search
Back to results

Interface Kinematics of Transhumeral Prosthetic Sockets Using XROMM

Primary Purpose

Traumatic Amputation of Arm

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Skeletal Stabilization
Sponsored by
US Department of Veterans Affairs
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Traumatic Amputation of Arm focused on measuring Amputation, Prosthesis Design, Biomechanics

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Manhattan Campus of the VA NY Harbor Healthcare System, New York, NY
  • Providence VA Medical Center, Providence, RI

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Traditional 1, Skeletal Stabilization 2

Skeletal Stabilization 1, Traditional 2

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Degrees of Shoulder Abduction Within the Prosthetic Socket
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
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
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)
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
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
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.

Full Information

First Posted
February 27, 2012
Last Updated
November 17, 2014
Sponsor
US Department of Veterans Affairs
Collaborators
Lifespan, Brown University
search

1. Study Identification

Unique Protocol Identification Number
NCT01546675
Brief Title
Interface Kinematics of Transhumeral Prosthetic Sockets Using XROMM
Official Title
Interface Kinematics of Transhumeral Prosthetic Sockets Using XROMM
Study Type
Interventional

2. Study Status

Record Verification Date
November 2014
Overall Recruitment Status
Completed
Study Start Date
January 2012 (undefined)
Primary Completion Date
June 2013 (Actual)
Study Completion Date
September 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
US Department of Veterans Affairs
Collaborators
Lifespan, Brown University

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Traumatic Amputation of Arm
Keywords
Amputation, Prosthesis Design, Biomechanics

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
2 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Traditional 1, Skeletal Stabilization 2
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Skeletal Stabilization 1, Traditional 2
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Skeletal Stabilization
Other Intervention Name(s)
Skeletal Stabilization Socket
Intervention Description
Upper Limb Prosthetic Socket hypothesized to increase skeletal stabilization
Primary Outcome Measure Information:
Title
Degrees of Shoulder Abduction Within the Prosthetic Socket
Description
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)
Time Frame
After 4 weeks of home use (2 weeks for each socket style)
Title
Degrees of Shoulder Internal Rotation Within the Prosthetic Socket
Description
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)
Time Frame
After 4 weeks of home use (2 weeks for each socket style)
Title
Degrees of Shoulder Displacement Within the Prosthetic Socket
Description
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)
Time Frame
After 4 weeks of home use (2 weeks for each socket style)
Secondary Outcome Measure Information:
Title
Trinity Amputations and Prosthetics Experience Satisfaction Scale (TAPES)
Description
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.
Time Frame
After 4 weeks of home use (2 weeks for each socket style)
Title
Prosthetic Evaluation Questionnaire (PEQ) - Utility Subscale
Description
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.
Time Frame
after 2 weeks of home use of each socket type
Title
Prosthetic Evaluation Questionnaire (PEQ) - Residual Limb Health Subscale
Description
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.
Time Frame
After 4 weeks of home use (2 weeks for each socket style)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Linda J Resnik, PhD MS
Organizational Affiliation
Providence VA Medical Center, Providence, RI
Official's Role
Principal Investigator
Facility Information:
Facility Name
Manhattan Campus of the VA NY Harbor Healthcare System, New York, NY
City
New York
State/Province
New York
ZIP/Postal Code
10010
Country
United States
Facility Name
Providence VA Medical Center, Providence, RI
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02908
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
25425411
Citation
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.
Results Reference
derived

Learn more about this trial

Interface Kinematics of Transhumeral Prosthetic Sockets Using XROMM

We'll reach out to this number within 24 hrs