Comparison of Prosthetic Feet for the Geriatric Patients(CPF)

Amputation Clinical Trial

— CPF  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03249883
• Other study ID #: 0027-14-LOE
• Status: Not yet recruiting
• Phase: N/A
• First received: June 26, 2017
• Last updated: August 13, 2017
• Start date: September 1, 2017
• Est. completion date: March 2019

Study information

• Verified date: June 2017
• Source: Loewenstein Hospital
• Contact: Hagay Amir, MD
• Phone: 972-50-6263379
• Email: hagayam[@]clalit.org.il
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 14
• Est. completion date: March 2019
• Est. primary completion date: October 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• unilateral transtibial amputees

• limited ambulators

Exclusion Criteria:

• do not speak Hebrew

• are not cognitively intact

Related Conditions & MeSH terms

• Amputation

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Loewenstein Hospital	Tel Aviv University

References & Publications (13)

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: 10.1177/0309364614 — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. Review. — View Citation

Edelstein JE. Prosthetic feet. State of the Art. Phys Ther. 1988 Dec;68(12):1874-81. Review. — View Citation

Goh JC, Solomonidis SE, Spence WD, Paul JP. Biomechanical evaluation of SACH and uniaxial feet. Prosthet Orthot Int. 1984 Dec;8(3):147-54. — View Citation

Graham LA, Fyfe NC. Prosthetic rehabilitation of amputees aged over 90 is usually successful. Disabil Rehabil. 2002 Sep 10;24(13):700-1. — View Citation

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. — View Citation

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.cli — View Citation

Quesada PM, Pitkin M, Colvin J. Biomechanical evaluation of a prototype foot/ankle prosthesis. IEEE Trans Rehabil Eng. 2000 Mar;8(1):156-9. — View Citation

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. Epub 2007 Aug 17. — View Citation

* Note: There are 13 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Prosthetic satisfaction Questionnaire	Hebrew satisfaction questionnaire	Measured after 3 weeks
Primary	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
Primary	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
Primary	Prosthetic Satisfaction Questionnaire	Hebrew satisfaction questionnaire	Measured after 6 weeks
Primary	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
Primary	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	Gait patterns	Digital foot pressure patterns and gait parameters of the participants walking on a gait mat.	Measured after 3 weeks and
Secondary	Gait patterns	Digital foot pressure patterns and gait parameters of the participants walking on a gait mat.	Measured after 6 weeks