Clinical trial NCT01546675: Interface Kinematics of Transhumeral Prosthetic Sockets Using XROMM
Official title: Interface Kinematics of Transhumeral Prosthetic Sockets Using XROMM
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Traumatic Amputation of Arm
Keywords: Amputation
Prosthesis Design
Biomechanics
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
Collaborators: name: Lifespan
name: Brown University
First posted: 2012-03-07
Enrollment: 2
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Degrees of Shoulder Abduction Within the Prosthetic Socket
timeFrame: After 4 weeks of home use (2 weeks for each socket style)
measure: Degrees of Shoulder Internal Rotation Within the Prosthetic Socket
timeFrame: After 4 weeks of home use (2 weeks for each socket style)
measure: Degrees of Shoulder Displacement Within the Prosthetic Socket
timeFrame: After 4 weeks of home use (2 weeks for each socket style)
Secondary outcomes:
measure: Trinity Amputations and Prosthetics Experience Satisfaction Scale (TAPES)
timeFrame: After 4 weeks of home use (2 weeks for each socket style)
measure: Prosthetic Evaluation Questionnaire (PEQ) - Utility Subscale
timeFrame: after 2 weeks of home use of each socket type
measure: Prosthetic Evaluation Questionnaire (PEQ) - Residual Limb Health Subscale
timeFrame: After 4 weeks of home use (2 weeks for each socket style)
Other outcomes:
Locations:
city: New York
country: United States
facility: Manhattan Campus of the VA NY Harbor Healthcare System, New York, NY
state: New York
city: Providence
country: United States
facility: Providence VA Medical Center, Providence, RI
state: Rhode Island
Study officials:
affiliation: Providence VA Medical Center, Providence, RI
name: Linda J Resnik, PhD MS
role: PRINCIPAL_INVESTIGATOR
References:
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.