Comparison of Prosthetic Feet for the Geriatric Patients(CPF)
NCT ID: NCT03249883
Last Updated: 2017-08-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
NA
14 participants
INTERVENTIONAL
2017-09-01
2019-03-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Comparison Between Three Types of Prosthetic Feet
NCT03046394
Efficiency of Hydraulic Microprocessor Prosthetic Foot for Traumatic Transtibial Amputees
NCT02383446
Study on a Prosthetic Foot With Adjustable Heel Height
NCT07214493
Comparing Active and Passive Ankle-foot Prostheses
NCT01684501
Biomechanical Study of Different Prostheses for Unilateral Transtibial Amputees During Indoor and Outdoor Activities
NCT06390033
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Both types of feet will be "dressed" to look similarly. All participants will receive the same rehabilitation protocol. After three weeks all participants will be tested functionally in the "10 meter walk test" , and a "Get up and go test". The participants will answer a satisfaction questionnaire that is based on the "Prosthesis Evaluation Questionnaire" and modified according to the aims of this trial.
Pressure patterns and gait parameters will be recorded using a pressure mat. At this time the foot will be switched to the other study prosthetic foot, and the rehabilitation will commence.
At the end of three weeks wearing the new foot the same set of tests will be run again.
The investigators aim to present the difference in satisfaction and in the functional performance of the same participant wearing the two feet.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
CROSSOVER
SUPPORTIVE_CARE
TRIPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
SACH first
Will use a SACH foot for the first three weeks of prosthetic gait training , and a 1M10 foot for the second three weeks of prosthetic gait training
SACH prosthetic foot, 1M10 prosthetic foot
In the SACH first group - the amputees will wear the SACH feet for three weeks and then switch to 1M10 feet for another three weeks.
In the 1M10 first group - the amputees will wear the 1M10 feet for three weeks and then switch to SACH feet for another three weeks.
1M10 first
Will use a 1M10 foot for the first three weeks of prosthetic gait training , and a SACH foot for the second three weeks of prosthetic gait training
SACH prosthetic foot, 1M10 prosthetic foot
In the SACH first group - the amputees will wear the SACH feet for three weeks and then switch to 1M10 feet for another three weeks.
In the 1M10 first group - the amputees will wear the 1M10 feet for three weeks and then switch to SACH feet for another three weeks.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
SACH prosthetic foot, 1M10 prosthetic foot
In the SACH first group - the amputees will wear the SACH feet for three weeks and then switch to 1M10 feet for another three weeks.
In the 1M10 first group - the amputees will wear the 1M10 feet for three weeks and then switch to SACH feet for another three weeks.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* limited ambulators
Exclusion Criteria
* are not cognitively intact
18 Years
80 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Tel Aviv University
OTHER
Loewenstein Hospital
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Hagay Amir, MD
Role: PRINCIPAL_INVESTIGATOR
Director of Orthopedic rehabilitation Department
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
References
Explore related publications, articles, or registry entries linked to this study.
Chitragari G, Mahler DB, Sumpio BJ, Blume PA, Sumpio BE. Prosthetic options available for the diabetic lower limb amputee. Clin Podiatr Med Surg. 2014 Jan;31(1):173-85. doi: 10.1016/j.cpm.2013.09.008.
Agrawal V, Gailey RS, Gaunaurd IA, O'Toole C, Finnieston A, Tolchin R. Comparison of four different categories of prosthetic feet during ramp ambulation in unilateral transtibial amputees. Prosthet Orthot Int. 2015 Oct;39(5):380-9. doi: 10.1177/0309364614536762. Epub 2014 Jun 12.
Bonnet X, Adde JN, Blanchard F, Gedouin-Toquet A, Eveno D. Evaluation of a new geriatric foot versus the Solid Ankle Cushion Heel foot for low-activity amputees. Prosthet Orthot Int. 2015 Apr;39(2):112-8. doi: 10.1177/0309364613515492. Epub 2014 Jan 13.
Graham LA, Fyfe NC. Prosthetic rehabilitation of amputees aged over 90 is usually successful. Disabil Rehabil. 2002 Sep 10;24(13):700-1. doi: 10.1080/09638280210142194.
Vickers DR, Palk C, McIntosh AS, Beatty KT. Elderly unilateral transtibial amputee gait on an inclined walkway: a biomechanical analysis. Gait Posture. 2008 Apr;27(3):518-29. doi: 10.1016/j.gaitpost.2007.06.008. Epub 2007 Aug 17.
Edelstein JE. Prosthetic feet. State of the Art. Phys Ther. 1988 Dec;68(12):1874-81. doi: 10.1093/ptj/68.12.1874.
Hansen A, Sam M, Childress D. The effective foot length ratio: a potential tool for characterization and eval¬uation of prosthetic feet. J Prosthet Orthot 2004; 16(2): 41-45.
Hansen AH, Meier MR, Sessoms PH, Childress DS. The effects of prosthetic foot roll-over shape arc length on the gait of trans-tibial prosthesis users. Prosthet Orthot Int. 2006 Dec;30(3):286-99. doi: 10.1080/03093640600816982.
Arifin N, Abu Osman NA, Ali S, Wan Abas WA. The effects of prosthetic foot type and visual alteration on postural steadiness in below-knee amputees. Biomed Eng Online. 2014 Mar 5;13(1):23. doi: 10.1186/1475-925X-13-23.
Nederhand MJ, Van Asseldonk EH, van der Kooij H, Rietman HS. Dynamic Balance Control (DBC) in lower leg amputee subjects; contribution of the regulatory activity of the prosthesis side. Clin Biomech (Bristol). 2012 Jan;27(1):40-5. doi: 10.1016/j.clinbiomech.2011.07.008. Epub 2011 Sep 1.
Buckley JG, O'Driscoll D, Bennett SJ. Postural sway and active balance performance in highly active lower-limb amputees. Am J Phys Med Rehabil. 2002 Jan;81(1):13-20. doi: 10.1097/00002060-200201000-00004.
Goh JC, Solomonidis SE, Spence WD, Paul JP. Biomechanical evaluation of SACH and uniaxial feet. Prosthet Orthot Int. 1984 Dec;8(3):147-54. doi: 10.3109/03093648409146077.
Quesada PM, Pitkin M, Colvin J. Biomechanical evaluation of a prototype foot/ankle prosthesis. IEEE Trans Rehabil Eng. 2000 Mar;8(1):156-9. doi: 10.1109/86.830960.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
0027-14-LOE
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.