Characterizing Ankle Function During Sloped Locomotion for Prosthesis Development

NCT ID: NCT01784003

Last Updated: 2020-09-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

60 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-06-30

Study Completion Date

2020-09-30

Brief Summary

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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.

Detailed Description

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Conditions

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Traumatic Amputation of Lower Extremity

Study Design

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Observational Model Type

OTHER

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Non-amputee

People without an amputation will be recruited to participate in the study.

No interventions assigned to this group

Below the knee amputee

People with a unilateral transtibial amputation will be recruited to participate in the study.

Powered ankle-foot prosthesis

Intervention Type DEVICE

Interventions

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Powered ankle-foot prosthesis

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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VA Eastern Colorado Health Care System

FED

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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University of Colorado Boulder

Boulder, Colorado, United States

Site Status

Countries

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United States

References

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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.

Reference Type RESULT
PMID: 25959113 (View on PubMed)

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 Aug.

Reference Type RESULT
PMID: 30225047 (View on PubMed)

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):1110051-11100511. doi: 10.1115/1.4037938.

Reference Type RESULT
PMID: 28975280 (View on PubMed)

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.

Reference Type RESULT
PMID: 27553849 (View on PubMed)

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):20180442. doi: 10.1098/rsif.2018.0442.

Reference Type RESULT
PMID: 30158189 (View on PubMed)

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

Reference Type RESULT

Other Identifiers

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A7972W

Identifier Type: -

Identifier Source: org_study_id

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