Comparison of Prosthetic Feet for the Geriatric Patients(CPF) (CPF)

Evaluation of a Geriatric Foot- 1M10 ADJUST Versus the Solid Ankle Cushioned Heel Foot for Low Activity Amputees

The purpose of this study is to determine whether the geriatric prosthetic foot 1M10 is superior to the classical SACH (Solid Ankle Cushion Heel) foot, when used by indoor ambulators with a transtibial amputation.

Study Overview

• Status: Unknown
• Conditions: Amputation
• Intervention / Treatment: Device: SACH prosthetic foot, 1M10 prosthetic foot

Detailed Description

Fourteen limited ambulators , unilateral trans tibial amputees, will be recruited in the orthopedic rehabilitation department in our institute. Participants will be assigned randomly to be fitted with a SACH or a 1M10 Otto Bock foot in their prosthesis.

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.

• Study Type: Interventional
• Enrollment (Anticipated): 14
• Phase: Not Applicable

Contacts and Locations

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• unilateral transtibial amputees
• limited ambulators

Exclusion Criteria:

• do not speak Hebrew
• are not cognitively intact

Study Plan

How is the study designed?

Design Details

• Primary Purpose: SUPPORTIVE_CARE
• Allocation: RANDOMIZED
• Interventional Model: CROSSOVER
• Masking: TRIPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: 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	Device: 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.
ACTIVE_COMPARATOR: 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	Device: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Prosthetic satisfaction Questionnaire	Hebrew satisfaction questionnaire	Measured after 3 weeks
10 meter walk test	The participants will be asked to walk at their comfort pace 10 meters. The time of completing the task will be recorded	Measured after 3 weeks
Get up and go test	The participants will be asked to get up from a chair walk 3 meters turn around walk back to the chair and sit down. The time of completing the task will be recorded.	Measured after 3 weeks
Prosthetic Satisfaction Questionnaire	Hebrew satisfaction questionnaire	Measured after 6 weeks
10 meter walk test	The participants will be asked to walk at their comfort pace 10 meters. The time of completing the task will be recorded	Measured after 6 weeks
Get up and go test	The participants will be asked to get up from a chair walk 3 meters turn around walk back to the chair and sit down. The time of completing the task will be recorded	Measured after 6 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Gait patterns	Digital foot pressure patterns and gait parameters of the participants walking on a gait mat.	Measured after 3 weeks and
Gait patterns	Digital foot pressure patterns and gait parameters of the participants walking on a gait mat.	Measured after 6 weeks

Collaborators and Investigators

• Sponsor: Loewenstein Hospital
• Collaborators: Tel Aviv University
• Investigators: Principal Investigator: Hagay Amir, MD, Director of Orthopedic rehabilitation Department

Publications and helpful links

General Publications

• 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, Avon). 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.

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): September 1, 2017
• Primary Completion (ANTICIPATED): October 1, 2018
• Study Completion (ANTICIPATED): March 1, 2019

Study Registration Dates

• First Submitted: June 26, 2017
• First Submitted That Met QC Criteria: August 13, 2017
• First Posted (ACTUAL): August 15, 2017

Study Record Updates

• Last Update Posted (ACTUAL): August 15, 2017
• Last Update Submitted That Met QC Criteria: August 13, 2017
• Last Verified: June 1, 2017

More Information

Terms related to this study

• Keywords: double blind study; prosthetic feet; limited ambulators; SACH foot; prosthetic components comparison
• Other Study ID Numbers: 0027-14-LOE

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
• product manufactured in and exported from the U.S.: No