NCT03249883

Comparison of Prosthetic Feet for the Geriatric Patients(CPF)

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 14 (estimated)
• Sponsor: Loewenstein Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Amputation

Interventions

Type	Name	Description
DEVICE	SACH 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.

Timeline

• Start date: 2017-09-01
• Primary completion: 2018-10-01
• Completion: 2019-03-01
• First posted: 2017-08-15
• Last updated: 2017-08-15