Interface Kinematics of Transhumeral Prosthetic Sockets Using XROMM

This study has been completed.
Sponsor:
Collaborators:
Lifespan
Brown University
Information provided by (Responsible Party):
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT01546675
First received: February 27, 2012
Last updated: January 22, 2014
Last verified: January 2014
  Purpose

The purpose of this pilot study is 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 will include assessments of patient comfort and satisfaction with fit, as well as dynamic kinematic assessment using a novel high-speed, high-resolution, bi-plane video radiography system.


Condition Intervention
Traumatic Amputation of Arm
Other: Socket

Study Type: Observational
Study Design: Observational Model: Case-Crossover
Time Perspective: Prospective
Official Title: Interface Kinematics of Transhumeral Prosthetic Sockets Using XROMM

Resource links provided by NLM:


Further study details as provided by Department of Veterans Affairs:

Primary Outcome Measures:
  • X-Ray Reconstruction of Moving Morphology (XROMM) [ Time Frame: After 4 weeks of home use ] [ Designated as safety issue: No ]
    XROMM is a bi-plane videoradiography system designed to accurately measure 3-D in vivo skeletal kinematics. It will be used to examine motion of residual bone, soft tissue and socket.


Secondary Outcome Measures:
  • Trinity Amputations and Prosthetics Experience Satisfaction Scale (TAPES) [ Time Frame: after 2 weeks of home use of each socket type ] [ Designated as safety issue: No ]
    This is a 10 item scale related to prosthetic satisfaction which includes questions about extent of satisfaction regarding functional characteristics of the artificial limb: reliability, comfort, fit, and overall satisfaction, contentment with cosmetic characteristics of the device.

  • Prosthetic Evaluation Questionnaire (PEQ) [ Time Frame: after 2 weeks of home use of each socket type< ] [ Designated as safety issue: No ]
    The study will utilize 5 pertinent items from the PEQ related to: 1) temperature and texture of socket, 2) sweat inside socket, 3) sweat inside socket, 4) fit of prosthesis, 5) impact of swelling of residual limb on fit of prosthesis.


Estimated Enrollment: 2
Study Start Date: January 2012
Study Completion Date: September 2013
Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Group 1
Subjects will be fit with the Traditional Socket first, and then will be fit with socket design hypothesized to provide greater skeletal stabilization.
Other: Socket
Traditional Socket and Skeletal Stabilization socket
Group 2
Subjects will be fit with socket hypothesized to increase skeletal stabilization socket first, and then will be fit with the Traditional Socket.
Other: Socket
Traditional Socket and Skeletal Stabilization socket

Detailed Description:

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 is 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Male and female transhumeral amputees who are 18 years or older and who are current prosthetic users will be enrolled in this study.

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01546675

Locations
United States, New York
Manhattan Campus of the VA NY Harbor Healthcare System, New York, NY
New York, New York, United States, 10010
United States, Rhode Island
Providence VA Medical Center, Providence, RI
Providence, Rhode Island, United States, 02908
Sponsors and Collaborators
Lifespan
Brown University
Investigators
Principal Investigator: Linda J Resnik, PhD MS Providence VA Medical Center, Providence, RI
  More Information

No publications provided

Responsible Party: Department of Veterans Affairs
ClinicalTrials.gov Identifier: NCT01546675     History of Changes
Other Study ID Numbers: A9227-P
Study First Received: February 27, 2012
Last Updated: January 22, 2014
Health Authority: United States: Federal Government

Keywords provided by Department of Veterans Affairs:
Amputation
Prosthesis Design
Biomechanics

Additional relevant MeSH terms:
Amputation, Traumatic
Wounds and Injuries

ClinicalTrials.gov processed this record on September 30, 2014