AmputationNCT05161364
Kinetic Analysis Due to Foot Dysfunction
An observational study of Amputation and Neuropathy;Peripheral, run by Delta University for Science and Technology at 1 site in Egypt.
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 Read more about this study
- Who is it for?
- Ages 40 to 65 years
- Conditions the study is for
- Amputation, Neuropathy;Peripheral
- How many people
- 70 participants
- Where
- 1 siteEgypt
- Study dates
- 13 Sep 2021to 1 Mar 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 65 years
- All sexes
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
- Conditions
- Amputation, Neuropathy;Peripheral
- Medical subject headings
- Neuritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| A: PFA | partial foot amputation secondary to peripheral neuropathy | |
| B: PN | peripheral neuropathy |
What is being measured
The primary outcome is the main question the study is designed to answer.
GRF
Ground Reaction Force
Measured: 5 minutes
Planter Pressure
Peak Planter Pressure
Measured: 3 minutes
Planter Pressure distribution
Planter Pressure distribution
Measured: 4 minutes
Foot surface area
Foot surface area
Measured: 6 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2021
- Study start13 Sep 2021
- Primary completion1 Jan 2022
- Study completion1 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AmputationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Delta University for Science and Technology
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Omar Mohamed Ali Elabd, Delta University for Science and Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05161364
- Sponsor's protocol ID
- 0224786
- Status last verified
- Dec 2021
- First submitted
- 3 Dec 2021
- Last updated
- 10 Feb 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analysis of Gait Kinetics in Patients With Foot Dysfunction Either Physiological or Anatomical
- ClinicalTrials.gov ID
- NCT05161364
- Acronym / sponsor ID
- 0224786
- Conditions
- Amputation, Neuropathy;Peripheral
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Delta University for Science and TechnologyUniversity, hospital or other
- Study start
- 13 Sep 2021 (actual)
- Primary completion
- 1 Jan 2022 (actual)
- Study completion
- 1 Mar 2022 (actual)
- First posted
- 17 Dec 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A: PFA | – | –partial foot amputation secondary to peripheral neuropathy |
| B: PN | – | –peripheral neuropathy |
Who may qualify
- Ages
- 40 to 65 years
- Sex
- All
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
GRF
Time frame: 5 minutes
Ground Reaction Force
Planter Pressure
Time frame: 3 minutes
Peak Planter Pressure
Planter Pressure distribution
Time frame: 4 minutes
Planter Pressure distribution
Foot surface area
Time frame: 6 minutes
Foot surface area
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Amputation and Neuropathy;Peripheral, run by Delta University for Science and Technology at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
GRF (time frame: 5 minutes). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Feb 2023.