Complications of the Amputated LimbNCT03199222
Prosthetic Smart Socket Technology to Improve Patient Interaction, Usability, Comfort, Fit, and Function.
A study testing Prosthetic smart socket technology with patient prompting in people with Complications of the Amputated Limb, run by University of South Florida at 1 site in United States.
Trial summary
A common problem for the intermediate preparatory stage of prosthetic rehabilitation is distal pressure, due to commonly compromised sensation and lack of understanding how to address it in a newly fitted prosthesis. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Complications of the Amputated Limb
- What is being tested?
- Prosthetic smart socket technology with patient prompting
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 29 Mar 2018to Jul 2019
- 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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Unilateral transtibial amputation
- Unilateral revision or reconstruction of transtibial amputation
- Candidate for intermediate stage (i.e. preparatory) socket fitting
- Male or female, of any ethnicity
- 18-60 yrs of age (i.e. active military age)
- 100-275 lbs.
Who cannot join
- Body weight <100 or >275 lbs
- Does not speak English or Spanish
- Any other level of amputation than unilateral TTA
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
University of South Florida
Tampa, Florida, 33612
M. Jason Highsmith, DPT, CP, 813-974-3806, mhighsmi@health.usf.edu
About this study
A common problem for the intermediate preparatory stage of prosthetic rehabilitation is distal pressure, due to commonly compromised sensation and lack of understanding how to address it in a newly fitted prosthesis. Excessive pressure can lead to severe skin breakdown, infection, surgical revision, re-hospitalization and delayed rehab. To prevent this common problem among rehabilitating amputees, smart socket technology has been developed to better identify problems that may occur. The Smart Socket Technology including Prompting (SST+P) in this pre-clinical project proposal provides a step activity monitor and senses distal pressure, which is novel to the technology. When excessive pressure is sensed on the residual limb, it will send a signal to the user's smart phone to make an adjustment. This prompting improves patient interaction and may prevent problems as a result of common volume fluctuation and compromised sensation. The purpose of this clinical trial is to determine if the ALPS iForce smart socket technology with prompting (SST+P) will improve patient interaction, usability, comfort, fit, function and health economy outcomes compared with the standard of care (SOC) clinical practice protocols of fitting prosthetic socket interfaces
Read the detailed description
Limb loss requires prosthetic use. Prostheses usually consist of 2 components: 1) a soft interface to protect the skin and underlying musculoskeletal tissue and 2) a structural interface to enable attachment of prosthetic components to the human body. The interface connects the patient's body to the prosthetic components and thus ground during gait. The interface has 2 purposes: 1) to distribute weight-bearing forces throughout the entire residual limb (RL) and 2) to suspend the prosthesis during swing phase and unweighting. The interface assists in distributing vertical loads during weight bearing to minimize focal loading on pressure intolerant tissues. The interface also suspends prosthetic components to the RL in swing phase and other periods of unweighting.
Many amputees experience RL complications and decreased mobility resulting from the inability to detect excess pressure or a lack of distal contact with newly fit and poorly fit interfaces. A smart socket technology interface could benefit every new prosthetic patient by prompting the user of a compromised socket fit prior to inhibiting functional use and safety. Further, the smart socket technology interface may ultimately prevent other health complications and improve patient interaction, usability, comfort, fit and function. The ALPS iForce most economically measures these variables more comprehensively than any other known single device. Therefore the smart socket interface technology chosen for this proposal is the ALPs iForce. The iForce tracks pressure over time and indicates to the user when positive or negative distal pressure exists by providing volume management suggestions (i.e. sock-ply adjustments). The user interacts with data measured sent wirelessly to an application on a smart phone (Android/iOS/Windows), handheld device, or PC. Suggestions may include removal or application of prosthetic socks over the RL, or other appropriate volume management strategies, to improve fit and comfort. Early warning to possible skin irritation and breakdown may lead to a healthier limb.
- Conditions
- Complications of the Amputated Limb
- Being tested
- Prosthetic smart socket technology with patient prompting
- Keywords
- amputation, transtibial, socket, pressure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prosthetic smart socket technology with patient promptingDevice
The smart socket technology will send feedback to the user's smartphone with suggestions including the removal or application of prosthetic socks over the residual limb or other volume management strategies to improve fit and comfort.
| Study group | Role | What they receive |
|---|---|---|
| Arm 1: Smart socket technology w/patient prompting | Experimental | The prosthetic user WILL receive prompting by the smart socket technology regarding improper fit and suggestions for how to a restore a proper fit (i.e socks). Investigators will have access to the Smart Socket Technology database. Receives: Device: Prosthetic smart socket technology with patient prompting |
| Arm 2: Clinical protocol. No patient prompting | No intervention | The prosthetic user WILL NOT receive prompting by the smart socket technology regarding improper fit and suggestions for how to a restore a proper fit (i.e socks). However, investigators will have access to the Smart Socket Technology database. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intermediate stage prosthetic complications
Clinical documentation will track incidence of dermatologic issues, skin breakdown, sock ply, circumference, infection and wound severity.
