Amputation StumpNCT04494555
Do Adaptable Sockets Improve Military Performance?
A study testing Static socket, User adjusted socket and Microprocessor-adjusting sockets in people with Amputation Stump, run by Brooke Army Medical Center at 1 site in United States.
Trial summary
This is a repeated measures prospective study and is no greater than a minimal risk study. All study procedures will be conducted at the Center for the Intrepid (CFI) through collaborative efforts of the Military Performance Lab at the CFI and the Sanders lab at the University of Washington. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Amputation Stump
- What is being tested?
- Static socket, User adjusted socket and Microprocessor-adjusting sockets
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Nov 2020to 10 Jan 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Males and females age 18 - 55 years
- Authorized to receive care at the Center for the Intrepid
- Unilateral or bilateral transtibial amputation
- Have experience performing military relevant tasks (e.g., Active duty Service Member or Veteran)
- Current prosthesis user
- Ability to comply with instructions associated with functional testing
- Able to provide written informed consent
Who cannot join
- Self-reported inability to safely ambulate for a minimum of twenty minutes continuously and unassisted
- History of medical or psychological disease that would preclude safe gait, load carriage, physical, or cognitive functional training or testing within a virtual reality environment as determined by the provider screening the subject (i.e. moderate/severe traumatic brain injury, stroke, renal failure, cardiac or pulmonary problems disease, severe anemia, and other medical conditions)
- Any injury sustained to the upper extremity which would preclude safe physical performance testing
- Self-reported Blindness
- Self-reported Pregnancy
- Self-reported Active infection
Show all 9Show fewer
- Weight above 250 lbs (114 kg)
- Residual limb length shorter than 9cm as this is the minimum distance necessary to attach the bio-impendence sensors
- Score greater than 20% on the Modified Oswestry Low Back Pain Questionnaire as this will indicate greater than minimal disability due to low back pain.
Trial locations and contacts
1 site in 1 country.
United States1 site
Brooke Army Medical Center, Center for the Intrepid
Fort Sam Houston, Texas, 78234
About this study
This is a repeated measures prospective study and is no greater than a minimal risk study. All study procedures will be conducted at the Center for the Intrepid (CFI) through collaborative efforts of the Military Performance Lab at the CFI and the Sanders lab at the University of Washington. Data collected at the CFI will be coded, compiled, and shared with the University of Washington investigators.The objective of the research is to test if microprocessor-adjusting sockets improve Service member performance in Military specific activities compared to (a) user- operated, motor-driven adjustable sockets (i.e. sockets users adjust themselves), and (b) static (traditional) sockets. Investigators also test if microprocessor-adjusting sockets better maintain socket fit and limb fluid volume, and if self-reported outcomes are more favorable than for user-operated or static sockets. The hypotheses to be tested include:
During intense Military specific tasks, compared to the user-adjusted socket and the static socket, the microprocessor-adjusting socket will:
Read more
- minimize translational movement between the residual limb and the prosthetic socket;
- maintain residual limb fluid volume; and
- maximize prosthetic socket comfort.
When using the microprocessor-adjusting socket compared to the user-adjusted socket and the static socket, participants will:
- cover the greatest distance during a simulated combat patrol;
- perform all high intensity Military specific tasks with less pain;
- perform a simulated combat patrol nearer to uninjured levels of performance; and
- rank usability at a level similar to the static socket.
The specific aims are to:
- Fabricate microprocessor-adjusting sockets specific for Service members and Veterans with goals of returning to high-level physical activities
- Evaluate Military task performance in Service members with transtibial amputation using "Readiness Assessments," while wearing three socket configurations: microprocessor-adjusting, user-adjusting, and static
- Simulated combat patrol in a Virtual Realty Environment
- Military version of a Functional Capacity Evaluation
- Characterize user preference and usability of different socket configurations
Read the detailed description
The purpose of the proposed research is to evaluate the use of microprocessor-adjusting sockets during "Readiness Assessments" of Military tasks performed by Service members with transtibial amputation.
Participants will come to the Center For the Intrepid (CFI) for up to 10 visits to complete a pre-monitoring session (assess residual limb health and gather information regarding limb fluid volume); socket fitting session(s) (fitting of three sockets- static socket, a user-adjusted socket, and microprocessor-adjusting socket); and for military readiness assessments for each of the three socket conditions.
