Comparison of Prosthetic Feet for the Geriatric Patients(CPF)

Loewenstein Hospital

Status: Unknown

Conditions: Amputation

Treatments: Device: SACH prosthetic foot, 1M10 prosthetic foot

Study type: Interventional

Funder types: Other

Identifiers

NCT03249883

0027-14-LOE

Details and patient eligibility

About

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.

Full 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.

Enrollment: 14 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• unilateral transtibial amputees
• limited ambulators

Exclusion criteria

• do not speak Hebrew
• are not cognitively intact

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Triple Blind

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14 participants in 2 patient groups

SACH first

Active Comparator group

Description:

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

Treatment:

Device: SACH prosthetic foot, 1M10 prosthetic foot

1M10 first

Active Comparator group

Description:

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

Treatment:

Device: SACH prosthetic foot, 1M10 prosthetic foot