Upper Limb Amputation Above ElbowNCT07222085
Long-Term Stability of the Glide Control Strategy
A study testing Pattern Recognition System in people with Upper Limb Amputation Above Elbow and Upper Limb Amputation Below Elbow, run by Infinite Biomedical Technologies at 10 sites in United States.
Trial summary
This research is intended to test whether the prescription of the Glide prosthesis control system reduces the burden of use for both patients and their clinical care team as compared to use of Pattern Recognition-based advanced myoelectric control. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Upper Limb Amputation Above Elbow, Upper Limb Amputation Below Elbow
- What is being tested?
- Pattern Recognition System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 10 sitesUnited States
- Study dates
- 15 Oct 2025to Apr 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Unilateral trans-radial or trans-humeral limb loss with a healed residual limb
- Candidate for 2+ degree-of-freedom (DOF) myoelectric prosthesis as determined by the study prosthetist
- Age of 18 years or greater
Who cannot join
- Prior experience with Pattern Recognition or Glide control
- Individuals with a residual limb that is unhealed from the amputation surgery
- Individuals with easily damaged or sensitive skin who would not tolerate EMG electrodes
- 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
Trial locations and contacts
10 sites in 1 country. Contact the study team or a site near you to ask about taking part.
10 sites in 1 country
United States10 sites, 10 recruiting
- Recruiting
Medical Center Orthotics and Prosthetics - Allston
Allston, Massachusetts, 02134
James Vandersea, CPO, +1 (617) 208-8468, jvandersea@mcopro.com
- Recruiting
Medical Center Orthotics and Prosthetics - Anderson
Anderson, South Carolina, 29621
James Vandersea, CPO, +1 (864) 225-1683, jvandersea@mcopro.com
- Recruiting
Medical Center Orthotics and Prosthetics - Annapolis
Annapolis, Maryland, 21401
James Vandersea, CPO, +1 (410) 573-2374, jvandersea@mcopro.com
- Recruiting
Medical Center Orthotics and Prosthetics - Baltimore
Baltimore, Maryland, 21227
James Vandersea, CPO, +1 (410) 800-4730, jvandersea@mcopro.com
- Recruiting
Medical Center Orthotics and Prosthetics - Charlotte
Charlotte, North Carolina, 28210
James Vandersea, CPO, +1 (704) 644-3636, jvandersea@mcopro.com
- Recruiting
Medical Center Orthotics and Prosthetics - Fairfax
Fairfax, Virginia, 22031
James Vandersea, CPO, +1 (703) 698-5007, jvandersea@mcopro.com
- Recruiting
Medical Center Orthotics and Prosthetics - Greenville
Greenville, South Carolina, 29615
James Vandersea, CPO, +1 (864) 676-0029, jvandersea@mcopro.com
- Recruiting
Medical Center Orthotics and Prosthetics - Leesburg
Leesburg, Virginia, 20176
James Vandersea, CPO, +1 (571) 291-3121, jvandersea@mcopro.com
- Recruiting
Medical Center Orthotics and Prosthetics - Milton
Milton, Massachusetts, 02186
James Vandersea, CPO, +1 (617) 698-6334, jvandersea@mcopro.com
- Recruiting
Medical Center Orthotics and Prosthetics - Silver Spring
Silver Spring, Maryland, 20910
James Vandersea, CPO, +1 (301) 585-5347, jvandersea@mcopro.com
About this study
Official title: Determining the Long-Term Stability of the Glide Control Strategy for Upper Limb Prostheses
This research is intended to test whether the prescription of the Glide prosthesis control system reduces the burden of use for both patients and their clinical care team as compared to use of Pattern Recognition-based advanced myoelectric control. The goal of the study is to fill the gaps in clinically relevant knowledge to inform the prescription of prosthesis components and the rehabilitation process.
- Being tested
- Glide Control System, Pattern Recognition System
- Keywords
- Glide, Pattern Recognition, Myoelectric Control, Upper Limb Prostheses
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Glide Control SystemDevice
Glide is a commercially developed directional myoelectric control strategy from Infinite Biomedical Technologies (IBT) that sits between classic Direct Control (DC) and modern Pattern Recognition (PR). Instead of requiring an isolated on/off muscle signal for each function (e.g., DC) or training a complex classifier on many gestures (e.g., PR), Glide uses the relative activity across 2-8 EMG electrodes to move a virtual cursor on a 2-D "Glide map." The map is divided into adjustable sectors ("slices"), and each slice is assigned a prosthetic movement (e.g., hand open/close, wrist rotation, elbow flexion). Moving the cursor into a slice actuates that movement.