Data across the three socket conditions (static socket, user adjusted socket, and Microprocessor-adjusting sockets) will be tested for normality. When it normality can be assumed, a single factor repeated measures ANOVA will test between socket conditions. Mauchly's Test of Sphericity was be used to test if the variance is significantly different across all of the conditions. If the sphericity condition is violated, a Greenhouse-Geisser adjustment will be applied. When a significance effect is detected, pairwise comparisons using a Tukey post-hoc will be performed to determine which conditions are significantly different. When normality cannot be assumed, a Kruskal-Wallis H test will be used. When a significance effect is detected, pairwise comparisons using a Mann-Whitney post-hoc while adjusting the p-value for multiple comparisons will be performed to determine which conditions are significantly different. Statistical significance will be set to p<0.05
- Conditions
- Amputation Stump
- Being tested
- Static socket, User adjusted socket, Microprocessor-adjusting sockets
- Keywords
- amputation, bioimpedance, prosthetic socket, transtibial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Static socketDevice
For the static socket configuration, both the microprocessor control and user control are disabled, and the panels are positioned in their flush configuration to create the user's as-prescribed socket shape.
User adjusted socketDevice
Sockets are configured for user control by disabling automated control and enabling push buttons on the side of the socket to adjust socket size. Each button push effects a socket size change of approximately 0.3% volume. An upper button effects a socket size increase, and a lower button a socket size decrease. The buttons are countersunk so reduce risk of accidental pushes, and they do not function unless the user is stationary. An additional button push will not be executed until motor motion from the prior push has been completed. If a button is continuously held then the motor will continue moving until the button is released. Limits are set on cable length to ensure that sockets sizes threatening to the user's residual limb (too tight) are avoided. The push buttons effect inner-loop control that operates completely within the mechanism, achieving high-resolution adjustment of cable length with minimal error.
Microprocessor-adjusting socketsDevice
A strategy for automatically controlling the size of the socket during walking to compensate for unknown changes in limb volume will be used. The controller is essentially a regulator that continuously measures socket "fit," and adjusts the socket to maintain a prescribed reference set point. Because the fit is automatically sustained, the prosthesis user is unaware of its operation.
| Study group | Role | What they receive |
|---|---|---|
| Adaptable Prosthetic Socket | Experimental | Using measurements of limb-socket displacements from sensors embedded within the socket wall, adaptable sockets make small adjustments to socket size so as to maintain consistent displacements while prosthesis users are active. They do not require the user to stop activity or to touch or modify the prosthesis, and they do not distract users from their objectives. Receives: Device: Static socket; Device: User adjusted socket; Device: Microprocessor-adjusting sockets |
What is being measured
The primary outcome is the main question the study is designed to answer.
Motion of the Residual Limb in the Socket
Angular movement between the residual limb and the prosthetic socket in the sagittal plane.
Measured: Collected during physical performance sessions (Simulated Dismounted Operations (REDoP) and Functional Capacity Evaluation-Military (FCE-M)) Approximately 3 hours.
Motion of Residual Limb in the Socket
Translational movement between the residual limb and the prosthetic socket about the longitudinal axis of the prosthetic socket.
Measured: Collected during physical performance sessions (Simulated Dismounted Operations (REDoP) and Functional Capacity Evaluation-Military (FCE-M)) Approximately 3 hours.
Self-report questionnaires of socket comfort
Change in Socket Comfort Score (SCS) across the Readiness Evaluation during Simulated Dismounted Operations (REDoP) and modified Functional Capacity Evaluation-Military (FCE-M), 0-10 scale.
Measured: SCS recorded before after after each task during REDoP and FCE-M. Approximately 3 hours.
Readiness Evaluation during Simulated Dismounted Operations (REDoP) performance metrics
Total distance traversed during REDoP assessment.
Measured: Assessment administered per condition. Approximately 55 minutes.
Readiness Evaluation during Simulated Dismounted Operations (REDoP) performance metrics
An 11-point (0-10) verbal numerical rating scale (NRS) for pain will be displayed and used to collect the individual's pain level throughout REDoP.
Measured: Recorded after each task during REDoP. Approximately 55 minutes.
Functional Capacity Evaluation-Military (FCE-M) performance metrics
Time to complete each sub-task of the FCE-M.
