Kinetic Analysis Due to Foot Dysfunction

Analysis of Gait Kinetics in Patients With Foot Dysfunction Either Physiological or Anatomical

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

Study Overview

• Status: Completed
• Conditions: Amputation; Neuropathy;Peripheral

• Study Type: Observational
• Enrollment (Actual): 70

Contacts and Locations

Study Locations

• Egypt
  • Eldakahlyia
    • Gamasa, Eldakahlyia, Egypt
      • Delta University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: 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.

Description

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:

• 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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
A: PFA; partial foot amputation secondary to peripheral neuropathy
B: PN; peripheral neuropathy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
GRF	Ground Reaction Force	5 minutes
Planter Pressure	Peak Planter Pressure	3 minutes
Planter Pressure distribution	Planter Pressure distribution	4 minutes
Foot surface area	Foot surface area	6 minutes

Collaborators and Investigators

• Sponsor: Delta University for Science and Technology

Study record dates

Study Major Dates

• Study Start (ACTUAL): September 13, 2021
• Primary Completion (ACTUAL): January 1, 2022
• Study Completion (ACTUAL): March 1, 2022

Study Registration Dates

• First Submitted: December 3, 2021
• First Submitted That Met QC Criteria: December 3, 2021
• First Posted (ACTUAL): December 17, 2021

Study Record Updates

• Last Update Posted (ACTUAL): February 10, 2023
• Last Update Submitted That Met QC Criteria: February 8, 2023
• Last Verified: December 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Neuromuscular Diseases; Peripheral Nervous System Diseases
• Other Study ID Numbers: 0224786

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No