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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03498833
Recruitment Status : Completed
First Posted : April 17, 2018
Last Update Posted : March 7, 2019
Sponsor:
Information provided by (Responsible Party):
Asir John Samuel, Maharishi Markendeswar University (Deemed to be University)

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.


Condition or disease Intervention/treatment Phase
Osteo Arthritis Knee Other: Test-retest reliability testing Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 52 participants
Intervention Model: Single Group Assignment
Intervention Model Description: 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.
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Comprehensive Knee Osteoarthritis Index (CKOAI): Scale Development, Validation and Reliability Testing
Actual Study Start Date : April 17, 2018
Actual Primary Completion Date : February 12, 2019
Actual Study Completion Date : February 13, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteoarthritis

Arm Intervention/treatment
Test-retest reliability testing
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
Set of patient reported outcome measures




Primary Outcome Measures :
  1. Change in Comprehensive Knee Osteoarthritis Index [ Time Frame: two occasions within two weeks to establish test retest reliability ]
    Set of patient reported outcome measures



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   40 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03498833


Locations
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India
Maharishi Markandeshwar Institute of physiotherapy and Rehabilitation
Ambala, Haryana, India, 133207
Sponsors and Collaborators
Maharishi Markendeswar University (Deemed to be University)
Investigators
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Study Director: Kanimozhi D Narkeesh, PhD Maharishi Markandeshwar Institute of physiotherapy and Rehabilitation

Additional Information:
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Responsible Party: Asir John Samuel, Associate Professor and Research Scholar, Maharishi Markendeswar University (Deemed to be University)
ClinicalTrials.gov Identifier: NCT03498833    
Other Study ID Numbers: MMU/IEC/1021
U1111-1211-8513 ( Other Identifier: Universal Trial Number )
L-78484/2018 ( Registry Identifier: Copyright Office (Government of India) )
First Posted: April 17, 2018    Key Record Dates
Last Update Posted: March 7, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Individual participant data will not be shared with other researchers. We are planned to publish the results in journal.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Asir John Samuel, Maharishi Markendeswar University (Deemed to be University):
domains
item development
osteoarthritis
scale formulation
test retest reliability
Additional relevant MeSH terms:
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Osteoarthritis
Osteoarthritis, Knee
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases