Interface Kinematics of Transhumeral Prosthetic Sockets Using XROMM
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
The purpose of this pilot study is 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 will include assessments of patient comfort and satisfaction with fit, as well as dynamic kinematic assessment using a novel high-speed, high-resolution, bi-plane video radiography system.
| Condition | Intervention |
|---|---|
|
Traumatic Amputation of Arm |
Other: Socket |
| Study Type: | Observational |
| Study Design: | Observational Model: Case-Crossover Time Perspective: Prospective |
| Official Title: | Interface Kinematics of Transhumeral Prosthetic Sockets Using XROMM |
- X-Ray Reconstruction of Moving Morphology (XROMM) [ Time Frame: After 4 weeks of home use ] [ Designated as safety issue: No ]XROMM is a bi-plane videoradiography system designed to accurately measure 3-D in vivo skeletal kinematics. It will be used to examine motion of residual bone, soft tissue and socket.
- Trinity Amputations and Prosthetics Experience Satisfaction Scale (TAPES) [ Time Frame: after 2 weeks of home use of each socket type ] [ Designated as safety issue: No ]This is a 10 item scale related to prosthetic satisfaction which 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.
- Prosthetic Evaluation Questionnaire (PEQ) [ Time Frame: after 2 weeks of home use of each socket type< ] [ Designated as safety issue: No ]The study will utilize 5 pertinent items from the PEQ related to: 1) temperature and texture of socket, 2) sweat inside socket, 3) sweat inside socket, 4) fit of prosthesis, 5) impact of swelling of residual limb on fit of prosthesis.
| Estimated Enrollment: | 2 |
| Study Start Date: | January 2012 |
| Estimated Study Completion Date: | September 2013 |
| Estimated Primary Completion Date: | June 2013 (Final data collection date for primary outcome measure) |
| Groups/Cohorts | Assigned Interventions |
|---|---|
|
Group 1
Subjects will be fit with the Traditional Socket first, and then will be fit with socket design hypothesized to provide greater skeletal stabilization.
|
Other: Socket
Traditional Socket and Skeletal Stabilization socket
|
|
Group 2
Subjects will be fit with socket hypothesized to increase skeletal stabilization socket first, and then will be fit with the Traditional Socket.
|
Other: Socket
Traditional Socket and 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 is 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 |
| Sampling Method: | Non-Probability Sample |
Male and female transhumeral amputees who are 18 years or older and who are current prosthetic users will be enrolled in this study.
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| Contact: Kate J Barnabe, MHA | (401) 273-7100 ext 6272 | Kate.Barnabe@va.gov |
| Contact: Susan Rizzo | (401) 273-7100 | Susan.Rizzo2@va.gov |
| United States, New York | |
| Manhattan Campus of the VA NY Harbor Healthcare System, New York, NY | Recruiting |
| New York, New York, United States, 10010 | |
| Contact: MaryAnne Garbarini, MPT 212-951-3339 maryanne.garbarini@va.gov | |
| United States, Rhode Island | |
| Providence VA Medical Center, Providence, RI | Recruiting |
| Providence, Rhode Island, United States, 02908 | |
| Contact: Kate J Barnabe, MHA 401-273-7100 ext 6272 Kate.Barnabe@va.gov | |
| Contact: Susan Rizzo (401) 273-7100 Susan.Rizzo2@va.gov | |
| Principal Investigator: Linda J Resnik, PhD MS | |
| 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 |
| Last Updated: | March 19, 2013 |
| 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 May 22, 2013