- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01340807
A Comparison of External Mechanical Work Between Different Prosthetic Feet (SEW)
A Comparison of External Mechanical Work Between Bionic and Conventional Prosthetic Feet in Transtibial Amputees During Functional Activities
Recent dysvascular and diabetic amputees as well as older, long-term traumatic amputees are at risk of functional decline, joint degeneration, skin breakdown and further limb loss due to the forces placed on the contralateral limb through prosthetic ambulation. If specialized prosthetic gait training and proper use of the appropriate prosthetic foot can decrease forces on the intact limb, the long term health and quality of life of veterans with amputations could be substantially improved. We will address two key questions:
Key Question 1: After receiving specialized gait training and a new prosthetic socket, will subjects demonstrate differences in gait symmetry and external mechanical work between the bionic and conventional prosthetic feet, while performing various functional activities.
Key Question 2: Can external mechanical work be used as a clinically friendly measure to differentiate between prosthetic feet?
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Florida
-
Miami, Florida, United States, 33155
- Miami VAHS
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
Males and/or Females between the ages of 40 and 65. b. People with unilateral transtibial amputations for vascular reasons or from traumatic events.
c. At the lowest level of function candidates will have the ability to use a prosthesis for ambulation on level surfaces at a fixed cadence.
d. People with a diagnosis of diabetes mellitus and/or peripheral vascular disease leading to amputation or people who have been amputated as a result of trauma.
e. People comfortably fitted with a prosthesis for a period of at least 6 months.
f. Candidates who score within the range of 29 to 47 on the Amputee Mobility Predictor which would indicate that subjects achieved the minimum required score to be fitted with a prosthesis.
g. Able to tolerate the testing protocol and would not fatigue at any time during testing.
h. Men's shoe size should be between 7.5 (25 cm) and 12.5 (29 cm). i. Women's shoe size should be between 8.5 (25 cm) and 13.5 (29 cm).
Exclusion Criteria:
People who weigh more than 255 pounds at baseline visit. People receiving renal dialysis b. People with severe cardiac or pulmonary disease limiting ability to exercise including angina or poorly controlled hypertension.
c. People with neurological disorder such as or stroke that affecting ability to ambulate d. People with severe lower limb arthritis e. People with wound on non-amputated side f. People experiencing problems with prosthetic fit g. People with poor control of diabetes
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Prosthetic Feet
Randomized to 4 different prosthetic feet (SACH, SAFE, TALUX, and Proprio Foot)
|
Each subject receives specialized functional prosthetic training
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Symmetry in External Work
Time Frame: up to 12 weeks
|
Work done by the intact and prosthetic limb
|
up to 12 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Self Report and Performance Based Assessment Instruments
Time Frame: up to 12 weeks
|
PEQ-13, LCI-5, AMPPRO, 6MWT, and SAM.
|
up to 12 weeks
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Ronald Tolchin, DO, Miami VAHS
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 8497.01
- 01 (Miami VAHS)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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