AmputationCPFNCT03249883
Comparison of Prosthetic Feet for the Geriatric Patients(CPF)
A study testing SACH prosthetic foot, 1M10 prosthetic foot in people with Amputation, run by Loewenstein Hospital.
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Amputation
- What is being tested?
- SACH prosthetic foot, 1M10 prosthetic foot
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2017to Mar 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- unilateral transtibial amputees
- limited ambulators
Who cannot join
- do not speak Hebrew
- are not cognitively intact
Trial locations and contacts
No sites are listed yet.
About this study
Official title: 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.
Read the 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.
- Conditions
- Amputation
- Being tested
- SACH prosthetic foot, 1M10 prosthetic foot
- Keywords
- prosthetic feet, double blind study, limited ambulators, SACH foot, prosthetic components comparison
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Device: SACH prosthetic foot, 1M10 prosthetic foot |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prosthetic satisfaction Questionnaire
Hebrew satisfaction questionnaire
Measured: 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: 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: Measured after 3 weeks
Prosthetic Satisfaction Questionnaire
Hebrew satisfaction questionnaire
Measured: 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: 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: Measured after 6 weeks
Secondary outcomes (2)
Gait patterns
Digital foot pressure patterns and gait parameters of the participants walking on a gait mat.
Measured: Measured after 3 weeks and
Gait patterns
Digital foot pressure patterns and gait parameters of the participants walking on a gait mat.
Measured: Measured after 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2017
- Study start1 Sep 2017 (estimated)
- Primary completionOct 2018 (estimated)
- Study completionMar 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (13)Papers the sponsor has linked to this study.
- Other trials for AmputationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 14 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Loewenstein Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Tel Aviv University
- Responsible party
- Sponsor
- Investigators
- Hagay Amir, MD, Principal investigator, Director of Orthopedic rehabilitation Department
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03249883
- Sponsor's protocol ID
- 0027-14-LOE
- Acronym
- CPF
- Status last verified
- Jun 2017
- First submitted
- 26 Jun 2017
- Last updated
- 15 Aug 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 24296024Agrawal 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.
PubMed 24925671Bonnet 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.
PubMed 24418934Graham 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.
PubMed 12296985Vickers 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.
PubMed 17707643Edelstein JE. Prosthetic feet. State of the Art. Phys Ther. 1988 Dec;68(12):1874-81. doi: 10.1093/ptj/68.12.1874.
PubMed 3057523Hansen 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.
PubMed 17162519Arifin 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.
PubMed 24597518Nederhand 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.
PubMed 21889241Buckley 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.
PubMed 11807327Goh 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.
PubMed 6522257Quesada 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.
PubMed 10779119
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of a Geriatric Foot- 1M10 ADJUST Versus the Solid Ankle Cushioned Heel Foot for Low Activity Amputees
- ClinicalTrials.gov ID
- NCT03249883
- Acronym / sponsor ID
- CPF / 0027-14-LOE
- Conditions
- Amputation
- Keywords
- prosthetic feet, double blind study, limited ambulators, SACH foot, prosthetic components comparison
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 14 participants (estimated)
- Lead sponsor
- Loewenstein HospitalUniversity, hospital or other
- Collaborators
- Tel Aviv University
- Study start
- 1 Sep 2017 (estimated)
- Primary completion
- Oct 2018 (estimated)
- Study completion
- Mar 2019 (estimated)
- First posted
- 15 Aug 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SACH first | Active comparator | Device: SACH prosthetic foot, 1M10 prosthetic footWill 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 footWill 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 |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- unilateral transtibial amputees
- limited ambulators
Key exclusion criteria (2 listed)
- do not speak Hebrew
- are not cognitively intact
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SACH prosthetic foot, 1M10 prosthetic footIn 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. | Device | 1M10 first, SACH first |
Primary outcome
Prosthetic satisfaction Questionnaire
Time frame: Measured after 3 weeks
Hebrew satisfaction questionnaire
10 meter walk test
Time frame: 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
Time frame: 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
Time frame: Measured after 6 weeks
Hebrew satisfaction questionnaire
10 meter walk test
Time frame: 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
Time frame: 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
2 secondary outcomes
Gait patterns
Time frame: Measured after 3 weeks and
Gait patterns
Time frame: Measured after 6 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Aug 2017.
- Results publication: PubMed 24296024Chitragari 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.
- Results publication: PubMed 24925671Agrawal 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.
- Results publication: PubMed 24418934Bonnet 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.
- Results publication: PubMed 12296985Graham 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.
- Results publication: PubMed 17707643Vickers 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.
- Results publication: PubMed 3057523Edelstein JE. Prosthetic feet. State of the Art. Phys Ther. 1988 Dec;68(12):1874-81. doi: 10.1093/ptj/68.12.1874.
- Results publicationHansen 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: PubMed 17162519Hansen 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.
- Results publication: PubMed 24597518Arifin 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.
- Results publication: PubMed 21889241Nederhand 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.
- Results publication: PubMed 11807327Buckley 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.
- Results publication: PubMed 6522257Goh 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hagay Amir, MD principal investigator
Director of Orthopedic rehabilitation Department
Questions about this trial
What is this clinical trial studying?
A study testing SACH prosthetic foot, 1M10 prosthetic foot in people with Amputation, run by Loewenstein Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hagay Amir, MD (972-50-6263379, hagayam@clalit.org.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prosthetic satisfaction Questionnaire (time frame: Measured after 3 weeks). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03249883, which also lists 13 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Aug 2017.