NCT05997797

Brief Summary

This study is designed to translate and validate the FAAM questionnaire to the Urdu language, to interpret its psychometric properties, and to determine the reliability of scores obtained from the population of Pakistan. The translated version of the gold standard tool will be used by the local population as well as Urdu-speaking immigrants across the globe to better understand and report the severity of their symptoms. Hence, to improve quality of life across cultures, there is a need of standard outcome measures in Urdu language.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
175

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jul 2022

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 2, 2022

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 7, 2022

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 15, 2022

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

August 1, 2023

Completed
17 days until next milestone

First Posted

Study publicly available on registry

August 18, 2023

Completed
Last Updated

August 18, 2023

Status Verified

August 1, 2023

Enrollment Period

2 months

First QC Date

August 1, 2023

Last Update Submit

August 11, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • FAAM-U

    The FAAM is made out of two subscales including ADL and Sports subscales that have a complete score of 84 and 32, individually. Also, toward the finish of the structure, patients were approached to rate the current degree of function with a 4-point Likert scale

    72 Hours

Study Arms (1)

Single Group

A total of 175 patients with a range of foot or ankle problems were included for the review. Informed consent was taken from the review members in written form. They all finished the Urdu version of FAAM in the test session. With a time, span of 3 days after the primary recording, a total of the 175 patients whose conditions were relied upon to stay stable were approached to complete the forms again in the retest meeting; no treatment was given during this time-frame. The FAAM is made out of two subscales including ADL and Sports subscales that have a complete score of 84 and 32, individually. Also, toward the finish of the structure, patients were approached to rate the current degree of function with a 4-point Likert scale. Patients evaluated everything as indicated by the trouble they go over with each undertaking on account of their foot or ankle condition. After assortment, information was saved in a safe spot to keep away from any dispositions.

Other: FAAM

Interventions

FAAMOTHER

The FAAM is made out of two subscales including ADL and Sports subscales that have a complete score of 84 and 32, individually

Single Group

Eligibility Criteria

Age16 Years - 44 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

With a time, span of 3 days after the primary recording, a total of the 175 patients whose conditions were relied upon to stay stable were approached to complete the forms again in the retest meeting; no treatment was given during this time-frame.

You may qualify if:

  • Ankle and foot disorders, referred by a general physician or surgeon,
  • Conscious
  • Ambulatory
  • Able to write and read Urdu language

You may not qualify if:

  • inflammatory disease
  • vascular diseases
  • neural diseases
  • cancer

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The University of Lahore

Lahore, Punjab Province, 54000, Pakistan

Location

Related Publications (31)

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MeSH Terms

Conditions

Foot InjuriesAnkle Injuries

Condition Hierarchy (Ancestors)

Leg InjuriesWounds and Injuries

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 1, 2023

First Posted

August 18, 2023

Study Start

July 2, 2022

Primary Completion

September 7, 2022

Study Completion

November 15, 2022

Last Updated

August 18, 2023

Record last verified: 2023-08

Locations