Comparison of Prosthetic Feet for the Geriatric Patients(CPF)

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Amputation

Intervention / Treatment
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* Device: SACH prosthetic foot, 1M10 prosthetic foot


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: unilateral transtibial amputees limited ambulators Exclusion Criteria: do not speak Hebrew are not cognitively intact

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: SACH first<br>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<br>* 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.<br>|
| Active Comparator: 1M10 first<br>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<br>* 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.<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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prosthetic feet, double blind study, limited ambulators, SACH foot, prosthetic components comparison