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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05431842
Other study ID # REC-FSD-00265
Secondary ID
Status Completed
Phase
First received
Last updated
Start date May 30, 2021
Est. completion date July 20, 2023

Study information

Verified date May 2024
Source Riphah International University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The aim of study is to translate and culturally adapt Functional Gait Assessment Scale into Urdu language and to investigate the reliability and validity in Pakistani Stroke patients. Also check its correlation with Berg Balance Scale and Barthel Index


Description:

The English version of the Functional Gait Assessment Scale will be translated and culturally adapted as per previous recommendation. In geriatric population, Urdu Version of Functional Gait Assessment Scale will distributed among 160 participants choose by convenience sampling technique based on pre-defined inclusion and exclusion criteria.To test inter and intra-observer reliability of the final Urdu Version of Functional Gait Assessment Scale, Barthel Index and Berg Balance Scale, questionnaire will be filled on the same day. Data will be entered and analyzed using Statistical Package of Social Sciences Version 24. Internal consistency will be analyzed with Cronbach alpha value. Test- retest reliability will be assessed for intra-class correlation coefficient. The Urdu Version of Functional Gait Assessment Scale was evaluated for content validity, construct validity, criterion validity and responsiveness.


Recruitment information / eligibility

Status Completed
Enrollment 160
Est. completion date July 20, 2023
Est. primary completion date July 15, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Age at least 18 years - Post stroke patients past 3 months - Both gender patients are included Exclusion Criteria: - Patient suffering from any neurological disorder - Patient suffering from any musculoskeletal disorder - Patients who are post stroke less than 3 months

Study Design


Related Conditions & MeSH terms


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 Functional Gait Assessment Scale Functional Gait Assessment Scale is used to evaluate the constructions of balance and gait in ambulatory stroke patients. Number of Test Items: 10 Scoring: Each item is scored on an ordinal scale from 0 - 3, with 0 = severe impairment, 1 = moderate impairment, 2 = mild impairment, 3 = normal ambulation, Thus, the highest score is 30/30. 1st day
Primary Barthel Index Barthel Index is use to assess the level of independence and autonomy of stroke patient in performing ADLs. It is a list of 10 elementary ADLs: feeding, grooming, bathing, dressing, bowel and bladder care, toilet use, ambulation, transfers, and stair climbing. The activities are rated through time taken and assistance used by patient. Score ranges from 0-100. 1st day
Primary Berg Balance Scale the berg balance scale is an objective assessment of balance performance based on 14 items common to daily activities. it is a 14 items scale that rate 0 (unable to perform) to 4 (normal performance) for each item. the total score is 56 points, high score higher balance ability 1st day
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