- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05207592
Urdu Version of Foot and Ankle Disability Index: A Reliability and Validity Study
July 4, 2022 updated by: Riphah International University
Translation of Foot and Ankle Disability Index Into Local Urdu Language of Pakistan: A Reliability and Validity Study
The purpose of this research is to translate Foot and Ankle Disability Index in Urdu and determine the validity and reliability in patients with plantar fasciitis and correlate IT with Quality of Life Short Form-36 and the Visual Analog Scale.
Study Overview
Status
Completed
Conditions
Detailed Description
As per recommendation of the English Version of Foot and Ankle Disability Index will be translated and culturally adapted.
Foot and Ankle Disability Index along with its correlation scales will be distributed in the seventy plantar fasciitis population that will be selected according to inclusion exclusion criteria and through convenience sampling technique.
To check the inter and intra observer reliability of Foot and Ankle Disability Index, Short Form-36 to measure the quality of life and Visual Analog Scale to measure pain will be filled by participants.
Study Type
Observational
Enrollment (Actual)
70
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
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
The participant included in this study will be the patients of plantar fasciitis including both genders.
Description
Inclusion Criteria:
- Inability to achieve 20 degrees of active dorsiflexion
- Heel pain
- Mid foot pain
- Heal swelling
- Mid foot swelling
- Achilles' tendon tightness diagnosed on the base of Windlass test
Exclusion Criteria:
- Recent foot injury
- Fracture
- Infections
- Surgical procedures
- Tendon injury
- Hypermobility
- Neuromuscular disorders
- Impaired sensation
- Open sores
- Skin disease
- Active deep vein thrombosis or thrombophlebitis
- Bruises
- Varicose veins
- Burn Scars
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
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Foot and Ankle Disability Index
Time Frame: 1st day
|
The Foot and Ankle Disability Index is a 34-item questionnaire with two subscales: the Foot and Ankle Disability Index and the Foot and Ankle Disability Index Sport.
Foot and Ankle Disability Index has 26 items, whereas Foot and Ankle Disability Index Sport has 8.
The Foot and Ankle Disability Index includes four pain-related measures and twenty-two activity-related items.
The Foot and Ankle Disability Index Sport kit includes eight activities-related products.
It evaluates harder activities that are necessary in sports.
The Foot and Ankle Disability Index Sport is distinct in that it is a population-specific subscale created specifically for athletes.
|
1st day
|
36-Item Short Form Survey
Time Frame: 1st day
|
The 36-Item Short Form Survey is a popular, well-researched self-reported health assessment.
It is based on the Medical Outcomes Study, which consists of 36 questions covering eight areas of health:, Limitations in physical activities due to health issues, Limitations in social activities due to physical or mental issues, Restrictions in normal role activities due to physical health issues, Bodily discomfort, General mental health (psychological distress and well-being), Restrictions in regular role activities due to emotional issues, Vitality (energy and tiredness), General health perceptions.
The 36-Item Short Form Survey is frequently used to assess a person's or population's quality of life.
|
1st day
|
Visual Analogue Scale
Time Frame: 1st day
|
A Visual Analogue Scale is a measuring tool that attempts to quantify a trait or attitude that is thought to span throughout a range of values and cannot be easily quantified directly.
It is frequently used in epidemiologic and clinical research to assess the severity or frequency of different symptoms.
A patient's level of pain, for example, might range from none to high.
From the patient's point of view, this spectrum seems continuous; their pain does not appear to have distinct leaps, as a classification of none, mild, moderate, and severe would imply.
The Visual Analogue Scale was created to capture the concept of an underlying continuity.
|
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)
February 15, 2022
Study Completion (Actual)
February 28, 2022
Study Registration Dates
First Submitted
January 24, 2022
First Submitted That Met QC Criteria
January 24, 2022
First Posted (Actual)
January 26, 2022
Study Record Updates
Last Update Posted (Actual)
July 6, 2022
Last Update Submitted That Met QC Criteria
July 4, 2022
Last Verified
July 1, 2022
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- REC-FSD-00267
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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