Pattern Recognition SystemDevice
Pattern recognition (PR)-based myoelectric control is a data-driven approach that allows a user to control multiple prosthetic functions using natural muscle activation patterns rather than discrete, isolated signals. Instead of mapping one muscle to one motion (as in conventional Direct Control), PR systems record the spatial and temporal pattern of EMG activity from multiple sites on the residual limb and use machine learning algorithms to classify which intended movement the user is trying to make.
| Study group | Role | What they receive |
|---|---|---|
| Glide then Pattern Recognition | Experimental | Participants use a Glide-controlled upper limb prosthesis first, followed by a Pattern Recognition-based upper limb prosthesis. Receives: Device: Glide Control System; Device: Pattern Recognition System |
| Pattern Recognition then Glide | Experimental | Participants use a Pattern Recognition-based upper limb prosthesis first, followed by a Glide-controlled upper limb prosthesis. Receives: Device: Glide Control System; Device: Pattern Recognition System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Daily Mean Number of Control Adjustment Sessions (DMNCAS)
DMNCAS quantifies the number of times a prosthesis user needs to adjust their control strategy to maintain performance. For a PR system, a control adjustment refers to a calibration (or recalibration) of one or more prosthesis movements, while for the Glide control strategy, a control adjustment refers to a change in the Glide map configuration (e.g., electrode gains, slice geometries, assigned movements, etc.). A control adjustment session is then a period of time devoted to performing one or more control adjustments. The number and duration of control adjustment sessions will be recorded in a study diary.
Measured: Weekly, From Prosthesis Delivery (Day 0) to the End of Treatment (Day 168)
Number of Follow-Up Clinical Interventions (NFCI)
NFCI reports the number of times the prosthesis user requests the aid of a clinician to resolve an issue with their prescribed control strategy. NFCI refers to clinical interventions (both remote and in-person) that occur post-prosthesis delivery, the number and duration of which will be recorded in a study diary. Diary entries will be verified through a retrospective chart review in collaboration with Medical Center Orthotics \& Prosthetics.
Measured: Weekly, From Prosthesis Delivery (Day 0) to End of Treatment (Day 168)
Secondary outcomes (6)
Socket Comfort Score (SCS)
SCS is a validated, 11-point numerical rating scale that quantifies a respondent's subjective experience of comfort while wearing a prosthesis. The score ranges from 0 (or "the least comfortable socket fit you can imagine") to 10 (or "the most comfortable socket you can imagine"). A higher score indicates a more comfortable socket fit. Full administration of the SCS is estimated to take about 5 minutes.
Measured: Weekly, From Prosthesis Delivery (Day 0) to End of Treatment (Day 168)
Numerical Pain Rating Scale (NPRS)
NPRS is a pain screening tool that uses two 0 to 10 scales to measure pain intensity over the last seven days. The two scales interrogate different dimensions of pain: 1) residual limb pain; and 2) phantom limb pain. Both scales include descriptive anchors at the extremes (i.e., "no pain" is 0 and "the highest pain you can imagine" is 10). A higher score indicates a more intense pain experience. Full administration of the NPRS is estimated to take about 5 minutes.
Measured: Weekly, From Prosthesis Delivery (Day 0) to End of Treatment (Day 168)
PROMIS Pain Interference - Short Form 4a
PROMIS Pain Interference short form 4a is a validated, self-report questionnaire that assesses consequences of pain on relevant aspects of one's life, including the extent to which pain hinders engagement with social, cognitive, emotional, physical, and recreational activities. The assessment comprises of four, 5-point Likert-type questions, each querying the respondent on their experience of pain in the previous seven days. PROMIS instruments are scored on a T-score metric (0 - 100) in which 50 is the mean of the reference population and 10 is the standard deviation. In general, a higher score equals more of the concept being measured. For the PROMIS Pain Interference questionnaire, a higher score then indicates a greater degree to which individuals believe pain interferes with their daily lives. Full administration of the PROMIS Pain Interference short form 4a is estimated to take about 5 minutes.
Measured: Weekly, From Prosthesis Delivery (Day 0) to End of Treatment (Day 168)
PROMIS Satisfaction - Short Form 8a
PROMIS Satisfaction short form 8a is a validated, self-report questionnaire designed to query individuals on their satisfaction with their ability to participate in social roles and activities. The survey consists of eight, 5-point Likert-type questions covering several aspects of social engagement, including work, recreation, and maintaining interpersonal relationships. A higher score indicates a higher satisfaction with the respondent's ability to participate in work and home life. Full administration of the PROMIS Satisfaction short form 8a is estimated to take about 10 minutes.
