Plantar FascitisNCT05207592
Urdu Version of Foot and Ankle Disability Index: A Reliability and Validity Study
An observational study of Plantar Fascitis, run by Riphah International University at 1 site in Pakistan.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Plantar Fascitis
- How many people
- 70 participants
- Where
- 1 sitePakistan
- Study dates
- 30 May 2021to 28 Feb 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: The participant included in this study will be the patients of plantar fasciitis including both genders.
Who may be able to join
- 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
Who cannot join
- Recent foot injury
- Fracture
- Infections
- Surgical procedures
- Tendon injury
- Hypermobility
Show all 14Show fewer
- Neuromuscular disorders
- Impaired sensation
- Open sores
- Skin disease
- Active deep vein thrombosis or thrombophlebitis
- Bruises
- Varicose veins
- Burn Scars
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
Ripah International University
Faisalabad, Punjab Province, 38000
About this study
Official title: 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.
Read the 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.
- Conditions
- Plantar Fascitis
- Keywords
- Foot and Ankle Disability Index, Plantar Fascitis, Cultural adaptation, Validity, Urdu Version, Reliability
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1st day
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.
Measured: 1st day
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.
Measured: 1st day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2022
- Study start30 May 2021
- Primary completion15 Feb 2022
- Study completion28 Feb 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Plantar FascitisStudies of the same condition, open and under way.
- More trials run by Riphah International UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Ecologic or community
- Time perspective
- Cross-sectional
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Muhammad Kashif, Study chair, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05207592
- Sponsor's protocol ID
- REC-FSD-00267
- Status last verified
- Jul 2022
- First submitted
- 24 Jan 2022
- Last updated
- 6 Jul 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Translation of Foot and Ankle Disability Index Into Local Urdu Language of Pakistan: A Reliability and Validity Study
- ClinicalTrials.gov ID
- NCT05207592
- Acronym / sponsor ID
- REC-FSD-00267
- Conditions
- Plantar Fascitis
- Keywords
- Foot and Ankle Disability Index, Plantar Fascitis, Cultural adaptation, Validity, Urdu Version, Reliability
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 30 May 2021 (actual)
- Primary completion
- 15 Feb 2022 (actual)
- Study completion
- 28 Feb 2022 (actual)
- First posted
- 26 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Ecologic or community
- Time perspective
- Cross-sectional
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The participant included in this study will be the patients of plantar fasciitis including both genders.
Key inclusion criteria (6 listed)
- Inability to achieve 20 degrees of active dorsiflexion
- Heel pain
- Mid foot pain
- Heal swelling
- Mid foot swelling
Key exclusion criteria (14 listed)
- Recent foot injury
- Fracture
- Infections
- Surgical procedures
- Tendon injury
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jul 2022.
- Individual participant dataSharing planned: No
Related trials for Plantar Fascitis
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F-18 Sodium Fluoride PET/CT-Guided Pain Palliation in Chronic Plantar Fasciitis: A Comparative Study of ¹⁷⁷Lutetium-Corticosteroid-Local Anaesthetic Injection vs Corticosteroid-Local Anaesthetic Injection
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Muhammad Kashif study chair
Riphah International University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Plantar Fascitis, run by Riphah International University at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Foot and Ankle Disability Index (time frame: 1st day). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jul 2022.