A Reliability And Validity Study Of The Urdu Version Of Spine Functional Index.

Spinal Deformity Clinical Trial

Official title:

Evaluation of Reliability and Validity of Urdu Version of Spine Functional Index

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05239962
• Other study ID #: REC/FSD/0289
• Status: Completed
• Start date: May 30, 2021
• Est. completion date: March 5, 2022

Study information

• Verified date: April 2022
• Source: Riphah International University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 220
• Est. completion date: March 5, 2022
• Est. primary completion date: March 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Congenital Abnormalities
• Spinal Deformity

Locations

Country	Name	City	State
Pakistan	Ripah International University	Faisalabad	Punjab

Sponsors (1)

Lead Sponsor	Collaborator
Riphah International University

Country where clinical trial is conducted

Pakistan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Spine Functional Index	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
Primary	Roland-Morris Questionnaire	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
Primary	Neck Disability Index	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
Primary	Oswestry Low Back Pain Index	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