Measured: Weekly, From Prosthesis Delivery (Day 0) to End of Treatment (Day 168)
OPUS Upper Extremity Functional Scale (UEFS)
OPUS UEFS is a validated, 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.). It is a low burden measure that provides a subjective view of a participant's functionality with a prosthesis. OPUS UEFS includes a total of 28 questions, each regarding an activity of daily living. Responses are divided into two parts: 1) a 5-point, Likert-type scale with descriptive anchors for each Level of Ease (e.g., "Cannot perform activity" is 0, "Very easy" is 4); and 2) an indication on if the activity is usually performed with or without a prosthesis. Participants may also provide a null response (i.e., "Not applicable") if they believe that the activity does not apply to them. The total score of the OPUS UEFS is the sum of the 28 responses converted to a Rasch measure (0 - 100). Higher scores therefore indicate greater functionality. Full administration takes about 25 minutes.
Measured: Weekly, From Prosthesis Delivery (Day 0) to End of Treatment (Day 168)
Mean Daily Prosthesis Wear Duration (MDPWD)
MDPWD acts as a proxy for improved prosthesis acceptance. Prosthesis wear time is defined as the time from when participants don their prostheses to the time they doff their prostheses. Prosthesis wear duration is self-reported (in hours) by participants via a study diary.
Measured: Weekly, From Prosthesis Delivery (Day 0) to End of Treatment (Day 168)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2025
- Study start15 Oct 2025
- Primary completionNov 2028 (estimated)
- Study completionApr 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Upper Limb Amputation Above ElbowStudies 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
- Model description
- The study participants will then be randomly block assigned to one of two groups in pair: Group AB will be prescribed a commercial Pattern Recognition (PR) system for the first Phase of the take-home evaluation and Glide for the second Phase. Group BA will be prescribed the control strategies in the inverse order, using Glide during the first Phase and a commercial PR system during the second. Within each group, participants will be again randomly assigned into one of three subgroups: AB10, AB12, and AB14 (or BA10, BA12, and BA14). These subgroups determine the duration of the first (i.e., baseline) Phase, with subgroups correlating to 10-weeks, 12-weeks, and 14-weeks.
- Masking
- None (open label)
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Infinite Biomedical Technologies
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Medical Center Orthotics and Prosthetics
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07222085
- Sponsor's protocol ID
- OR240247
- Status last verified
- Nov 2025
- First submitted
- 27 Oct 2025
- Last updated
- 5 Nov 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Determining the Long-Term Stability of the Glide Control Strategy for Upper Limb Prostheses
- ClinicalTrials.gov ID
- NCT07222085
- Acronym / sponsor ID
- OR240247
- Keywords
- Glide, Pattern Recognition, Myoelectric Control, Upper Limb Prostheses
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- Infinite Biomedical TechnologiesIndustry (pharma, biotech, devices)
- Collaborators
- Medical Center Orthotics and Prosthetics
- Study start
- 15 Oct 2025 (actual)
- Primary completion
- Nov 2028 (estimated)
- Study completion
- Apr 2029 (estimated)
- First posted
- 29 Oct 2025 (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 research is intended to test whether the prescription of the Glide prosthesis control system reduces the burden of use for both patients and their clinical care team as compared to use of Pattern Recognition-based advanced myoelectric control. The goal of the study is to fill the gaps in clinically relevant knowledge to inform the prescription of prosthesis components and the rehabilitation process.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The study participants will then be randomly block assigned to one of two groups in pair: Group AB will be prescribed a commercial Pattern Recognition (PR) system for the first Phase of the take-home evaluation and Glide for the second Phase. Group BA will be prescribed the control strategies in the inverse order, using Glide during the first Phase and a commercial PR system during the second. Within each group, participants will be again randomly assigned into one of three subgroups: AB10, AB12, and AB14 (or BA10, BA12, and BA14). These subgroups determine the duration of the first (i.e., baseline) Phase, with subgroups correlating to 10-weeks, 12-weeks, and 14-weeks.
