- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06740617
Evaluation Of Balance And Ankle Proprioception In Calcaneal Spur Patients (CS)
December 14, 2024 updated by: Mai Afifi Saad Mohamed Farahat, Cairo University
this study will be conducted to investigate the difference in balance and ankle proprioception between calcaneus spur patients and age matched normal subjects
Study Overview
Status
Not yet recruiting
Conditions
Detailed Description
A calcaneal spur, also known as enthesophyte, is an abnormal bone outgrowth at the inferior part of the calcaneus, which is the most common site of bony spur occurrence.
Although there is consensus that a calcaneal spur is a common cause of heel pain, approximately 20% of calcaneal spurs are asymptomatic and its pathology remains not fully understood.Ankle Joint Position Sense (JPS) refers to the ability to accurately perceive and reproduce the position of the ankle joint in space.
Balance, on the other hand, encompasses the ankle joint's positional stability during both static and dynamic activities.Several investigations have demonstrated a significant association between ankle JPS and balance, indicating that individuals with better proprioceptive acuity in the ankle joint tend to exhibit superior postural stability, ).
It was found that higher plantar fascia and heel fat pad stiffness and thickness are related to higher postural sway in anterior-posterior and medial-lateral directions based on the single-leg balance tests.
These results suggest that the morphological and mechanical properties of plantar fascia and heel fat pad play an important role in balance performance.
Study Type
Observational
Enrollment (Estimated)
52
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Mai A Farahat, master
- Phone Number: 01025038690
- Email: maiafifi85@gmail.com
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
- Adult
Accepts Healthy Volunteers
Yes
Sampling Method
Non-Probability Sample
Study Population
fifty two subjects will be assigned to two group; group with calcaneal spur and healthy group
Description
Inclusion Criteria:
- age will range from 40-60
- both sex male and female
- unilateral calcaneal spur
- Patients with pain and inflammation at the bottom of heel, or the location where the spur is present.
- All subjects have body mass index less than 29 kg/cm2
- sharp pain like a knife in the heel when standing up in the morning
- pain may also appear at the end of the day or after spending long periods of time on the feet
- sharp pain with the first steps in the morning or after a long period of rest and dissipating when weight bearing is initiated.
- All diagnosed patients, were evaluated and confirmed radiologically by specialist doctor, by performing a standard X-ray foot profile image
Exclusion Criteria:
- Surgery within the last 6 months
- Sensory or motor paralysis -Received steroid injections within the last 3 months-
- discrepancy in length of the lower extremities greater than or equal to 1 cm.
- systemic disease in the last six months that may predispose to heel pain(e.g., rheumatoid arthritis and lupus). (Dudoniene V et al.,2023).
- Calcaneal spurs are associated with various medical conditions, including obesity, rheumatoid arthritis, osteoarthritis, ankylosing spondylitis, Reiter's disease, and spondylarthritis.
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
Cohorts and Interventions
Group / Cohort |
|---|
|
calcaneal spur group
twenty six patients with calcaneal spur will participate in this group
|
|
healthy group
twenty six healthy subjects will participate in this group
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
dynamic balance
Time Frame: up to one day
|
the Biodex Balance System (BBS) ,Version 3.1, has been used to evaluate postural balance
|
up to one day
|
|
static balance
Time Frame: up to one day
|
The single-leg stance balance test will be used to assess static balance.
|
up to one day
|
|
ankle propriception
Time Frame: up to one day
|
digital inclinometer will be used to assessed ankle proprioception
|
up to one day
|
|
foot disability
Time Frame: up to one day
|
A Foot Function Index (FFI) will be used to assess foot disability.
The pain subcategory consists of 9 items and measures foot pain in different situations, such as walking barefoot versus walking with shoes.
The disability subcategory consists of 9 items and measures difficulty performing various functional activities because of foot problems, such as difficulty climbing stairs.
The activity limitation subcategory consists of 5 items and measures limitations in activities because of foot problems, such as staying in bed all day.
Recorded on a visual analogue scale (VAS), scores range from 0 to 100 mm, with higher scores indicating worse pain.
Both total and subcategory scores are calculated
|
up to one day
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
integrity of the plantar fascia ligament
Time Frame: up to one day
|
The Windlass Test is a physical examination technique will be used to assess the integrity of the plantar fascia ligament in the foot.
we evaluated the Windlass test, and found it had a high specificity, and a low level of sensitivity.
It can be used as part of the clinician's armamentarium in evaluating patients with plantar fasciitis, and should be performed in a weightbearing position to maximize the sensitivity
|
up to one 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 (Estimated)
December 25, 2024
Primary Completion (Estimated)
January 30, 2025
Study Completion (Estimated)
January 30, 2025
Study Registration Dates
First Submitted
December 14, 2024
First Submitted That Met QC Criteria
December 14, 2024
First Posted (Actual)
March 25, 2025
Study Record Updates
Last Update Posted (Actual)
March 25, 2025
Last Update Submitted That Met QC Criteria
December 14, 2024
Last Verified
December 1, 2024
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- P.T.REC/012/005501
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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