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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05207592
Other study ID # REC-FSD-00267
Secondary ID
Status Completed
Phase
First received
Last updated
Start date May 30, 2021
Est. completion date February 28, 2022

Study information

Verified date July 2022
Source Riphah International University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 70
Est. completion date February 28, 2022
Est. primary completion date February 15, 2022
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility 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 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 Foot and Ankle Disability Index 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
Primary 36-Item Short Form Survey 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
Primary Visual Analogue Scale 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
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