Interface Kinematics of Transhumeral Prosthetic Sockets Using XROMM

Traumatic Amputation of Arm Clinical Trial

Official title:

Interface Kinematics of Transhumeral Prosthetic Sockets Using XROMM

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01546675
• Other study ID #: A9227-P
• Status: Completed
• Phase: N/A
• First received: February 27, 2012
• Last updated: November 17, 2014
• Start date: January 2012
• Est. completion date: September 2013

Study information

• Verified date: November 2014
• Source: VA Office of Research and Development
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2
• Est. completion date: September 2013
• Est. primary completion date: June 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Amputation, Traumatic
• Traumatic Amputation of Arm

Intervention

Other:
• Skeletal Stabilization
Upper Limb Prosthetic Socket hypothesized to increase skeletal stabilization

Locations

Country	Name	City	State
United States	Manhattan Campus of the VA NY Harbor Healthcare System, New York, NY	New York	New York
United States	Providence VA Medical Center, Providence, RI	Providence	Rhode Island

Sponsors (3)

Lead Sponsor	Collaborator
VA Office of Research and Development	Brown University, Lifespan

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	After 4 weeks of home use (2 weeks for each socket style)	No
Primary	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)	After 4 weeks of home use (2 weeks for each socket style)	No
Primary	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)	After 4 weeks of home use (2 weeks for each socket style)	No
Secondary	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.	After 4 weeks of home use (2 weeks for each socket style)	No
Secondary	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.	after 2 weeks of home use of each socket type	No
Secondary	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.	After 4 weeks of home use (2 weeks for each socket style)	No