Measured: Assessment administered per condition. Approximately 30 minutes.
Functional Capacity Evaluation-Military (FCE-M) performance metrics
An 11-point (0-10) verbal numerical rating scale (NRS) for pain will be displayed and used to collect the individual's pain level throughout FCE-M.
Measured: Recorded after each task during REDoP. Approximately 30 minutes.
Total score on the Post-Study System Usability Questionnaire
This is a 19-item instrument for assessing user satisfaction with system usability. The items are 7-point graphic scales, anchored at the ends with the terms "Strongly agree" for 1, "Strongly disagree" for 7, and a "Not applicable" (N/A) point outside the scale.
Measured: After each of the sessions with each socket condition, approximately 3 hours.
Secondary outcomes (5)
Readiness Evaluation during Simulated Dismounted Operations (REDoP) performance metrics
Marksmanship during the simulated ambushes.
Measured: Recorded after each task during REDoP. Approximately 55 minutes.
Readiness Evaluation during Simulated Dismounted Operations (REDoP) performance metrics
Heart rate.
Measured: Recorded during REDoP. Approximately 55 minutes.
Readiness Evaluation during Simulated Dismounted Operations (REDoP) performance metrics
Rating of perceived exertion. A standard 6-20 Borg scale will be used to collect the individual's Rating of Perceived Exertion. Subject's will be asked throughout the session to "rate the difficulty of the task" based on their fatigue level using the Borg scale.
Measured: Recorded after each task during REDoP. 5-10 sec to respond and approximately 55 minutes in total.
Functional Capacity Evaluation-Military (FCE-M) performance metrics
Heart rate.
Measured: Recorded during FCE-M. Approximately 30 minutes.
Functional Capacity Evaluation-Military (FCE-M) performance metrics
Rating of perceived exertion. A standard 6-20 Borg scale will be used to collect the individual's Rating of Perceived Exertion. Subject's will be asked throughout the session to "rate the difficulty of the task" based on their fatigue level using the Borg scale.
Measured: Recorded after each task during FCE-M. 5-10 sec to respond and approximately 30 minutes in total.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2020
- Study start4 Nov 2020
- Primary completion10 Jan 2024
- Study completion10 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (44)Papers the sponsor has linked to this study.
- Other trials for Amputation StumpStudies 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
- Not applicable
- Intervention model
- Single group
- Model description
- This is a repeated measures prospective study.
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brooke Army Medical Center
- Sponsor type
- US federal agency
- Collaborators
- University of Washington
- Responsible party
- Principal investigator, Dr. Walter Lee Childers, Brooke Army Medical Center
- Investigators
- Walter L Childers, PhD, Principal investigator, Extremity Trauma and Amputation Center of Excellence (EACE)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04494555
- Sponsor's protocol ID
- BAMC C.2020.007
- Status last verified
- Feb 2025
- First submitted
- 15 May 2020
- Last updated
- 5 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Sanders JE, Severance MR, Allyn KJ. Computer-socket manufacturing error: how much before it is clinically apparent? J Rehabil Res Dev. 2012;49(4):567-82. doi: 10.1682/jrrd.2011.05.0097.
PubMed 22773260Schnell MD BW. Management of pain in the amputee. . In: JH Bowker JM, ed. Atlas of Limb Prosthetics: Surgical, Prosthetic, and Rehabilitation Principles. 2nd ed. Chicago: Mosby-Year Book; 1982:689-706.
Henrikson KM, Weathersby EJ, Larsen BG, Cagle JC, McLean JB, Sanders JE. An Inductive Sensing System to Measure In-Socket Residual Limb Displacements for People Using Lower-Limb Prostheses. Sensors (Basel). 2018 Nov 9;18(11):3840. doi: 10.3390/s18113840.
PubMed 30423932Sanders JE, Garbini JL, McLean JB, Hinrichs P, Predmore TJ, Brzostowski JT, Redd CB, Cagle JC. A motor-driven adjustable prosthetic socket operated using a mobile phone app: A technical note. Med Eng Phys. 2019 Jun;68:94-100. doi: 10.1016/j.medengphy.2019.04.003. Epub 2019 Apr 23.
