AmputationRESCUNCT04043234
RESCU System for Robust Upper Limb Prosthesis Control
A study testing RESCU and Pattern Recognition in people with Amputation and Upper Limb, run by Infinite Biomedical Technologies at 1 site in United States.
Trial summary
This study will compare the use of RESCU [Experimental] Prosthesis with a [Standard] pattern recognition prosthesis in a clinical setting and in unsupervised daily activity. The protocol will follow a single case experimental design (SCED) to compensate for the limited size of the patient population. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Amputation, Upper Limb
- What is being tested?
- RESCU and Pattern Recognition
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Nov 2023to 19 Dec 2023
- 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
- Trans-radial limb difference.
- Candidate for a 2+ degree-of-freedom (DoF) myoelectric pattern recognition prosthesis as determined by the study prosthetist
- Active pattern recognition myoelectric prosthesis user
- Fluent in English
- Age of 18 years or greater
Who cannot join
- Patients with a residual limb that is unhealed from the amputation surgery
- Patients with easily damaged or sensitive skin who would not tolerate EMG electrodes
- Unhealed wounds
- Significant cognitive deficits as determined upon clinical evaluation
- Significant neurological deficits as determined upon clinical evaluation
- Significant physical deficits of the residual limb impacting full participation in the study as determined upon clinical evaluation
- Uncontrolled pain or phantom pain impacting full participation in the study as determined upon clinical evaluation
- Serious uncontrolled medical problems as judged by the project therapist
Trial locations and contacts
1 site in 1 country.
About this study
Official title: User-driven Retrospectively Supervised Classification Updating (RESCU) System for Robust Upper Limb Prosthesis Control
This study will compare the use of RESCU [Experimental] Prosthesis with a [Standard] pattern recognition prosthesis in a clinical setting and in unsupervised daily activity. The protocol will follow a single case experimental design (SCED) to compensate for the limited size of the patient population. Each of the participants will use the Standard and Experimental and systems over a 35-day period. The Standard system will include at least two controllable DoFs (hand, wrist, multi-articulated hand, etc) and a commercially-available pattern recognition controller. The RESCU system will use the same components as the Standard system but will differ with respect to incorporating eight IBT Element Electrodes (as required for pattern recognition control) and the RESCU control software. The hypothesis is that pattern recognition will outperform the commercially-available control strategy for most participants on in-clinic, at-home usage, and subjective measures.
Read the detailed description
The AB sequence for the study protocol is described below, where control type A is the Standard prosthesis and control type B is the Experimental prosthesis.
On Day 0, the participant will be evaluated with the Standard prosthesis. A series of Measures (as defined in the next paragraph) will then be recorded. The participant will then take the prosthesis home for one week, and daily use data will be recorded. The participant will return to the clinic for Day 7 Measures and download of the daily use data. During this session, the participant will be fit with the second system, undergo occupational therapy in the clinic, and Measures will be recorded. There will be no washout period as the prosthesis is expected to be in daily use. The participants will go home for a four-week period and return on Day 35 for a third set of Measures. At this time, the participant will be asked which prosthesis he/she prefers.
There are limited functional outcome assessment options for the planned comparison. However, the investigators will test functional measures at the clinic appointments, examine daily use data, and administer several qualitative surveys to assess participant outcomes.
- Conditions
- Amputation, Upper Limb
- Being tested
- RESCU, Pattern Recognition
- Keywords
- upper limb, amputation, prosthesis, myoelectric, pattern recognition
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RESCUDevice
Retrospectively Supervised Classification Updating (RESCU) is founded on two innovations that promise significant improvement in performance and outcome. The first is a highly robust machine intelligence algorithm, an Extreme Learning Machine with Adaptive Sparse Representation (EASRC), and the second is a novel adaptive learning algorithm and communication interface we call Nessa. We contend that these two technologies allow the prosthetic device to adapt to its user from the initial fitting through continuing, long-term use in the activities of daily living, shifting the paradigm of training from the current prospective data gathering methods to a more dynamic retrospective application.
Pattern RecognitionDevice
Pattern recognition prostheses associate the patterns of activity of multiple EMG sites to the action of a prosthesis. Such strategies have historically required prospective calibration of the EMG activation patterns.
| Study group | Role | What they receive |
|---|---|---|
| Single-Case Experimental Design | Experimental | Participants act as their own controls. They first use the Control device, which includes the pattern recognition controller, 8 electrodes, batteries, socket, frame, and prosthesis terminal device (hand/wrist/elbow). Participants are then transitioned to the Experimental device, which includes the RESCU controller, Apple iPad, 8 electrodes, batteries, socket, frame, and prosthesis terminal device (hand/wrist/elbow). Receives: Device: RESCU; Device: Pattern Recognition |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Daily Prosthesis Use Duration
Prosthesis usage time was monitored as a proxy for user satisfaction, under the assumption that when an individual is more satisfied with their prosthetic solution, they will use it more in their daily lives. For the experimental intervention, the mean daily prosthesis use duration is reported as the average number of hours the prosthesis was used daily over the evaluation period (i.e., four weeks). For the control intervention, the mean daily prosthesis use duration is reported as the average number of hours the prosthesis was used daily before the evaluation period (i.e., at baseline).
