Interface Kinematics of Transhumeral Prosthetic Sockets Using XROMM

• ClinicalTrials.gov Identifier: NCT01546675
• Recruitment Status: Completed
• First Posted: March 7, 2012
• Results First Posted: November 24, 2014
• Last Update Posted: November 24, 2014
• Sponsor: US Department of Veterans Affairs
• Collaborators: Lifespan; Brown University
• Information provided by (Responsible Party): VA Office of Research and Development ( US Department of Veterans Affairs )

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.

Condition or disease	Intervention/treatment	Phase
Traumatic Amputation of Arm	Other: Skeletal Stabilization	Not Applicable

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 2 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Interface Kinematics of Transhumeral Prosthetic Sockets Using XROMM
• Study Start Date: January 2012
• Actual Primary Completion Date: June 2013
• Actual Study Completion Date: September 2013

Arms and Interventions

Arm	Intervention/treatment
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

Outcome Measures

Primary Outcome Measures :

1. Degrees of Shoulder Abduction Within the Prosthetic Socket [ Time Frame: After 4 weeks of home use (2 weeks for each socket style) ]
   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)
2. Degrees of Shoulder Internal Rotation Within the Prosthetic Socket [ Time Frame: After 4 weeks of home use (2 weeks for each socket style) ]
   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)
3. Degrees of Shoulder Displacement Within the Prosthetic Socket [ Time Frame: After 4 weeks of home use (2 weeks for each socket style) ]
   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 :

1. Trinity Amputations and Prosthetics Experience Satisfaction Scale (TAPES) [ Time Frame: After 4 weeks of home use (2 weeks for each socket style) ]
   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.
2. Prosthetic Evaluation Questionnaire (PEQ) - Utility Subscale [ Time Frame: after 2 weeks of home use of each socket type ]
   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.
3. Prosthetic Evaluation Questionnaire (PEQ) - Residual Limb Health Subscale [ Time Frame: After 4 weeks of home use (2 weeks for each socket style) ]
   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.

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• 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

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

US Department of Veterans Affairs

Lifespan

Brown University

Investigators

• Principal Investigator: Linda J Resnik, PhD MS; Providence VA Medical Center, Providence, RI

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

• Responsible Party: US Department of Veterans Affairs
• ClinicalTrials.gov Identifier: NCT01546675
• Other Study ID Numbers: A9227-P
• First Posted: March 7, 2012
• Results First Posted: November 24, 2014
• Last Update Posted: November 24, 2014
• Last Verified: November 2014

Keywords provided by VA Office of Research and Development ( US Department of Veterans Affairs ):

Amputation; Prosthesis Design; Biomechanics

Additional relevant MeSH terms:

Amputation, Traumatic; Wounds and Injuries