NCT03249883

Brief 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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
14

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2017

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 26, 2017

Completed
2 months until next milestone

First Posted

Study publicly available on registry

August 15, 2017

Completed
17 days until next milestone

Study Start

First participant enrolled

September 1, 2017

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2018

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2019

Completed
Last Updated

August 15, 2017

Status Verified

June 1, 2017

Enrollment Period

1.1 years

First QC Date

June 26, 2017

Last Update Submit

August 13, 2017

Conditions

Amputation

Keywords

prosthetic feetdouble blind studylimited ambulatorsSACH footprosthetic components comparison

Outcome Measures

Primary Outcomes (6)

  • 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 Outcomes (2)

  • Gait patterns

    Measured after 3 weeks and

  • Gait patterns

    Measured after 6 weeks

Study Arms (2)

SACH first

ACTIVE COMPARATOR

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

1M10 first

ACTIVE COMPARATOR

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

Interventions

SACH prosthetic foot, 1M10 prosthetic footDEVICE

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 firstSACH first

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • unilateral transtibial amputees
  • limited ambulators

You may not qualify if:

  • do not speak Hebrew
  • are not cognitively intact

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (13)

  • 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.

    PMID: 24296024RESULT

  • 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.

    PMID: 24925671RESULT

  • 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.

    PMID: 24418934RESULT

  • 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.

    PMID: 12296985RESULT

  • 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.

    PMID: 17707643RESULT

  • Edelstein JE. Prosthetic feet. State of the Art. Phys Ther. 1988 Dec;68(12):1874-81. doi: 10.1093/ptj/68.12.1874.

    PMID: 3057523RESULT

  • 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.

    RESULT

  • 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.

    PMID: 17162519RESULT

  • 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.

    PMID: 24597518RESULT

  • 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.

    PMID: 21889241RESULT

  • 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.

    PMID: 11807327RESULT

  • 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.

    PMID: 6522257RESULT

  • 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.

    PMID: 10779119RESULT

Study Officials

  • Hagay Amir, MD

    Director of Orthopedic rehabilitation Department

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Hagay Amir, MD

CONTACT

972-50-6263379hagayam@clalit.org.il

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 26, 2017

First Posted

August 15, 2017

Study Start

September 1, 2017

Primary Completion

October 1, 2018

Study Completion

March 1, 2019

Last Updated

August 15, 2017

Record last verified: 2017-06

Data Sharing

IPD Sharing
Will not share