Traumatic Amputation of ArmNCT01546675
Interface Kinematics of Transhumeral Prosthetic Sockets Using XROMM
A study testing Skeletal Stabilization in people with Traumatic Amputation of Arm, run by US Department of Veterans Affairs at 2 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Traumatic Amputation of Arm
- What is being tested?
- Skeletal Stabilization
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- 2 sitesUnited States
- Study dates
- Jan 2012to Sep 2013
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male and female transhumeral amputees, 18 years or older of any ethnicity, who are current prosthetic users.
Who cannot join
- 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
Show all 10Show fewer
- 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
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Manhattan Campus of the VA NY Harbor Healthcare System, New York, NY
New York, New York, 10010
Providence VA Medical Center, Providence, RI
Providence, Rhode Island, 02908
About this study
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.
Read the 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.
- Conditions
- Traumatic Amputation of Arm
- Being tested
- Skeletal Stabilization
- Keywords
- Amputation, Prosthesis Design, Biomechanics
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Skeletal StabilizationOther
Also called Skeletal Stabilization Socket
Upper Limb Prosthetic Socket hypothesized to increase skeletal stabilization
| Study group | Role | What they receive |
|---|---|---|
| Traditional 1, Skeletal Stabilization 2 | Active comparator | 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. Receives: Other: Skeletal Stabilization |
| Skeletal Stabilization 1, Traditional 2 | Experimental | 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. Receives: Other: Skeletal Stabilization |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: After 4 weeks of home use (2 weeks for each socket style)
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)
Measured: After 4 weeks of home use (2 weeks for each socket style)
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)
Measured: After 4 weeks of home use (2 weeks for each socket style)
Secondary outcomes (3)
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.
Measured: After 4 weeks of home use (2 weeks for each socket style)
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.
Measured: after 2 weeks of home use of each socket type
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.
Measured: After 4 weeks of home use (2 weeks for each socket style)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2012 (estimated)
- Study startJan 2012
- Primary completionJun 2013
- Study completionSep 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Traumatic Amputation of ArmStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- US Department of Veterans Affairs
- Sponsor type
- US federal agency
- Collaborators
- Lifespan, Brown University
- Responsible party
- Sponsor
- Investigators
- Linda J Resnik, PhD MS, Principal investigator, Providence VA Medical Center, Providence, RI
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01546675
- Sponsor's protocol ID
- A9227-P
- Status last verified
- Nov 2014
- First submitted
- 27 Feb 2012
- Last updated
- 24 Nov 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
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.
PubMed 25425411
Study at a glance
From the registry record, last updated by the sponsor on 24 Nov 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Interface Kinematics of Transhumeral Prosthetic Sockets Using XROMM
- ClinicalTrials.gov ID
- NCT01546675
- Acronym / sponsor ID
- A9227-P
- Conditions
- Traumatic Amputation of Arm
- Keywords
- Amputation, Prosthesis Design, Biomechanics
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2 participants (actual)
- Lead sponsor
- US Department of Veterans AffairsUS federal agency
- Collaborators
- Lifespan, Brown University
- Study start
- Jan 2012
- Primary completion
- Jun 2013 (actual)
- Study completion
- Sep 2013 (actual)
- First posted
- 7 Mar 2012 (estimated)
- Results
- Posted 24 Nov 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Traditional 1, Skeletal Stabilization 2 | Active comparator | Other: Skeletal StabilizationSubjects 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. |
| Skeletal Stabilization 1, Traditional 2 | Experimental | Other: Skeletal StabilizationSubjects 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Male and female transhumeral amputees, 18 years or older of any ethnicity, who are current prosthetic users.
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Skeletal StabilizationAlso: Skeletal Stabilization SocketUpper Limb Prosthetic Socket hypothesized to increase skeletal stabilization | Other | Skeletal Stabilization 1, Traditional 2, Traditional 1, Skeletal Stabilization 2 |
Primary outcome
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)
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)
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)
3 secondary outcomes
Trinity Amputations and Prosthetics Experience Satisfaction Scale (TAPES)
Time frame: After 4 weeks of home use (2 weeks for each socket style)
Prosthetic Evaluation Questionnaire (PEQ) - Utility Subscale
Time frame: after 2 weeks of home use of each socket type
Prosthetic Evaluation Questionnaire (PEQ) - Residual Limb Health Subscale
Time frame: After 4 weeks of home use (2 weeks for each socket style)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Nov 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 25425411Resnik 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Linda J Resnik, PhD MS principal investigator
Providence VA Medical Center, Providence, RI
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Skeletal Stabilization in people with Traumatic Amputation of Arm, run by US Department of Veterans Affairs at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Nov 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 24 Nov 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Degrees of Shoulder Abduction Within the Prosthetic Socket (time frame: After 4 weeks of home use (2 weeks for each socket style)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01546675, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Nov 2014.