PubMed 31028009Sanders JE, Zachariah SG, Jacobsen AK, Fergason JR. Changes in interface pressures and shear stresses over time on trans-tibial amputee subjects ambulating with prosthetic limbs: comparison of diurnal and six-month differences. J Biomech. 2005 Aug;38(8):1566-73. doi: 10.1016/j.jbiomech.2004.08.008.
PubMed 15958212Larsen BG, McLean JB, Redd CB, Brzostowski JT, Allyn KJ, Sanders JE. How do socket size adjustments during ambulation affect residual limb fluid volume? Case study results. JPO: Journal of Prosthetics and Orthotics. 2019;31(1):58-66.
McLean JB, Redd CB, Larsen BG, Garbini JL, Brzostowski JT, Hafner BJ, Sanders JE. Socket size adjustments in people with transtibial amputation: Effects on residual limb fluid volume and limb-socket distance. Clin Biomech (Bristol). 2019 Mar;63:161-171. doi: 10.1016/j.clinbiomech.2019.02.022. Epub 2019 Mar 2.
PubMed 30901641Brzostowski JT, Larsen BG, Youngblood RT, Ciol MA, Hafner BJ, Gurrey CJ, McLean JB, Allyn KJ, Sanders JE. Adjustable sockets may improve residual limb fluid volume retention in transtibial prosthesis users. Prosthet Orthot Int. 2019 Jun;43(3):250-256. doi: 10.1177/0309364618820140. Epub 2019 Jan 10.
PubMed 30628522Fernie GR, Holliday PJ. Volume fluctuations in the residual limbs of lower limb amputees. Arch Phys Med Rehabil. 1982 Apr;63(4):162-5.
PubMed 7082139Larsen BG, Allyn KJ, Ciol MA, Sanders JE. Performance of a sensor to monitor socket fit: Comparison with practitioner clinical assessment. JPO: Journal of Prosthetics and Orthotics. 2019.
Larsen BG, McLean JB, Allyn KJ, Brzostowski JT, Garbini JL, Sanders JE. How do transtibial residual limbs adjust to intermittent incremental socket volume changes? Prosthet Orthot Int. 2019 Oct;43(5):528-539. doi: 10.1177/0309364619864771. Epub 2019 Jul 24.
PubMed 31339448Collinger J, Grindle G, Heiner C, et al. Roadmap for future amputee care research. Care of the Combat Amputee. Washington, DC: Borden Institute, Walter Reed Army Medical Center; 2009.
Berke GM, Fergason J, Milani JR, Hattingh J, McDowell M, Nguyen V, Reiber GE. Comparison of satisfaction with current prosthetic care in veterans and servicemembers from Vietnam and OIF/OEF conflicts with major traumatic limb loss. J Rehabil Res Dev. 2010;47(4):361-71. doi: 10.1682/jrrd.2009.12.0193.
PubMed 20803404Reiber GE, McFarland LV, Hubbard S, Maynard C, Blough DK, Gambel JM, Smith DG. Servicemembers and veterans with major traumatic limb loss from Vietnam war and OIF/OEF conflicts: survey methods, participants, and summary findings. J Rehabil Res Dev. 2010;47(4):275-97. doi: 10.1682/jrrd.2010.01.0009.
PubMed 20803399Force BIT. Dismounted Complex Blast Injury. Paper presented at: Report of the Army Dismounted Complex Blast Injury Task Force2011.
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Do Adaptable Sockets Improve Military Performance?
- ClinicalTrials.gov ID
- NCT04494555
- Acronym / sponsor ID
- BAMC C.2020.007
- Conditions
- Amputation Stump
- Keywords
- amputation, bioimpedance, prosthetic socket, transtibial
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Brooke Army Medical CenterUS federal agency
- Collaborators
- University of Washington
- Study start
- 4 Nov 2020 (actual)
- Primary completion
- 10 Jan 2024 (actual)
- Study completion
- 10 Jan 2024 (actual)
- First posted
- 31 Jul 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a repeated measures prospective study and is no greater than a minimal risk study. All study procedures will be conducted at the Center for the Intrepid (CFI) through collaborative efforts of the Military Performance Lab at the CFI and the Sanders lab at the University of Washington. Data collected at the CFI will be coded, compiled, and shared with the University of Washington investigators.The objective of the research is to test if microprocessor-adjusting sockets improve Service member performance in Military specific activities compared to (a) user- operated, motor-driven adjustable sockets (i.e. sockets users adjust themselves), and (b) static (traditional) sockets. Investigators also test if microprocessor-adjusting sockets better maintain socket fit and limb fluid volume, and if self-reported outcomes are more favorable than for user-operated or static sockets. The hypotheses to be tested include:
During intense Military specific tasks, compared to the user-adjusted socket and the static socket, the microprocessor-adjusting socket will:
- minimize translational movement between the residual limb and the prosthetic socket;
- maintain residual limb fluid volume; and
- maximize prosthetic socket comfort.
