NCT05732636

Brief Summary

The goal of this Cross-cultural validation study is to Urdu translate and cross-cultural validation of Foot and Ankle Disability Index for the Patients with Chronic Ankle Instability. The main question it aims to answer was: • To Translate Foot and Ankle Disability Index in Urdu and to find out the Validity and Reliability for Patients with Chronic Ankle Instability. Data collection procedure would be, FADI Urdu version was introduced and the patients were asked to fill FADI Urdu version. The questionnaire was filled again by the same participants after one week to assess the test retest reliability. Questionnaire was conducted to have the best result. After the ethical approval, participants who meet the inclusion criteria and who were free from exclusion criteria were explained about the objectives of this study. Only those who gave consent were included in the study.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2023

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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 27, 2023

Completed
1 day until next milestone

Study Start

First participant enrolled

January 28, 2023

Completed
20 days until next milestone

First Posted

Study publicly available on registry

February 17, 2023

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2023

Completed
25 days until next milestone

Study Completion

Last participant's last visit for all outcomes

July 25, 2023

Completed
Last Updated

August 15, 2023

Status Verified

August 1, 2023

Enrollment Period

5 months

First QC Date

January 27, 2023

Last Update Submit

August 11, 2023

Conditions

Outcome Measures

Primary Outcomes (2)

  • Urdu version of Foot and Ankle Disability Index

    The Foot and Ankle Disability Index is a 34-item questionnaire divided into two subscales: the Foot and Ankle Disability Index and the Foot and Ankle Disability Index Sport. The FADI has 26 items, and the FADI Sport has 8. The FADI contains 4 pain related items and 22 activity related items. The FADI Sport contains 8 activity related items. It assesses more difficult tasks that are essential to sport. The FADI Sport is unique in that it is a population-specific subscale designed for athletes. It is designed to address this need by detecting deficits in higher functioning subjects.

    at Day 7

  • Foot and ankle ability measure (FAAM)

    The Foot and Ankle Ability Measure (FAAM) is a self-report outcome instrument developed to assess physical function for individuals with foot and ankle related impairments. It is a 29-item questionnaire divided into two subscales: the Foot and Ankle Ability Measure, 21-item Activities of Daily Living Subscale and the Foot and Ankle Ability Measure, 8-item Sports Subscale. Each item is scored on a 5-point Likert scale (4 to 0) from 'no difficulty at all' to 'unable to do'. Item score totals, which range from 0 to 84 for the ADL subscale and 0 to 32 for the Sports subscale, were transformed to percentage scores. Higher scores represent higher levels of function for each subscale, with 100% representing no dysfunction.

    at Day 7

Interventions

The whole protocol is divided into two stages: Urdu Translation and validation. Following steps were involved. 1. First version (Forward Translation): Forward translation from the English to Urdu by two bilingual translators (Version 1) 2. Second Version: Three experts compared the original FADI with urdu version of FADI. 3. Backward translation: Version 2 was translated Back in English by an independent translator. 4. Third Version: was finalized after tracking differences in forward and backward translation. 5. Final Version: of Urdu FADI was used on Chronic Ankle Instability patients. Foot and Ankle Disability Index(FADI) Urdu version was introduced and the patients were asked to fill FADI Urdu version. The questionnaire was filled again by the same participants after one week to assess the test retest reliability.

Eligibility Criteria

Age18 Years - 35 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Athletes at Pakistan Sports Board with Chronic Ankle Instability.

You may qualify if:

  • A history of ankle sprain with pain and/or limping for more than 1 day,
  • Chronic weakness, pain, or instability that they attributed to the initial injury
  • Giving way in the last 6 months.
  • Able to read Urdu Language

You may not qualify if:

  • Bilateral ankle instability
  • History of ankle fracture
  • Ankle injury within 3 months of participation
  • History of anterior cruciate ligament injury
  • History of balance disorder
  • Current participation in supervised physical rehabilitation.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pakistan sports board Lahore

Lahore, Punjab Province, 54000, Pakistan

Location

MeSH Terms

Conditions

Ankle Injuries

Condition Hierarchy (Ancestors)

Leg InjuriesWounds and Injuries

Study Officials

  • Saira Akbar Bodla, MS-SPT

    Riphah International University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Project Director

Study Record Dates

First Submitted

January 27, 2023

First Posted

February 17, 2023

Study Start

January 28, 2023

Primary Completion

June 30, 2023

Study Completion

July 25, 2023

Last Updated

August 15, 2023

Record last verified: 2023-08

Locations