

• Kanimozhi D Narkeesh, PhD

  Maharishi Markandeshwar Institute of physiotherapy and Rehabilitation

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor and Research Scholar

Model Details: All the domains and items in CKOAI will undergo reliability testing. Minimum 50 IKOA will be evaluated with the scale on two occasions within two weeks to establish test retest reliability. Cronbach's alpha for internal consistency and Intra class correlation coefficient for test retest reliability will be used to determine the degree of consistency of items in the scale. MDC will be calculated using the formulae, SEM = SD x √ (1-reliability) and MDC95 = √2 x (1.9) x (SEM). Significant level will be set at p value less than 0.05 (p \< 0.05) to minimize the type-I error.

Study Record Dates

• First Submitted: April 5, 2018
• First Posted: April 17, 2018
• Study Start: April 17, 2018
• Primary Completion: February 12, 2019
• Study Completion: February 13, 2019
• Last Updated: March 7, 2019

Record last verified: 2019-03

Data Sharing

• IPD Sharing: Will not share

Locations

IN (1)