Measured: Baseline, 4 weeks
Secondary outcomes (7)
Activities Measure for Upper Limb Amputees (AM-ULA)
The AM-ULA is a clinician-graded measure of activity performance for adults with upper limb amputation that considers task completion, speed, movement quality, skillfulness of prosthetic use, and independence to quantify how functional an individual is while using their prosthesis. A higher score indicates overall greater prosthesis functionality.
Measured: Baseline, Post-Fitting, Post-Intervention
Orthotics and Prosthetics User's Survey Upper Extremity Functional Status (OPUS UEFS)
The OPUS UEFS is a self-report questionnaire that asks respondents to score how easily they can complete several activities of daily living (e.g., drink from a paper cup, brush hair, etc.). A higher score indicates greater function.
Measured: Baseline, Post-Intervention
Trinity Amputation and Prosthesis Experience Survey for Upper Limb Amputation (TAPES-ULA)
The Psychosocial Adjustment to Amputation measure (originally modified from the TAPES-ULA) is a self-report questionnaire that asks respondents to measure how well they have adapted to life with their amputation and prosthesis. This measure was administered specifically to quantify prosthesis use and return to work. The measure contains two subscales: a 7-item Adjustment to Limitation subscale and a 9-item Work and Independence subscale. For the Adjustment to Limitation subscale, a higher score indicates greater adjustment. For the Work and Independence subscale, a higher score indicates greater feelings of dependency.
Measured: Baseline, Post-Intervention
PROMIS Satisfaction Short Form 8a
The PROMIS Satisfaction Short Form 8a is a self-report questionnaire designed to query individuals on their satisfaction with their ability to participate in social roles and activities. This measure was chosen due to its ability to capture patient satisfaction with their ability to participate in activities of daily living throughout various roles in life. A higher score indicates higher satisfaction with their ability to participate in work and home life.
Measured: Baseline, Post-Intervention
Pain Scale
Participants were queried about their experience of pain, both in their residual limb and in their phantom limb perception to detect if the choice of control strategy affects pain levels. From 0 to 10, a higher score indicates more feelings of pain.
Measured: Baseline, Post-Fitting, Post-Intervention
Socket Comfort Score
Socket comfort score was collected to determine if outside factors (i.e., socket fit) are affecting function during the take-home period.
Measured: Baseline, Post-Fitting, Post-Intervention
Range of Motion (of Residual Joints)
The range of motion of the residual joints is an important factor when judging how well a prosthesis fits a participant, with a higher joint range of motion indicating a better fitting socket. For the individuals in this study (i.e., those with below-elbow amputations), the elbow range-of-motion is expected to be most affected by a prosthesis socket with a poor fit.
Measured: Baseline, Post-Fitting
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2019
- Study start7 Nov 2023
- Primary completion19 Dec 2023
- Study completion19 Dec 2023
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.
- Other trials for AmputationStudies 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
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Single-Case Experimental Design (SCED)
- Masking
- None (open label)
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- Infinite Biomedical Technologies
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Principal investigator, Rahul Kaliki, Infinite Biomedical Technologies
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04043234
- Sponsor's protocol ID
- U44NS108894
- Acronym
- RESCU
- Status last verified
- Apr 2024
- First submitted
- 31 Jul 2019
- Last updated
- 24 Apr 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- User-driven Retrospectively Supervised Classification Updating (RESCU) System for Robust Upper Limb Prosthesis Control
- ClinicalTrials.gov ID
- NCT04043234
- Acronym / sponsor ID
- RESCU / U44NS108894
- Conditions
- Amputation, Upper Limb
- Keywords
- upper limb, amputation, prosthesis, myoelectric, pattern recognition
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 4 participants (actual)
- Lead sponsor
- Infinite Biomedical TechnologiesIndustry (pharma, biotech, devices)
- Study start
- 7 Nov 2023 (actual)
- Primary completion
- 19 Dec 2023 (actual)
- Study completion
- 19 Dec 2023 (actual)
- First posted
- 2 Aug 2019 (actual)
- Results
- Posted 24 Apr 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will compare the use of RESCU [Experimental] Prosthesis with a [Standard] pattern recognition prosthesis in a clinical setting and in unsupervised daily activity. The protocol will follow a single case experimental design (SCED) to compensate for the limited size of the patient population. Each of the participants will use the Standard and Experimental and systems over a 35-day period. The Standard system will include at least two controllable DoFs (hand, wrist, multi-articulated hand, etc) and a commercially-available pattern recognition controller. The RESCU system will use the same components as the Standard system but will differ with respect to incorporating eight IBT Element Electrodes (as required for pattern recognition control) and the RESCU control software. The hypothesis is that pattern recognition will outperform the commercially-available control strategy for most participants on in-clinic, at-home usage, and subjective measures.
