- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05691998
Comparison of Different Types of Prosthetic Foott
January 11, 2023 updated by: Yasin Demir, Gaziler Physical Medicine and Rehabilitation Education and Research Hospital
Comparison of Different Types of Prosthetic Foot: Patient Perspective
The main purpose of this study is to determine the experiences of patients with different types of prostetic feet (carbon, hydraulic or microprocessor controlled).
Study Overview
Status
Not yet recruiting
Intervention / Treatment
Detailed Description
One of the main goals in the rehabilitation of amputees is to provide optimal and natural ambulation.
For this purpose, suitable socket-suspension type, appropriate knee joint and foot should be prescribed.
In the selection of feet, the age, occupation, characteristics of the geographical region, mental status and activity level should be considered.
In addition, the previous prosthesis experience of the people should definitely be taken into account during prosthesis prescribing.The main purpose of this study is to determine the experiences of patients with different types of prostetic feet (carbon, hydraulic or microprocessor controlled).
Study Type
Observational
Enrollment (Anticipated)
20
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Yasin Demir, Associated Professor
- Phone Number: +903122911806
- Email: dr_yasindemir@yahoo.com
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
A total of 20 patients with lower limb amputation
Description
Inclusion Criteria:
- Aged between 18-65 years
- Lower limb amputation
- Having used at least 2 different foot types (carbon, hydrolic, microprocessor-controlled)
Exclusion Criteria:
- Having used the single type of foot until now
- Presence of neurological, cardiovascular, and pulmonary disease that may affect walking performance
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Case-Only
- Time Perspectives: Cross-Sectional
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Patients
the previous prosthesis experience
|
Prosthetic foot related questions will be asked to the patients
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Qestion 1
Time Frame: through study completion, an average of one and a half months
|
Walking on the straight road
|
through study completion, an average of one and a half months
|
|
Qestion 2
Time Frame: through study completion, an average of one and a half months
|
Walking on uneven terrain
|
through study completion, an average of one and a half months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Yasin Demir, Associated Professor, dr_yasindemir@yahoo.com
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Anticipated)
January 25, 2023
Primary Completion (Anticipated)
March 1, 2023
Study Completion (Anticipated)
April 1, 2023
Study Registration Dates
First Submitted
January 11, 2023
First Submitted That Met QC Criteria
January 11, 2023
First Posted (Actual)
January 20, 2023
Study Record Updates
Last Update Posted (Actual)
January 20, 2023
Last Update Submitted That Met QC Criteria
January 11, 2023
Last Verified
January 1, 2023
More Information
Terms related to this study
Other Study ID Numbers
- 33
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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