When using the microprocessor-adjusting socket compared to the user-adjusted socket and the static socket, participants will:
- cover the greatest distance during a simulated combat patrol;
- perform all high intensity Military specific tasks with less pain;
- perform a simulated combat patrol nearer to uninjured levels of performance; and
- rank usability at a level similar to the static socket.
The specific aims are to:
- Fabricate microprocessor-adjusting sockets specific for Service members and Veterans with goals of returning to high-level physical activities
- Evaluate Military task performance in Service members with transtibial amputation using "Readiness Assessments," while wearing three socket configurations: microprocessor-adjusting, user-adjusting, and static
- Simulated combat patrol in a Virtual Realty Environment
- Military version of a Functional Capacity Evaluation
- Characterize user preference and usability of different socket configurations
Detailed description
The purpose of the proposed research is to evaluate the use of microprocessor-adjusting sockets during "Readiness Assessments" of Military tasks performed by Service members with transtibial amputation.
Participants will come to the Center For the Intrepid (CFI) for up to 10 visits to complete a pre-monitoring session (assess residual limb health and gather information regarding limb fluid volume); socket fitting session(s) (fitting of three sockets- static socket, a user-adjusted socket, and microprocessor-adjusting socket); and for military readiness assessments for each of the three socket conditions.
Data across the three socket conditions (static socket, user adjusted socket, and Microprocessor-adjusting sockets) will be tested for normality. When it normality can be assumed, a single factor repeated measures ANOVA will test between socket conditions. Mauchly's Test of Sphericity was be used to test if the variance is significantly different across all of the conditions. If the sphericity condition is violated, a Greenhouse-Geisser adjustment will be applied. When a significance effect is detected, pairwise comparisons using a Tukey post-hoc will be performed to determine which conditions are significantly different. When normality cannot be assumed, a Kruskal-Wallis H test will be used. When a significance effect is detected, pairwise comparisons using a Mann-Whitney post-hoc while adjusting the p-value for multiple comparisons will be performed to determine which conditions are significantly different. Statistical significance will be set to p<0.05
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This is a repeated measures prospective study.
| Arm | Type | Receives |
|---|---|---|
| Adaptable Prosthetic Socket | Experimental | Device: Static socket, Device: User adjusted socket, Device: Microprocessor-adjusting socketsUsing measurements of limb-socket displacements from sensors embedded within the socket wall, adaptable sockets make small adjustments to socket size so as to maintain consistent displacements while prosthesis users are active. They do not require the user to stop activity or to touch or modify the prosthesis, and they do not distract users from their objectives. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Males and females age 18 - 55 years
- Authorized to receive care at the Center for the Intrepid
- Unilateral or bilateral transtibial amputation
- Have experience performing military relevant tasks (e.g., Active duty Service Member or Veteran)
- Current prosthesis user
Key exclusion criteria (9 listed)
- Self-reported inability to safely ambulate for a minimum of twenty minutes continuously and unassisted
- History of medical or psychological disease that would preclude safe gait, load carriage, physical, or cognitive functional training or testing within a virtual reality environment as determined by the provider screening the subject (i.e. moderate/severe traumatic brain injury, stroke, renal failure, cardiac or pulmonary problems disease, severe anemia, and other medical conditions)
- Any injury sustained to the upper extremity which would preclude safe physical performance testing
- Self-reported Blindness
- Self-reported Pregnancy
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 |
|---|---|---|
| Static socketFor the static socket configuration, both the microprocessor control and user control are disabled, and the panels are positioned in their flush configuration to create the user's as-prescribed socket shape. | Device | Adaptable Prosthetic Socket |
| User adjusted socketSockets are configured for user control by disabling automated control and enabling push buttons on the side of the socket to adjust socket size. Each button push effects a socket size change of approximately 0.3% volume. An upper button effects a socket size increase, and a lower button a socket size decrease. The buttons are countersunk so reduce risk of accidental pushes, and they do not function unless the user is stationary. An additional button push will not be executed until motor motion from the prior push has been completed. If a button is continuously held then the motor will continue moving until the button is released. Limits are set on cable length to ensure that sockets sizes threatening to the user's residual limb (too tight) are avoided. The push buttons effect inner-loop control that operates completely within the mechanism, achieving high-resolution adjustment of cable length with minimal error. | Device | Adaptable Prosthetic Socket |
| Microprocessor-adjusting socketsA strategy for automatically controlling the size of the socket during walking to compensate for unknown changes in limb volume will be used. The controller is essentially a regulator that continuously measures socket "fit," and adjusts the socket to maintain a prescribed reference set point. Because the fit is automatically sustained, the prosthesis user is unaware of its operation. | Device | Adaptable Prosthetic Socket |
Primary outcome
Motion of the Residual Limb in the Socket
Time frame: Collected during physical performance sessions (Simulated Dismounted Operations (REDoP) and Functional Capacity Evaluation-Military (FCE-M)) Approximately 3 hours.
