Characterizing Ankle Function During Sloped Locomotion for Prosthesis Development

Traumatic Amputation of Lower Extremity Clinical Trial

Official title:

Characterizing Ankle Function During Sloped Locomotion for Prosthesis Development

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01784003
• Other study ID #: A7972W
• Status: Completed
• Start date: June 2012
• Est. completion date: September 2020

Study information

• Verified date: September 2020
• Source: VA Eastern Colorado Health Care System
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The proposed study aims to characterize biological ankle joint function during walking and running on slopes in order to further develop advanced powered ankle-foot prostheses. Ankle joint torque and angle data will be collected from non-amputees while walking and running at multiple speeds and slopes. This data will be used to develop control parameters for a powered ankle-foot prosthesis. Then, these parameters will be implemented and tested in a powered prosthesis worn by people with below the knee amputations.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: September 2020
• Est. primary completion date: September 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 45 Years

Eligibility

Inclusion Criteria:

Study 1:

• Between 18-60 years old.

Study 2 and 3:

• Between 18-60 years old.

• At least 1 year post-amputation

• no current problems with prosthesis or residual limb

• At least a K3 level of ambulation

Study 4:

• Between 18-45 years old

Study 5:

• Between 18-45 years old

• At least 1 year post-amputation

• no current problems with prosthesis or residual limb

• Experience running with a passive prosthesis

• At least a K4 level of ambulation

Exclusion Criteria:

Studies 1-5

• Cardiovascular, pulmonary, or neurological disease or disorder

• Musculoskeletal injury

Related Conditions & MeSH terms

• Amputation, Traumatic
• Traumatic Amputation of Lower Extremity

Intervention

Device:
• Powered ankle-foot prosthesis

Locations

Country	Name	City	State
United States	University of Colorado Boulder	Boulder	Colorado

Sponsors (1)

Lead Sponsor	Collaborator
VA Eastern Colorado Health Care System

Country where clinical trial is conducted

United States, 

References & Publications (6)

Jeffers JR, Auyang AG, Grabowski AM. The correlation between metabolic and individual leg mechanical power during walking at different slopes and velocities. J Biomech. 2015 Aug 20;48(11):2919-24. doi: 10.1016/j.jbiomech.2015.04.023. Epub 2015 Apr 22. — View Citation

Jeffers JR, Grabowski AM. Individual Leg and Joint Work during Sloped Walking for People with a Transtibial Amputation Using Passive and Powered Prostheses. Front. Robot. AI, 22 December 2017. https://doi.org/10.3389/frobt.2017.00072

Montgomery JR, Grabowski AM. The contributions of ankle, knee and hip joint work to individual leg work change during uphill and downhill walking over a range of speeds. R Soc Open Sci. 2018 Aug 29;5(8):180550. doi: 10.1098/rsos.180550. eCollection 2018 A — View Citation

Montgomery JR, Grabowski AM. Use of a powered ankle-foot prosthesis reduces the metabolic cost of uphill walking and improves leg work symmetry in people with transtibial amputations. J R Soc Interface. 2018 Aug;15(145). pii: 20180442. doi: 10.1098/rsif.2 — View Citation

Pickle NT, Grabowski AM, Auyang AG, Silverman AK. The functional roles of muscles during sloped walking. J Biomech. 2016 Oct 3;49(14):3244-3251. doi: 10.1016/j.jbiomech.2016.08.004. Epub 2016 Aug 6. — View Citation

Pickle NT, Grabowski AM, Jeffers JR, Silverman AK. The Functional Roles of Muscles, Passive Prostheses, and Powered Prostheses During Sloped Walking in People With a Transtibial Amputation. J Biomech Eng. 2017 Nov 1;139(11). doi: 10.1115/1.4037938. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Force-measuring treadmill and motion capture		approximately 2 months
Primary	Metabolic analysis system		approximately 2 months