Metabolic Cost Savings for Transtibial Amputees Wearing the Controlled Energy Storage and Return (CESR) Foot

NCT00494143 | Completed Phase 3 Results

• 1 other identifier: A4372-R
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 1

Brief Summary

To determine if below-knee amputees will walk with better efficiency wearing a CESR foot which stores energy at heel strike and releases energy releases energy during push-off.

Conditions

Transtibial Amputation

Keywords

Amputee; Economy; Efficiency; Foot; Gait; Kinematics; Kinetics; Prosthesis

Outcome Measures

Primary Outcomes (1)

• Metabolic Oxygen Consumption During Ambulation

  VO2 was collected at rest and while walking at a controlled walking speed of 1.14 meters/second for 10 minutes until they reached a steady state for 3 minutes. This was repeated for each foot condition. VO2 at the steady state was recorded in ml/min and were subsequently converted to calories and and then to Watts. The data were then corrected for body weight by dividing by weight in Kg. The gross VO2 in Watts/Kg during walking were then adjusted to net VO2 in Watts/kg by subtracting the resting metabolic rate.

  Subjects were oriented to the testing protocol and each prosthetic foot on average 5 days prior to data collection and a acclimatization period of 5-10 minutes with each prosthetic foot prior to data collection

Secondary Outcomes (2)

• Prosthetic Foot Push Off Peak Power

  Subjects were oriented to the testing protocol and each prosthetic foot on average 5 days prior to data collection and a acclimatization period of 5-10 minutes with each prosthetic foot prior to data collection

• Peak Intact Knee Loading

  Subjects were oriented to the testing protocol and each prosthetic foot on average 5 days prior to data collection and a acclimatization period of 5-10 minutes with each prosthetic foot prior to data collection

Study Arms (3)

Conventional Prosthetic foot

ACTIVE COMPARATOR

A conventional prosthetic foot that has limited energy storage and return capabilities. It is standardized and used by all subjects in the study.

Device: typical prosthetic foot

Prescribed Prosthetic foot

ACTIVE COMPARATOR

the Prosthetic foot that the subject had prescribed for them by their clinical providers and was worn prior to study initiation

Device: standardized prosthetic foot

CESR foot

EXPERIMENTAL

the experimental CESR, controlled energy storage prosthetic foot

Device: CESR Prosthetic Foot

Interventions

CESR Prosthetic Foot DEVICE

a novel prosthetic foot that is designed to store energy and release it at a predetermined time in the gait cycle

CESR foot

typical prosthetic foot DEVICE

patients will wear the prosthetic foot that they were prescribed by the care providers in the clinical team

Conventional Prosthetic foot

standardized prosthetic foot DEVICE

a standard foot that has had weights applied to match the mass of the CESR foot

Prescribed Prosthetic foot

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Transtibial Amputees \> 1 year walking with prosthesis
• Non-amputee control subjects

You may not qualify if:

• Additional musculoskeletal pathology
• Cognitive limitation

Sponsors & Collaborators

• US Department of Veterans Affairs: lead
• University of Michigan: collaborator

Study Sites (1)

VA Puget Sound Health Care System, Seattle

Seattle, Washington, 98108, United States

Location

Related Publications (3)

• Segal AD, Zelik KE, Klute GK, Morgenroth DC, Hahn ME, Orendurff MS, Adamczyk PG, Collins SH, Kuo AD, Czerniecki JM. The effects of a controlled energy storage and return prototype prosthetic foot on transtibial amputee ambulation. Hum Mov Sci. 2012 Aug;31(4):918-31. doi: 10.1016/j.humov.2011.08.005. Epub 2011 Nov 17.

  PMID: 22100728 RESULT

• Morgenroth DC, Segal AD, Zelik KE, Czerniecki JM, Klute GK, Adamczyk PG, Orendurff MS, Hahn ME, Collins SH, Kuo AD. The effect of prosthetic foot push-off on mechanical loading associated with knee osteoarthritis in lower extremity amputees. Gait Posture. 2011 Oct;34(4):502-7. doi: 10.1016/j.gaitpost.2011.07.001. Epub 2011 Jul 30.

  PMID: 21803584 RESULT

• Zelik KE, Collins SH, Adamczyk PG, Segal AD, Klute GK, Morgenroth DC, Hahn ME, Orendurff MS, Czerniecki JM, Kuo AD. Systematic variation of prosthetic foot spring affects center-of-mass mechanics and metabolic cost during walking. IEEE Trans Neural Syst Rehabil Eng. 2011 Aug;19(4):411-9. doi: 10.1109/TNSRE.2011.2159018. Epub 2011 Jun 23.

  PMID: 21708509 RESULT

Limitations and Caveats

Acclimatization to a prosthetic foot type can alter the measured performance. In this study, subjects were most experienced using their prescribed foot. The CESR foot was also only available in one foot size which can affect gait characteristics.

Results Point of Contact

• Title: Dr. Joseph Czerniecki
• Organization: VA Puget Sound Health Care System

joseph.czerniecki@va.gov

206 277 5188

Study Officials

• Joseph M. Czernieki, MD MS

  VA Puget Sound Health Care System, Seattle

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 28, 2007
• First Posted: June 29, 2007
• Study Start: July 1, 2007
• Primary Completion: May 1, 2009
• Study Completion: December 1, 2012
• Last Updated: June 9, 2014
• Results First Posted: June 9, 2014

Record last verified: 2014-05

Locations

US (1)