NCT07589192

Brief Summary

The goal of this observational cross sectionl study is to explore the correlation between Böhler angle and dynamic postural stability indices after calcaneal internal fixation. in calcaneal fracture post internal fixation both gender, (18-40) yr.

Trial Health

63
Monitor

Trial Health Score

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

Enrollment
80

participants targeted

Target at P50-P75 for all trials

Timeline
24mo left

Started May 2026

Geographic Reach
1 country

1 active site

Status
not yet recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress2%
May 2026Apr 2028

First Submitted

Initial submission to the registry

April 29, 2026

Completed
11 days until next milestone

Study Start

First participant enrolled

May 10, 2026

Completed
5 days until next milestone

First Posted

Study publicly available on registry

May 15, 2026

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 15, 2028

Expected
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 15, 2028

Last Updated

May 15, 2026

Status Verified

May 1, 2026

Enrollment Period

1.7 years

First QC Date

April 29, 2026

Last Update Submit

May 9, 2026

Conditions

Body Balnace and Calcaneal Fractures

Keywords

Biodex balance systemeBohlar and Gissane anglesPost Operative Calcaneal Internal Fixation

Outcome Measures

Primary Outcomes (6)

  • 1. Anterior/Posterior stability index (APSI)

    Assessment of body balance

    single time point

  • Medial/Lateral stability index (MLSI)

    Assessment of body balance

    single time point

  • Overall stability index (OSI)

    Assessment of body balance

    single time point

  • Fall Risk index (FRI)

    Assessment of risk of fall

    single time point

  • Böhler angle

    calcaneal alignment angles

    single time point

  • Gissane angle

    calcaneal alignment angles

    single time point

Study Arms (1)

single group study

The group of study is the group of intervention who has calcaneal fracture and under wented internl fixation

Diagnostic Test: Biodex balance system

Interventions

Biodex balance systemDIAGNOSTIC_TEST

Assessment for body balance via Biodex Balance System

single group study

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

volunteers from both genders aged from 18 to 40 y who had calcaneal fracture and anderwent internal fixation will participate in the study

You may qualify if:

  • Participants referred from orthopedic surgeon with calcaneal fracture treated with internal fixation.
  • Adults aged 18-40 .
  • Unilateral displaced intra-articular calcaneal fracture .
  • Underwent internal fixation (plate/screws) .
  • At least 1 years follow up postoperative .
  • Able to stand independently.
  • Both males and females.

You may not qualify if:

  • Problems with cognition, vision, or any other medical issue that might compromise their ability to safely engage in the selected balancing measures should be avoided .
  • Those with foot or ankle sensitivity loss and a systemic inflammatory illness, including diabetes mellitus, rheumatoid arthritis, or ankylosing spondylitis .
  • Patients with vestibular or neurological disorders .
  • Accompanying lower limb and spine fractures, which required internal fixation, talus fractures, thoracolumbar burst fractures, femur fractures, and tibia fractures), severe knee arthrosis, postoperative osteomyelitis of the calcaneus, and subtalar arthrodesis performed before this study because of subtalar arthrosis and pain .
  • Patients who had lower limb dysfunction; and women who are pregnant and are in their lactation period .
  • Refusal to give informed consent to participate in the study .
  • Any associated fracture, bilateral fractures, associated peroneal tendon dislocation, postoperative wound breakdown and superficial or deep infection, age younger than .
  • Calcaneal heel spur
  • Foot deformity

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cairo University / Faculty of Physical Therapy

Cairo, Dokki, Egypt

Location

Study Officials

  • Azza M Abdelmohsen, Assistant Professor of Biomech

    Cairo University

    STUDY CHAIR

Central Study Contacts

Nassif M Mousa, Master

CONTACT

+201273152233nassif.magdy.mousa@gmail.com

Azza M Abdelmohsen, Assistant Professor of Biomech

CONTACT

0201145046304dr_azzamohammed@yahoo.com

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Target Duration
1 Day
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant lecturer

Study Record Dates

First Submitted

April 29, 2026

First Posted

May 15, 2026

Study Start

May 10, 2026

Primary Completion (Estimated)

January 15, 2028

Study Completion (Estimated)

April 15, 2028

Last Updated

May 15, 2026

Record last verified: 2026-05

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)