A Comparison of External Mechanical Work Between Different Prosthetic Feet

NCT01340807 | Completed DMC

• 2 other identifiers: 8497.0101
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

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?

Conditions

Traumatic Amputation of Lower Extremity

Outcome Measures

Primary Outcomes (1)

• Symmetry in External Work

  Work done by the intact and prosthetic limb

  up to 12 weeks

Secondary Outcomes (1)

• Self Report and Performance Based Assessment Instruments

  up to 12 weeks

Study Arms (1)

Prosthetic Feet

EXPERIMENTAL

Randomized to 4 different prosthetic feet (SACH, SAFE, TALUX, and Proprio Foot)

Other: Specialized Functional Prosthetic Training

Interventions

Specialized Functional Prosthetic Training OTHER

Each subject receives specialized functional prosthetic training

Also known as: Proshetic Feet

Prosthetic Feet

Eligibility Criteria

• Age: 40 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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

Sponsors & Collaborators

• Miami VA Healthcare System: lead

Study Sites (1)

Miami VAHS

Miami, Florida, 33155, United States

Location

Study Officials

• Ronald Tolchin, DO

  Miami VAHS

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: FED

Study Record Dates

• First Submitted: April 19, 2011
• First Posted: April 25, 2011
• Study Start: March 1, 2008
• Primary Completion: January 1, 2010
• Study Completion: January 1, 2011
• Last Updated: April 25, 2011

Record last verified: 2011-02

Locations

US (1)