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Comparison of Prosthetic Feet for the Geriatric Patients(CPF) (CPF)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03249883
Recruitment Status : Unknown
Verified June 2017 by Loewenstein Hospital.
Recruitment status was:  Not yet recruiting
First Posted : August 15, 2017
Last Update Posted : August 15, 2017
Sponsor:
Collaborator:
Tel Aviv University
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Amputation Device: SACH prosthetic foot, 1M10 prosthetic foot Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 14 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Evaluation of a Geriatric Foot- 1M10 ADJUST Versus the Solid Ankle Cushioned Heel Foot for Low Activity Amputees
Estimated Study Start Date : September 1, 2017
Estimated Primary Completion Date : October 2018
Estimated Study Completion Date : March 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: SACH first
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

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.


Active Comparator: 1M10 first
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

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.





Primary Outcome Measures :
  1. Prosthetic satisfaction Questionnaire [ Time Frame: Measured after 3 weeks ]
    Hebrew satisfaction questionnaire

  2. 10 meter walk test [ Time Frame: 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

  3. Get up and go test [ Time Frame: 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.

  4. Prosthetic Satisfaction Questionnaire [ Time Frame: Measured after 6 weeks ]
    Hebrew satisfaction questionnaire

  5. 10 meter walk test [ Time Frame: 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

  6. Get up and go test [ Time Frame: 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


Secondary Outcome Measures :
  1. Gait patterns [ Time Frame: Measured after 3 weeks and ]
    Digital foot pressure patterns and gait parameters of the participants walking on a gait mat.

  2. Gait patterns [ Time Frame: Measured after 6 weeks ]
    Digital foot pressure patterns and gait parameters of the participants walking on a gait mat.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • unilateral transtibial amputees
  • limited ambulators

Exclusion Criteria:

  • do not speak Hebrew
  • are not cognitively intact

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03249883


Contacts
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Contact: Hagay Amir, MD 972-50-6263379 hagayam@clalit.org.il

Sponsors and Collaborators
Loewenstein Hospital
Tel Aviv University
Investigators
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Principal Investigator: Hagay Amir, MD Director of Orthopedic rehabilitation Department
Publications of Results:
Hansen A, Sam M, Childress D. The effective foot length ratio: a potential tool for characterization and eval¬uation of prosthetic feet. J Prosthet Orthot 2004; 16(2): 41-45.

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Responsible Party: Loewenstein Hospital
ClinicalTrials.gov Identifier: NCT03249883    
Other Study ID Numbers: 0027-14-LOE
First Posted: August 15, 2017    Key Record Dates
Last Update Posted: August 15, 2017
Last Verified: June 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Loewenstein Hospital:
prosthetic feet
double blind study
limited ambulators
SACH foot
prosthetic components comparison