Measured: Will be tracked for 120 days.
Limb volume activity of the residual limb
Limb volume will be tracked through clinical documentation including residual limb volumetrics (circumferential measurements), sock-ply changes (journal), and required interface changes will be used to record volume activity and corresponding consequence and management strategies.
Measured: Will be tracked for 120 days
Intermediate stage prosthetic complications (clinical documentation)
Re-hospitalization rate
Measured: Will be tracked for 120 days
Intermediate stage prosthetic complications (clinical documentation)
Revision rate will be documented
Measured: Will be tracked for 120 days
Secondary outcomes (4)
Balance and Stability
Post-amputation balance and stability will be tested with the Amputee Mobility Predictor (AMP). The AMP is a brief physical assessment (≈15min to administer) to objectively determine a lower extremity amputee's functional level. Subjects are assessed by progressing through a hierarchy of mobility tasks including sitting balance, standing balance, obstacle crossing, variable gait speed and stair gait.
Measured: 30 days post-amputation and at end of trial (120 days)
Mobility
L-Test of Functional Mobility and the 2 minute walk test will be used to assess mobility. The L-Test is practical in design and intended to be used in a standard clinical hallway.29 Subjects begins the test seated in a chair.
The patient rises from the chair, walks three meters, turns 90 degrees and then walks an additional seven meters. Upon completing seven meters, the subject turns 180 degrees, returns, turns 90 degrees to face the chair, and returns the three meters to his chair, where they retake the seat.
Measured: 30 days post-amputation and at end of trial (120 days)
Step Activity
The Smart Socket Technology in this proposal has the capability of measuring step count activity. Step activity monitoring is utilized to count the number of steps taken.
Measured: 120 days
Step Activity
Step activity monitoring is used to count the duration of step bout activity per stepping episode.
Measured: 120 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2017
- Study start29 Mar 2018
- Primary completionMay 2019 (estimated)
- Study completionJul 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Complications of the Amputated LimbStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of South Florida
- Sponsor type
- University, hospital or other
- Collaborators
- U.S. Army Medical Research Acquisition Activity
- Responsible party
- Sponsor
- Investigators
- Jason Highsmith, PhD, Principal investigator, University of South Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03199222
- Sponsor's protocol ID
- Pro00026455
- Status last verified
- Mar 2019
- First submitted
- 4 Apr 2017
- Last updated
- 20 Mar 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prosthetic Smart Socket Technology to Improve Patient Interaction, Usability, Comfort, Fit, and Function.
- ClinicalTrials.gov ID
- NCT03199222
- Acronym / sponsor ID
- Pro00026455
- Conditions
- Complications of the Amputated Limb
- Keywords
- amputation, transtibial, socket, pressure
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University of South FloridaUniversity, hospital or other
- Collaborators
- U.S. Army Medical Research Acquisition Activity
- Study start
- 29 Mar 2018 (actual)
- Primary completion
- May 2019 (estimated)
- Study completion
- Jul 2019 (estimated)
- First posted
- 26 Jun 2017 (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.
A common problem for the intermediate preparatory stage of prosthetic rehabilitation is distal pressure, due to commonly compromised sensation and lack of understanding how to address it in a newly fitted prosthesis. Excessive pressure can lead to severe skin breakdown, infection, surgical revision, re-hospitalization and delayed rehab. To prevent this common problem among rehabilitating amputees, smart socket technology has been developed to better identify problems that may occur. The Smart Socket Technology including Prompting (SST+P) in this pre-clinical project proposal provides a step activity monitor and senses distal pressure, which is novel to the technology. When excessive pressure is sensed on the residual limb, it will send a signal to the user's smart phone to make an adjustment. This prompting improves patient interaction and may prevent problems as a result of common volume fluctuation and compromised sensation. The purpose of this clinical trial is to determine if the ALPS iForce smart socket technology with prompting (SST+P) will improve patient interaction, usability, comfort, fit, function and health economy outcomes compared with the standard of care (SOC) clinical practice protocols of fitting prosthetic socket interfaces
Detailed description
Limb loss requires prosthetic use. Prostheses usually consist of 2 components: 1) a soft interface to protect the skin and underlying musculoskeletal tissue and 2) a structural interface to enable attachment of prosthetic components to the human body. The interface connects the patient's body to the prosthetic components and thus ground during gait. The interface has 2 purposes: 1) to distribute weight-bearing forces throughout the entire residual limb (RL) and 2) to suspend the prosthesis during swing phase and unweighting. The interface assists in distributing vertical loads during weight bearing to minimize focal loading on pressure intolerant tissues. The interface also suspends prosthetic components to the RL in swing phase and other periods of unweighting.
