Comparison of Prosthetic Feet for the Geriatric Patients(CPF)

Not Applicable

• Conditions: Amputation
• Interventions: Device: SACH prosthetic foot, 1M10 prosthetic foot

• Registration Number: NCT03249883
• Lead Sponsor: Loewenstein Hospital

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.

Study Timeline

• Status Verified: 2017-06
• Study First Submitted: 2017-06-26
• Study First Submitted QC: 2017-08-13
• Last Update Submitted: 2017-08-13
• Study First Posted: 2017-08-15
• Last Update Posted: 2017-08-15
• Study Start: 2017-09-01
• Primary Completion: 2018-10
• Study Completion: 2019-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 14

Inclusion Criteria

• unilateral transtibial amputees
• limited ambulators

Exclusion Criteria

• do not speak Hebrew
• are not cognitively intact

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
SACH first	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	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

Primary Outcome Measures

Name	Time	Method
Prosthetic satisfaction Questionnaire	Measured after 3 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
Prosthetic Satisfaction Questionnaire	Measured after 6 weeks	Hebrew satisfaction questionnaire

Secondary Outcome Measures

Name	Time	Method
Gait patterns	Measured after 6 weeks	Digital foot pressure patterns and gait parameters of the participants walking on a gait mat.