NCT06740617

Brief Summary

this study will be conducted to investigate the difference in balance and ankle proprioception between calcaneus spur patients and age matched normal subjects

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
52

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Dec 2024

Shorter than P25 for all trials

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 14, 2024

Completed
4 days until next milestone

First Posted

Study publicly available on registry

December 18, 2024

Completed
7 days until next milestone

Study Start

First participant enrolled

December 25, 2024

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 30, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 30, 2025

Completed
Last Updated

December 18, 2024

Status Verified

December 1, 2024

Enrollment Period

1 month

First QC Date

December 14, 2024

Last Update Submit

December 14, 2024

Conditions

Keywords

calcaneal spurbalanceankle proprioception

Outcome Measures

Primary Outcomes (4)

  • dynamic balance

    the Biodex Balance System (BBS) ,Version 3.1, has been used to evaluate postural balance

    up to one day

  • static balance

    The single-leg stance balance test will be used to assess static balance.

    up to one day

  • ankle propriception

    digital inclinometer will be used to assessed ankle proprioception

    up to one day

  • foot disability

    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 Outcomes (1)

  • integrity of the plantar fascia ligament

    up to one day

Study Arms (2)

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

Eligibility Criteria

Age40 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

fifty two subjects will be assigned to two group; group with calcaneal spur and healthy group

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Heel Spur

Condition Hierarchy (Ancestors)

ExostosesHyperostosisBone DiseasesMusculoskeletal DiseasesFoot Diseases

Central Study Contacts

Mai A Farahat, master

CONTACT

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
principle investigator: mai afifi saad farahat

Study Record Dates

First Submitted

December 14, 2024

First Posted

December 18, 2024

Study Start

December 25, 2024

Primary Completion

January 30, 2025

Study Completion

January 30, 2025

Last Updated

December 18, 2024

Record last verified: 2024-12