Many amputees experience RL complications and decreased mobility resulting from the inability to detect excess pressure or a lack of distal contact with newly fit and poorly fit interfaces. A smart socket technology interface could benefit every new prosthetic patient by prompting the user of a compromised socket fit prior to inhibiting functional use and safety. Further, the smart socket technology interface may ultimately prevent other health complications and improve patient interaction, usability, comfort, fit and function. The ALPS iForce most economically measures these variables more comprehensively than any other known single device. Therefore the smart socket interface technology chosen for this proposal is the ALPs iForce. The iForce tracks pressure over time and indicates to the user when positive or negative distal pressure exists by providing volume management suggestions (i.e. sock-ply adjustments). The user interacts with data measured sent wirelessly to an application on a smart phone (Android/iOS/Windows), handheld device, or PC. Suggestions may include removal or application of prosthetic socks over the RL, or other appropriate volume management strategies, to improve fit and comfort. Early warning to possible skin irritation and breakdown may lead to a healthier limb.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm 1: Smart socket technology w/patient prompting | Experimental | Device: Prosthetic smart socket technology with patient promptingThe prosthetic user WILL receive prompting by the smart socket technology regarding improper fit and suggestions for how to a restore a proper fit (i.e socks). Investigators will have access to the Smart Socket Technology database. |
| Arm 2: Clinical protocol. No patient prompting | No intervention | –The prosthetic user WILL NOT receive prompting by the smart socket technology regarding improper fit and suggestions for how to a restore a proper fit (i.e socks). However, investigators will have access to the Smart Socket Technology database. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Unilateral transtibial amputation
- Unilateral revision or reconstruction of transtibial amputation
- Candidate for intermediate stage (i.e. preparatory) socket fitting
- Male or female, of any ethnicity
- 18-60 yrs of age (i.e. active military age)
Key exclusion criteria (3 listed)
- Body weight <100 or >275 lbs
- Does not speak English or Spanish
- Any other level of amputation than unilateral TTA
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 |
|---|---|---|
| Prosthetic smart socket technology with patient promptingThe smart socket technology will send feedback to the user's smartphone with suggestions including the removal or application of prosthetic socks over the residual limb or other volume management strategies to improve fit and comfort. | Device | Arm 1: Smart socket technology w/patient prompting |
Primary outcome
Intermediate stage prosthetic complications
Time frame: Will be tracked for 120 days.
Clinical documentation will track incidence of dermatologic issues, skin breakdown, sock ply, circumference, infection and wound severity.
Limb volume activity of the residual limb
Time frame: Will be tracked for 120 days
Limb volume will be tracked through clinical documentation including residual limb volumetrics (circumferential measurements), sock-ply changes (journal), and required interface changes will be used to record volume activity and corresponding consequence and management strategies.
Intermediate stage prosthetic complications (clinical documentation)
Time frame: Will be tracked for 120 days
Re-hospitalization rate
Intermediate stage prosthetic complications (clinical documentation)
Time frame: Will be tracked for 120 days
Revision rate will be documented
4 secondary outcomes
Balance and Stability
Time frame: 30 days post-amputation and at end of trial (120 days)
Mobility
Time frame: 30 days post-amputation and at end of trial (120 days)
Step Activity
Time frame: 120 days
Step Activity
Time frame: 120 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2019.
- Individual participant dataSharing planned: No
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.
Jason Highsmith, PhD principal investigator
University of South Florida
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Prosthetic smart socket technology with patient prompting in people with Complications of the Amputated Limb, run by University of South Florida 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 6 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 20 Mar 2019. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jason Highsmith, PhD (813-625-5406, michael.highsmith@va.gov), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intermediate stage prosthetic complications (time frame: Will be tracked for 120 days.). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 20 Mar 2019.