Angular movement between the residual limb and the prosthetic socket in the sagittal plane.
Motion of Residual Limb in the Socket
Time frame: Collected during physical performance sessions (Simulated Dismounted Operations (REDoP) and Functional Capacity Evaluation-Military (FCE-M)) Approximately 3 hours.
Translational movement between the residual limb and the prosthetic socket about the longitudinal axis of the prosthetic socket.
Self-report questionnaires of socket comfort
Time frame: SCS recorded before after after each task during REDoP and FCE-M. Approximately 3 hours.
Change in Socket Comfort Score (SCS) across the Readiness Evaluation during Simulated Dismounted Operations (REDoP) and modified Functional Capacity Evaluation-Military (FCE-M), 0-10 scale.
Readiness Evaluation during Simulated Dismounted Operations (REDoP) performance metrics
Time frame: Assessment administered per condition. Approximately 55 minutes.
Total distance traversed during REDoP assessment.
Readiness Evaluation during Simulated Dismounted Operations (REDoP) performance metrics
Time frame: Recorded after each task during REDoP. Approximately 55 minutes.
An 11-point (0-10) verbal numerical rating scale (NRS) for pain will be displayed and used to collect the individual's pain level throughout REDoP.
Functional Capacity Evaluation-Military (FCE-M) performance metrics
Time frame: Assessment administered per condition. Approximately 30 minutes.
Time to complete each sub-task of the FCE-M.
Functional Capacity Evaluation-Military (FCE-M) performance metrics
Time frame: Recorded after each task during REDoP. Approximately 30 minutes.
An 11-point (0-10) verbal numerical rating scale (NRS) for pain will be displayed and used to collect the individual's pain level throughout FCE-M.
Total score on the Post-Study System Usability Questionnaire
Time frame: After each of the sessions with each socket condition, approximately 3 hours.
This is a 19-item instrument for assessing user satisfaction with system usability. The items are 7-point graphic scales, anchored at the ends with the terms "Strongly agree" for 1, "Strongly disagree" for 7, and a "Not applicable" (N/A) point outside the scale.
5 secondary outcomes
Readiness Evaluation during Simulated Dismounted Operations (REDoP) performance metrics
Time frame: Recorded after each task during REDoP. Approximately 55 minutes.
Readiness Evaluation during Simulated Dismounted Operations (REDoP) performance metrics
Time frame: Recorded during REDoP. Approximately 55 minutes.
Readiness Evaluation during Simulated Dismounted Operations (REDoP) performance metrics
Time frame: Recorded after each task during REDoP. 5-10 sec to respond and approximately 55 minutes in total.
Functional Capacity Evaluation-Military (FCE-M) performance metrics
Time frame: Recorded during FCE-M. Approximately 30 minutes.
Functional Capacity Evaluation-Military (FCE-M) performance metrics
Time frame: Recorded after each task during FCE-M. 5-10 sec to respond and approximately 30 minutes in total.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2025.
- Background: PubMed 22773260Sanders JE, Severance MR, Allyn KJ. Computer-socket manufacturing error: how much before it is clinically apparent? J Rehabil Res Dev. 2012;49(4):567-82. doi: 10.1682/jrrd.2011.05.0097.
