Evaluation of a Geriatric Foot- 1M10 ADJUST Versus the Solid Ankle Cushioned Heel Foot for Low Activity Amputees
| Registry | NCT03249883, acronym CPF |
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| Status | Unknown |
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| Phase | Not applicable |
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| Study type | Interventional; randomized, crossover, masking: triple, supportive care |
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| Enrollment | 14 (Estimated) |
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| Sponsor | Loewenstein Hospital (Other); collaborators: Tel Aviv University |
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| Conditions | Amputation |
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| Interventions | SACH prosthetic foot, 1M10 prosthetic foot (Device) |
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| Dates | start 2017-09-01 (estimated), primary completion 2018-10-01 (estimated), completion 2019-03-01 (estimated), first posted 2017-08-15, last updated 2017-08-15 |
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-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.
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+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.
+Arms and interventions
| Arm | Type | Interventions | Description |
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| SACH first | Active comparator | Device: SACH prosthetic foot, 1M10 prosthetic foot | 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 |
| 1M10 first | Active comparator | Device: SACH prosthetic foot, 1M10 prosthetic foot | 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 (Device): 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.
+Outcome measures
Primary outcomes
- Prosthetic satisfaction Questionnaire [Measured after 3 weeks]: Hebrew satisfaction questionnaire
- 10 meter walk test [Measured after 3 weeks]: The participants will be asked to walk at their comfort pace 10 meters. The time of completing the task will be recorded
- Get up and go test [Measured after 3 weeks]: 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.
- Prosthetic Satisfaction Questionnaire [Measured after 6 weeks]: Hebrew satisfaction questionnaire
- 10 meter walk test [Measured after 6 weeks]: The participants will be asked to walk at their comfort pace 10 meters. The time of completing the task will be recorded
- Get up and go test [Measured after 6 weeks]: 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
Secondary outcomes
- Gait patterns [Measured after 3 weeks and]: Digital foot pressure patterns and gait parameters of the participants walking on a gait mat.
- Gait patterns [Measured after 6 weeks]: Digital foot pressure patterns and gait parameters of the participants walking on a gait mat.
+Eligibility
Sex: All, ages: 18 Years to 80 Years
Inclusion Criteria:
* unilateral transtibial amputees
* limited ambulators
Exclusion Criteria:
* do not speak Hebrew
* are not cognitively intact
+Publications
- Results publication: 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 24296024
- Results publication: 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 24925671
- Results publication: 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 24418934
- Results publication: 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 12296985
- Results publication: 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 17707643
- Results publication: Edelstein JE. Prosthetic feet. State of the Art. Phys Ther. 1988 Dec;68(12):1874-81. doi: 10.1093/ptj/68.12.1874. PMID 3057523
- Results publication: 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.
- Results publication: 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 17162519
- Results publication: 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 24597518
- Results publication: 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 21889241
- Results publication: 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 11807327
- Results publication: 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 6522257
- Results publication: 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 10779119
+Investigators
- Hagay Amir, MD, Principal investigator, Director of Orthopedic rehabilitation Department