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Interface Kinematics of Transhumeral Prosthetic Sockets Using XROMM

NCT ID: NCT01546675

Last Updated: 2014-11-24

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

2 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-01-31

Study Completion Date

2013-09-30

Brief Summary

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The purpose of this pilot study was to conduct a head-to-head comparison of two designs for transhumeral level upper limb prosthetic sockets: a traditional socket design and a socket design hypothesized to provide greater skeletal stabilization. The investigators comparisons included assessments of patient comfort and satisfaction with fit, as well as dynamic kinematic assessment using X-Ray Reconstruction of Moving Morphology (XROMM) a novel high-speed, high-resolution, bi-plane video radiography system.

Detailed Description

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In the past decade, advances in upper limb socket design and technology have been proposed to increase comfort and decrease perceived weight of the prosthesis. There have been no scientific studies to date that have evaluated the benefits of these designs, and thus no evidence to support use of one type of prosthetic socket design over another. Thus, the overall purpose of this pilot study was to conduct a head-to-head comparison of two designs for transhumeral level upper limb prosthetic sockets: a traditional socket design and a socket design hypothesized to provide greater skeletal stabilization.

Conditions

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Traumatic Amputation of Arm

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Traditional 1, Skeletal Stabilization 2

Subjects using the Traditional Socket and socket hypothesized to increase skeletal stabilization in a case cross-over design. The intervention is the socket designed to increase skeletal stabilization.

Group Type ACTIVE_COMPARATOR

Skeletal Stabilization

Intervention Type OTHER

Upper Limb Prosthetic Socket hypothesized to increase skeletal stabilization

Skeletal Stabilization 1, Traditional 2

Subjects using the socket hypothesized to increase skeletal stabilization and Traditional Socket and in a case cross-over design. The intervention is the socket designed to increase skeletal stabilization.

Group Type EXPERIMENTAL

Skeletal Stabilization

Intervention Type OTHER

Upper Limb Prosthetic Socket hypothesized to increase skeletal stabilization

Interventions

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Skeletal Stabilization

Upper Limb Prosthetic Socket hypothesized to increase skeletal stabilization

Intervention Type OTHER

Other Intervention Names

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Skeletal Stabilization Socket

Eligibility Criteria

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Inclusion Criteria

* Male and female transhumeral amputees, 18 years or older of any ethnicity, who are current prosthetic users.

Exclusion Criteria

* Subjects with frozen shoulder of the residual side, and/or severely limited active range of motion of the shoulder joint of the residual limb
* Inability to tolerate wearing of a prosthetic socket
* Mental impairment that renders a subject unable to comply with the study
* Skin conditions such as burns or poor skin coverage as well as those with severe contractures that prevent prior prosthetic wear
* Any electrically controlled medical device including pacemaker, implanted defibrillator or drug pumps
* Neuropathy, uncontrolled diabetes, receiving dialysis
* Any other significant comorbidity which would interfere with the study
* Severe circulatory problems including peripheral vascular disease and pitting edema will be excluded
* Cognitive deficits or mental health problems that would limit ability to participate fully in the study protocol
* Women who are pregnant or who plan to become pregnant in the near future
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Lifespan

OTHER

Sponsor Role collaborator

Brown University

OTHER

Sponsor Role collaborator

US Department of Veterans Affairs

FED

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Linda J Resnik, PhD MS

Role: PRINCIPAL_INVESTIGATOR

Providence VA Medical Center, Providence, RI

Locations

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Manhattan Campus of the VA NY Harbor Healthcare System, New York, NY

New York, New York, United States

Site Status

Providence VA Medical Center, Providence, RI

Providence, Rhode Island, United States

Site Status

Countries

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United States

References

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Resnik L, Patel T, Cooney SG, Crisco JJ, Fantini C. Comparison of transhumeral socket designs utilizing patient assessment and in vivo skeletal and socket motion tracking: a case study. Disabil Rehabil Assist Technol. 2016;11(5):423-32. doi: 10.3109/17483107.2014.981876. Epub 2014 Nov 26.

Reference Type DERIVED
PMID: 25425411 (View on PubMed)

Other Identifiers

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A9227-P

Identifier Type: -

Identifier Source: org_study_id