Detailed description
The AB sequence for the study protocol is described below, where control type A is the Standard prosthesis and control type B is the Experimental prosthesis.
On Day 0, the participant will be evaluated with the Standard prosthesis. A series of Measures (as defined in the next paragraph) will then be recorded. The participant will then take the prosthesis home for one week, and daily use data will be recorded. The participant will return to the clinic for Day 7 Measures and download of the daily use data. During this session, the participant will be fit with the second system, undergo occupational therapy in the clinic, and Measures will be recorded. There will be no washout period as the prosthesis is expected to be in daily use. The participants will go home for a four-week period and return on Day 35 for a third set of Measures. At this time, the participant will be asked which prosthesis he/she prefers.
There are limited functional outcome assessment options for the planned comparison. However, the investigators will test functional measures at the clinic appointments, examine daily use data, and administer several qualitative surveys to assess participant outcomes.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single-Case Experimental Design (SCED)
| Arm | Type | Receives |
|---|---|---|
| Single-Case Experimental Design | Experimental | Device: RESCU, Device: Pattern RecognitionParticipants act as their own controls. They first use the Control device, which includes the pattern recognition controller, 8 electrodes, batteries, socket, frame, and prosthesis terminal device (hand/wrist/elbow). Participants are then transitioned to the Experimental device, which includes the RESCU controller, Apple iPad, 8 electrodes, batteries, socket, frame, and prosthesis terminal device (hand/wrist/elbow). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Trans-radial limb difference.
- Candidate for a 2+ degree-of-freedom (DoF) myoelectric pattern recognition prosthesis as determined by the study prosthetist
- Active pattern recognition myoelectric prosthesis user
- Fluent in English
- Age of 18 years or greater
Key exclusion criteria (8 listed)
- Patients with a residual limb that is unhealed from the amputation surgery
- Patients with easily damaged or sensitive skin who would not tolerate EMG electrodes
- Unhealed wounds
- Significant cognitive deficits as determined upon clinical evaluation
- Significant neurological deficits as determined upon clinical evaluation
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 |
|---|---|---|
| RESCURetrospectively Supervised Classification Updating (RESCU) is founded on two innovations that promise significant improvement in performance and outcome. The first is a highly robust machine intelligence algorithm, an Extreme Learning Machine with Adaptive Sparse Representation (EASRC), and the second is a novel adaptive learning algorithm and communication interface we call Nessa. We contend that these two technologies allow the prosthetic device to adapt to its user from the initial fitting through continuing, long-term use in the activities of daily living, shifting the paradigm of training from the current prospective data gathering methods to a more dynamic retrospective application. | Device | Single-Case Experimental Design |
| Pattern RecognitionPattern recognition prostheses associate the patterns of activity of multiple EMG sites to the action of a prosthesis. Such strategies have historically required prospective calibration of the EMG activation patterns. | Device | Single-Case Experimental Design |
Primary outcome
Mean Daily Prosthesis Use Duration
Time frame: Baseline, 4 weeks
Prosthesis usage time was monitored as a proxy for user satisfaction, under the assumption that when an individual is more satisfied with their prosthetic solution, they will use it more in their daily lives. For the experimental intervention, the mean daily prosthesis use duration is reported as the average number of hours the prosthesis was used daily over the evaluation period (i.e., four weeks). For the control intervention, the mean daily prosthesis use duration is reported as the average number of hours the prosthesis was used daily before the evaluation period (i.e., at baseline).
7 secondary outcomes
Activities Measure for Upper Limb Amputees (AM-ULA)
Time frame: Baseline, Post-Fitting, Post-Intervention
Orthotics and Prosthetics User's Survey Upper Extremity Functional Status (OPUS UEFS)
Time frame: Baseline, Post-Intervention
Trinity Amputation and Prosthesis Experience Survey for Upper Limb Amputation (TAPES-ULA)
Time frame: Baseline, Post-Intervention
PROMIS Satisfaction Short Form 8a
Time frame: Baseline, Post-Intervention
Pain Scale
Time frame: Baseline, Post-Fitting, Post-Intervention
Socket Comfort Score
Time frame: Baseline, Post-Fitting, Post-Intervention
Range of Motion (of Residual Joints)
Time frame: Baseline, Post-Fitting
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing RESCU and Pattern Recognition in people with Amputation and Upper Limb, run by Infinite Biomedical Technologies 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 5 inclusion and 8 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 Apr 2024. 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?
Yes. Results are posted in the registry (first posted 24 Apr 2024). 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?
Mean Daily Prosthesis Use Duration (time frame: Baseline, 4 weeks). 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 24 Apr 2024.