| Arm | Type | Receives |
|---|---|---|
| Glide then Pattern Recognition | Experimental | Device: Glide Control System, Device: Pattern Recognition SystemParticipants use a Glide-controlled upper limb prosthesis first, followed by a Pattern Recognition-based upper limb prosthesis. |
| Pattern Recognition then Glide | Experimental | Device: Glide Control System, Device: Pattern Recognition SystemParticipants use a Pattern Recognition-based upper limb prosthesis first, followed by a Glide-controlled upper limb prosthesis. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Unilateral trans-radial or trans-humeral limb loss with a healed residual limb
- Candidate for 2+ degree-of-freedom (DOF) myoelectric prosthesis as determined by the study prosthetist
- Age of 18 years or greater
Key exclusion criteria (8 listed)
- Prior experience with Pattern Recognition or Glide control
- Individuals with a residual limb that is unhealed from the amputation surgery
- Individuals with easily damaged or sensitive skin who would not tolerate EMG electrodes
- 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 |
|---|---|---|
| Glide Control SystemGlide is a commercially developed directional myoelectric control strategy from Infinite Biomedical Technologies (IBT) that sits between classic Direct Control (DC) and modern Pattern Recognition (PR). Instead of requiring an isolated on/off muscle signal for each function (e.g., DC) or training a complex classifier on many gestures (e.g., PR), Glide uses the relative activity across 2-8 EMG electrodes to move a virtual cursor on a 2-D "Glide map." The map is divided into adjustable sectors ("slices"), and each slice is assigned a prosthetic movement (e.g., hand open/close, wrist rotation, elbow flexion). Moving the cursor into a slice actuates that movement. | Device | Glide then Pattern Recognition, Pattern Recognition then Glide |
| Pattern Recognition SystemPattern recognition (PR)-based myoelectric control is a data-driven approach that allows a user to control multiple prosthetic functions using natural muscle activation patterns rather than discrete, isolated signals. Instead of mapping one muscle to one motion (as in conventional Direct Control), PR systems record the spatial and temporal pattern of EMG activity from multiple sites on the residual limb and use machine learning algorithms to classify which intended movement the user is trying to make. | Device | Glide then Pattern Recognition, Pattern Recognition then Glide |
Primary outcome
Daily Mean Number of Control Adjustment Sessions (DMNCAS)
Time frame: Weekly, From Prosthesis Delivery (Day 0) to the End of Treatment (Day 168)
DMNCAS quantifies the number of times a prosthesis user needs to adjust their control strategy to maintain performance. For a PR system, a control adjustment refers to a calibration (or recalibration) of one or more prosthesis movements, while for the Glide control strategy, a control adjustment refers to a change in the Glide map configuration (e.g., electrode gains, slice geometries, assigned movements, etc.). A control adjustment session is then a period of time devoted to performing one or more control adjustments. The number and duration of control adjustment sessions will be recorded in a study diary.
Number of Follow-Up Clinical Interventions (NFCI)
Time frame: Weekly, From Prosthesis Delivery (Day 0) to End of Treatment (Day 168)
NFCI reports the number of times the prosthesis user requests the aid of a clinician to resolve an issue with their prescribed control strategy. NFCI refers to clinical interventions (both remote and in-person) that occur post-prosthesis delivery, the number and duration of which will be recorded in a study diary. Diary entries will be verified through a retrospective chart review in collaboration with Medical Center Orthotics \& Prosthetics.
6 secondary outcomes
Socket Comfort Score (SCS)
Time frame: Weekly, From Prosthesis Delivery (Day 0) to End of Treatment (Day 168)
Numerical Pain Rating Scale (NPRS)
Time frame: Weekly, From Prosthesis Delivery (Day 0) to End of Treatment (Day 168)
PROMIS Pain Interference - Short Form 4a
Time frame: Weekly, From Prosthesis Delivery (Day 0) to End of Treatment (Day 168)
PROMIS Satisfaction - Short Form 8a
Time frame: Weekly, From Prosthesis Delivery (Day 0) to End of Treatment (Day 168)
OPUS Upper Extremity Functional Scale (UEFS)
Time frame: Weekly, From Prosthesis Delivery (Day 0) to End of Treatment (Day 168)
Mean Daily Prosthesis Wear Duration (MDPWD)
Time frame: Weekly, From Prosthesis Delivery (Day 0) to End of Treatment (Day 168)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2025.
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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.
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pattern Recognition System in people with Upper Limb Amputation Above Elbow and Upper Limb Amputation Below Elbow, run by Infinite Biomedical Technologies at 10 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 3 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: looking for participants now, as of the sponsor's last update on 5 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Christopher Hunt, Ph.D (+1 443-451-7175, chris@i-biomed.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Daily Mean Number of Control Adjustment Sessions (DMNCAS) (time frame: Weekly, From Prosthesis Delivery (Day 0) to the End of Treatment (Day 168)). The study lists 2 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 5 Nov 2025.