- BackgroundSchnell MD BW. Management of pain in the amputee. . In: JH Bowker JM, ed. Atlas of Limb Prosthetics: Surgical, Prosthetic, and Rehabilitation Principles. 2nd ed. Chicago: Mosby-Year Book; 1982:689-706.
- Background: PubMed 30423932Henrikson KM, Weathersby EJ, Larsen BG, Cagle JC, McLean JB, Sanders JE. An Inductive Sensing System to Measure In-Socket Residual Limb Displacements for People Using Lower-Limb Prostheses. Sensors (Basel). 2018 Nov 9;18(11):3840. doi: 10.3390/s18113840.
- Background: PubMed 31028009Sanders JE, Garbini JL, McLean JB, Hinrichs P, Predmore TJ, Brzostowski JT, Redd CB, Cagle JC. A motor-driven adjustable prosthetic socket operated using a mobile phone app: A technical note. Med Eng Phys. 2019 Jun;68:94-100. doi: 10.1016/j.medengphy.2019.04.003. Epub 2019 Apr 23.
- Background: PubMed 15958212Sanders JE, Zachariah SG, Jacobsen AK, Fergason JR. Changes in interface pressures and shear stresses over time on trans-tibial amputee subjects ambulating with prosthetic limbs: comparison of diurnal and six-month differences. J Biomech. 2005 Aug;38(8):1566-73. doi: 10.1016/j.jbiomech.2004.08.008.
- BackgroundLarsen BG, McLean JB, Redd CB, Brzostowski JT, Allyn KJ, Sanders JE. How do socket size adjustments during ambulation affect residual limb fluid volume? Case study results. JPO: Journal of Prosthetics and Orthotics. 2019;31(1):58-66.
- Background: PubMed 30901641McLean JB, Redd CB, Larsen BG, Garbini JL, Brzostowski JT, Hafner BJ, Sanders JE. Socket size adjustments in people with transtibial amputation: Effects on residual limb fluid volume and limb-socket distance. Clin Biomech (Bristol). 2019 Mar;63:161-171. doi: 10.1016/j.clinbiomech.2019.02.022. Epub 2019 Mar 2.
- Background: PubMed 30628522Brzostowski JT, Larsen BG, Youngblood RT, Ciol MA, Hafner BJ, Gurrey CJ, McLean JB, Allyn KJ, Sanders JE. Adjustable sockets may improve residual limb fluid volume retention in transtibial prosthesis users. Prosthet Orthot Int. 2019 Jun;43(3):250-256. doi: 10.1177/0309364618820140. Epub 2019 Jan 10.
- Background: PubMed 7082139Fernie GR, Holliday PJ. Volume fluctuations in the residual limbs of lower limb amputees. Arch Phys Med Rehabil. 1982 Apr;63(4):162-5.
- BackgroundLarsen BG, Allyn KJ, Ciol MA, Sanders JE. Performance of a sensor to monitor socket fit: Comparison with practitioner clinical assessment. JPO: Journal of Prosthetics and Orthotics. 2019.
- Background: PubMed 31339448Larsen BG, McLean JB, Allyn KJ, Brzostowski JT, Garbini JL, Sanders JE. How do transtibial residual limbs adjust to intermittent incremental socket volume changes? Prosthet Orthot Int. 2019 Oct;43(5):528-539. doi: 10.1177/0309364619864771. Epub 2019 Jul 24.
- BackgroundCollinger J, Grindle G, Heiner C, et al. Roadmap for future amputee care research. Care of the Combat Amputee. Washington, DC: Borden Institute, Walter Reed Army Medical Center; 2009.
- Individual participant dataSharing planned: No
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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.
Walter L Childers, PhD principal investigator
Extremity Trauma and Amputation Center of Excellence (EACE)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Static socket, User adjusted socket and Microprocessor-adjusting sockets in people with Amputation Stump, run by Brooke Army Medical Center at 1 site 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 7 inclusion and 9 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 5 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Motion of the Residual Limb in the Socket (time frame: Collected during physical performance sessions (Simulated Dismounted Operations (REDoP) and Functional Capacity Evaluation-Military (FCE-M)) Approximately 3 hours.). The study lists 8 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 NCT04494555, which also lists 44 linked publications.
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 5 Feb 2025.