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CompletedNCT05161364Updated Feb 10, 2023

Kinetic Analysis Due to Foot Dysfunction

An observational study in Amputation and Neuropathy;Peripheral, sponsored by Delta University for Science and Technology. Completed at 1 site in Egypt. Open to participants aged 40 Years to 65 Years. Per ClinicalTrials.gov, last updated 2023-02-10.

Sponsored by Delta University for Science and Technology · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
70
Ages
40 Years to 65 Years
Sex
All
01

Study summary

The aim of the current study is to examine the biomechanical changes of gait kinetics in patients with either partial foot amputation or peripheral neuropathy

02

Conditions studied

  • Amputation
  • Neuropathy;Peripheral
03

In context

Peripheral Nervous System Diseases

1,003 studies on the registry are indexed under Peripheral Nervous System Diseases; 177 are open to participants now.

This study's enrollment of 70 is below the median of 90 across 188 observational studies indexed under Peripheral Nervous System Diseases.

Browse Peripheral Nervous System Diseases studies →

Lead sponsor

Delta University for Science and Technology is the lead sponsor of 82 studies on the registry; 15 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
40 Years to 65 Years
Sexes eligible
All
Sampling method
Probability sample

Study population

Convenient 70 patients with 35 patients in each group of both genders ranging in age from 40 to 65 years will participate in this study after examination to exclude any defined pathological conditions. Participants will be recruited from foot amputation centers and outpatient clinics in Mansoura and Damietta, Egypt. All the participants were capable of walking independently to perform their activities of daily life with or without a walking aid. However, no walking aids were used during the testing procedures.

Inclusion criteria

  • Partial foot amputees who didn"t receive physiotherapy and don"t use prosthesis. patients with PN grade (1-2) Age 40-65y Both sexes. Walking independently however, no walking aids were used during the testing procedures

Exclusion criteria

Exclusion Criteria:

  • Foot amputation levels more proximal than tarso metatarsal joint. Less than 4 months after partial foot amputation. Foot amputees who use prosthesis or suffer from phantom pain. Active foot problems; ulcer, infection, or gangrene. Patients with PN who received physiotherapy or injections like Puerarin Major surgeries in lower limb that could affect either gait or balance like ACL, hip/knee arthroplasty Spine problems that could affect either gait or balance History of ankle sprain. Pathologies such as skin diseases, inflammatory diseases, congenital diseases, or neurological diseases rather than PN.

Fractures or dislocations. Symptomatic degenerative changes that require medications. BMI over 35. Inability of walking independently

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
70 participants (actual)
Patient registry
No

Groups and cohorts

  • A: PFA

    partial foot amputation secondary to peripheral neuropathy

  • B: PN

    peripheral neuropathy

06

What researchers measure

Primary outcomes

  1. GRF

    Ground Reaction Force

    Time frame: 5 minutes

  2. Planter Pressure

    Peak Planter Pressure

    Time frame: 3 minutes

  3. Planter Pressure distribution

    Planter Pressure distribution

    Time frame: 4 minutes

  4. Foot surface area

    Foot surface area

    Time frame: 6 minutes

07

Study locations

1 site
  • Delta university
    Gamasa, Eldakahlyia, Egypt
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 10, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT05161364
Lead sponsor
Delta University for Science and Technology
Responsible party
Omar Mohamed Ali Elabd (Assistant lecturer, Delta University for Science and Technology) — Principal investigator
First posted
Dec 17, 2021
Start date
Sep 13, 2021
Primary completion
Jan 1, 2022
Completion
Mar 1, 2022
Last update
Feb 10, 2023

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Dec 2021. You cannot join it, but the record below documents what was studied.

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