Long-Term Stability of the Glide Control Strategy

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorInfinite Biomedical Technologies

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Crossover

Treatments tested in this trial

  • Glide Control System

    Device

    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 System

    Device

    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.

Treatment groups

12 Participants
are divided into 2 treatment groups
Group A: Glide then Pattern RecognitionExperimental treatment 2 interventions
Group B: Pattern Recognition then GlideExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

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.

Time frame
Weekly, From Prosthesis Delivery (Day 0) to the End of Treatment (Day 168)
2

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.

Time frame
Weekly, From Prosthesis Delivery (Day 0) to End of Treatment (Day 168)

Secondary outcomes

1

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.

Time frame
Weekly, From Prosthesis Delivery (Day 0) to End of Treatment (Day 168)
2

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.

Time frame
Weekly, From Prosthesis Delivery (Day 0) to End of Treatment (Day 168)
3

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.

Time frame
Weekly, From Prosthesis Delivery (Day 0) to End of Treatment (Day 168)
4

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.

Time frame
Weekly, From Prosthesis Delivery (Day 0) to End of Treatment (Day 168)

Other outcomes

Sponsors and contacts

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Infinite Biomedical Technologies

Lead sponsor

Medical Center Orthotics and Prosthetics

Collaborator