- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05239962
A Reliability And Validity Study Of The Urdu Version Of Spine Functional Index.
April 2, 2022 updated by: Riphah International University
Evaluation of Reliability and Validity of Urdu Version of Spine Functional Index
The Aim of the study is to translate Spine Functional Index scale into Urdu Language and to investigate the validity and reliability in Pakistan with the populace of Spinal disorders.
Also checks its co-relation with Neck disability Index and Roland-Morris Disability Questionnaire.
Study Overview
Status
Completed
Conditions
Detailed Description
As per the previous recommendations, the Spine Functional Index will be interpreted in urdu language and adapted culturally.
Participants will be selected by the convenience sampling technique based on pre-defined inclusion and exclusion criteria from a total of 220 participants with spinal Disorders.
To test the reliability of Urdu Version Of Spine Functional Index, Neck Disability Index and Roland-Morris Disability Questionnaire in the inter and intra-observer environment, two observers and an interim interval of 45 minutes between the first and second application fill out a questionnaire on the same day for the inter-observer assessment.
Observer-1 for the intra-observer evaluation will conduct a third evaluation after 7 days.
Using Statistical Package of Social Sciences version 24, data is entered and analyzed.
Cronbach Alpha Value is used to analyze center consistency.
The intraclass correlation coefficient is used to assess the reliability of the test-retest.
For content validity, criteria validity and responsiveness, the Urdu Version Of Spine Functional Index was assessed.
Study Type
Observational
Enrollment (Actual)
220
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Punjab
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Faisalabad, Punjab, Pakistan, 38000
- Ripah International University
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
The population will be of Spinal cord disorders like.
Lumbar or thoracic or Cervical or Multiple Areas pain
Description
Inclusion Criteria:
- The criteria for participation in this study were at least 18 years of age.
- The patient must be diagnosed with musculoskeletal disorder of the spine.
- The patient can be chronic and sub-acute and acute.
- The patient can be referred by a physician or physical therapist.
Exclusion Criteria:
- Lack of reading Urdu or reply to the survey questions were the criteria for exclusion.
- Infectious diseases and patient without spinal disorders were excluded.
- The patients with late surgery or systemic sickness which effects spine was excluded
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Ecologic or Community
- Time Perspectives: Cross-Sectional
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Spine Functional Index
Time Frame: 1st day
|
Spine Functional Index is a single page of 25 items with a three-point respond option.
The score of 25 items is summed and this score is then multiplied by four and deducted from 100 (0 % score = max disability or functional loss and 100 % score = no impairments or normal).
|
1st day
|
Roland-Morris Questionnaire
Time Frame: 1st day
|
Roland-Morris Questionnaire is a self-administered disability measure in which greater levels of disability are reflected by higher numbers on a 24-point scale.
|
1st day
|
Neck Disability Index
Time Frame: 1st day
|
Neck Disability Index contains total 50 scores.
5 marks for each statement.
If the response is missing then the score will not be conducted or included in total marks.
|
1st day
|
Oswestry Low Back Pain Index
Time Frame: 1st day
|
Oswestry Low Back Pain Index is an extremely important tool that researchers and disability evaluators use to measure a patient's permanent functional disability.
The test is considered the 'gold standard' of low back functional outcome tools.
A score of 0-20 reflects minimal disability, 21-40 moderate disability, 41-60 severe disability, 61-80 crippled, and 81-100 bed-bound.
|
1st day
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
May 30, 2021
Primary Completion (Actual)
March 1, 2022
Study Completion (Actual)
March 5, 2022
Study Registration Dates
First Submitted
February 4, 2022
First Submitted That Met QC Criteria
February 4, 2022
First Posted (Actual)
February 15, 2022
Study Record Updates
Last Update Posted (Actual)
April 5, 2022
Last Update Submitted That Met QC Criteria
April 2, 2022
Last Verified
April 1, 2022
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- REC/FSD/0289
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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