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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: November 17, 2014
Last verified: November 2014
  Purpose

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.


Condition Intervention
Traumatic Amputation of Arm
Other: Skeletal Stabilization

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Interface Kinematics of Transhumeral Prosthetic Sockets Using XROMM

Further study details as provided by Department of Veterans Affairs:

Primary Outcome Measures:
  • Degrees of Shoulder Abduction Within the Prosthetic Socket [ Time Frame: After 4 weeks of home use (2 weeks for each socket style) ] [ Designated as safety issue: No ]
    Shoulder abduction was performed to the subject's maximum elevation. Skeletal and socket kinematics were calculated using the markerless auto-registration algorithm and X-Ray Reconstruction of Moving Morphology (XROMM)

  • Degrees of Shoulder Internal Rotation Within the Prosthetic Socket [ Time Frame: After 4 weeks of home use (2 weeks for each socket style) ] [ Designated as safety issue: No ]
    Isometric internal rotation was performed with the prosthetic elbow flexed to 90 degrees and shoulder in neutral position. Skeletal and socket kinematics were calculated using the markerless auto-registration algorithm and X-Ray Reconstruction of Moving Morphology (XROMM)

  • Degrees of Shoulder Displacement Within the Prosthetic Socket [ Time Frame: After 4 weeks of home use (2 weeks for each socket style) ] [ Designated as safety issue: No ]
    A shoulder shrug task was achieved by pulling up on a strap attached to the load cell, which was mounted on the vertical face of the concrete pedestal. Skeletal and socket kinematics were calculated using the markerless auto-registration algorithm and X-Ray Reconstruction of Moving Morphology (XROMM)


Secondary Outcome Measures:
  • Trinity Amputations and Prosthetics Experience Satisfaction Scale (TAPES) [ Time Frame: After 4 weeks of home use (2 weeks for each socket style) ] [ Designated as safety issue: No ]
    This 10 item scale includes items related to satisfaction with aspects of the prosthesis. It 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. Each item is rated on a 5 point scale from very dissatisfied to very satisfied. Scores are summed and the average of the 10 items are calculated. Higher scores indicate greater satisfaction. Scores range from 1-5.

  • Prosthetic Evaluation Questionnaire (PEQ) - Utility Subscale [ Time Frame: after 2 weeks of home use of each socket type ] [ Designated as safety issue: No ]
    The 8-item utility subscale includes items related to prosthetic socket utility including: comfort, fit, ease of donning and doffing and feel on the residual limb. All items were scored using a 1 to 7 Likert scale average with lower scores indicated worse ratings and higher scores indicated better ratings. The scores for each item were added and the total score was the average of scores for all items, thus scores could range from 1 to 7.

  • Prosthetic Evaluation Questionnaire (PEQ) - Residual Limb Health Subscale [ Time Frame: After 4 weeks of home use (2 weeks for each socket style) ] [ Designated as safety issue: No ]
    The 6-item residual limb health scale includes items about the bothersome of sweating, smell, swelling, ingrown hairs, rashes and blisters. All items were scored using a 1 to 7 Likert scale average with lower scores indicated worse ratings and higher scores indicated better ratings. The scores for each item were added and the total score was the average of scores for all items, thus scores could range from 1 to 7.


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)
Arms Assigned Interventions
Active Comparator: 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.
Other: Skeletal Stabilization
Upper Limb Prosthetic Socket hypothesized to increase skeletal stabilization
Other Name: Skeletal Stabilization Socket
Experimental: 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.
Other: Skeletal Stabilization
Upper Limb Prosthetic Socket hypothesized to increase skeletal stabilization
Other Name: 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 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
Results First Received: October 17, 2014
Last Updated: November 17, 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 November 23, 2014