Regulatory Clearance of the Glide Control Strategy for Upper Limb Prostheses

Part of paid clinical trials in Redondo Beach, California.

Sponsor
Infinite Biomedical Technologies
Study ID
NCT06539936
Status
Recruiting
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Conditions

  • Amputation
  • Upper Limb

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Glide — DEVICE
    Glide is a myoelectric prosthesis control strategy which enables multifunctional control using a limited set of input EMG signals (as few as two). The Glide control strategy uses the relative contributions of multiple electrode inputs to create a virtual cursor, calculated from a vector summation of multiple EMG channels, to select the type and speed of a movement from a circular map.
  • Direct Control — DEVICE
    Direct Control (DC) is the most common method of control for powered prostheses, which directly links the activity recorded from a single electromyography (EMG) electrode to a prosthesis action. Typically, a pair of EMG electrodes are placed over a pair of agonist/antagonist muscle groups to operate a single DOF (e.g., for transradial amputees the flexor muscles in the forearm may be mapped to the prosthetic hand closing and the forearm extensor muscles mapped to hand opening).

Study Details

The investigators will test the following hypothesis: Use of Glide results in improved functional performance, satisfaction, and usage metrics as compared to use of a standard Direct Control (DC) prosthesis. This study will compare the use of Glide \[Experimental\] prosthesis with a DC \[Standard\] prosthesis in a clinical setting and in unsupervised daily activity. We will follow a multiple baseline design, specifically an AB design. Each of the subjects will use the Experimental and Standard systems over a total of 24-weeks. The A phase is the baseline phase where the DC prosthesis will be used, and the B phase will be the treatment phase where the Glide prosthesis will be used. Participants will undergo an A phase of either 10-weeks, 12-weeks, or 14-weeks duration, with the remaining 14-, 12-, or 10-weeks of the study being dedicated to the B phase.

Key Dates

Start date
Sep 16, 2024
Status verified
May 2026
Primary completion
Mar 31, 2027
Completion
Mar 31, 2027

Study Design

Enrollment
7 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER

Arms

  • Experimental: Multiple Baseline
    Participants act as their own controls. Participants are fit with a prosthesis system, which includes IBT's Core2 controller, IBT Electrodes, FlexCell batteries, and prosthetic componentry chosen by the patient and their clinical team. The provided controller can operate in two modes of operation: (1) in Direct Control (or DC); and (2) using the Glide control strategy. Participants progress through an AB multiple baseline protocol, where they use the provided prosthesis system for four evaluation periods (totaling 24-weeks in duration). During the A-phase, participants use the system with DC and during the B-phase, participants use the system with the Glide control strategy. For both interventions, the required hardware is the same, while the control software will differ.

Primary Outcome Measure

Comprehensive Arm Prosthesis and Rehabilitation Outcomes Questionnaire (CAPROQ) [ Time Frame: Weekly (i.e., Day 0, Day 7, Day 14, ..., Day 161 and Day 168) ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Advanced Arm DynamicsRedondo BeachCalifornia90277
John M Miguelez, CP, FAAOP (D)
[email protected]
(310) 372-3050

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Advanced Arm Dynamics· Redondo Beach, CA

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