Amputation
Conditions
Keywords
prosthetic feet, double blind study, limited ambulators, SACH foot, prosthetic components comparison
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.
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.
Interventions
DEVICESACH 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.
Sponsors
Tel Aviv University
Loewenstein Hospital
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
SUPPORTIVE_CARE
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* unilateral transtibial amputees * limited ambulators
Exclusion criteria
* do not speak Hebrew * are not cognitively intact
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Gait patterns | Measured after 3 weeks and | Digital foot pressure patterns and gait parameters of the participants walking on a gait mat. |
Contacts
Primary ContactHagay Amir, MD
Outcome results
None listed