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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05161364
Other study ID # 0224786
Secondary ID
Status Completed
Phase
First received
Last updated
Start date September 13, 2021
Est. completion date March 1, 2022

Study information

Verified date December 2021
Source Delta University for Science and Technology
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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


Recruitment information / eligibility

Status Completed
Enrollment 70
Est. completion date March 1, 2022
Est. primary completion date January 1, 2022
Accepts healthy volunteers
Gender All
Age group 40 Years to 65 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Locations

Country Name City State
Egypt Delta university Gamasa Eldakahlyia

Sponsors (1)

Lead Sponsor Collaborator
Delta University for Science and Technology

Country where clinical trial is conducted

Egypt, 

Outcome

Type Measure Description Time frame Safety issue
Primary GRF Ground Reaction Force 5 minutes
Primary Planter Pressure Peak Planter Pressure 3 minutes
Primary Planter Pressure distribution Planter Pressure distribution 4 minutes
Primary Foot surface area Foot surface area 6 minutes
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