Regulatory Clearance of the Glide Control Strategy for Upper Limb Prostheses

Infinite Biomedical Technologies

Status: Enrolling

Conditions: Upper Limb; Amputation

Treatments: Device: Direct Control; Device: Glide

Study type: Interventional

Funder types: Industry; Other; NIH

Identifiers

NCT06539936

R44HD090811 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full description

Recruitment and group assignment: Participants will be recruited through one of Arm Dynamics's six Centers of Excellence. Potentially eligible participants will be identified by their care team and referred to a study team member to go over the details of the patient's involvement and the study protocol. After informed consent and medical clearance are completed, the study prosthetist and occupational therapist will meet with the participant and identify functional goals for their prosthesis. The prosthetist will then begin fabricating the prosthesis. A single prosthesis will be fabricated for use with both control strategies. Switching between control methods will be done through the Glide iPad application. Once fabrication is completed, a clinical team member will configure the assigned control strategy with the subject to achieve maximum functional efficiency.

Prosthesis delivery and occupational therapy (Day 0): After the consenting process and group assignment, patients will return to the clinic to be fit with the prosthesis. Each prosthetic system will include IBT's Glide system, remote electrodes, FlexCell batteries, and prosthetic componentry chosen by the patient and their clinical team. The Glide system also allows for Direct Control of the prosthesis without any hardware change, as long as two of the remote electrodes are positioned according to Direct Control site selection. The fitting process may take multiple visits to adjust the socket. The participant will be given instructions on how to use their prosthesis and activate the various functions of their initial device. Occupational therapy (OT) will be provided over 2 days to the patient to help patients accomplish their desired activities of daily living. At the conclusion of OT, participants will complete baseline assessments of the CAPPFUL, tBBT, CAPROQ, FIT, DASH, and SAM measures.

Phase I DC prosthesis: Over the course of the next 5-, 6-, or 7-weeks, subjects will use their DC prosthesis during their everyday lives. The Glide system is capable of recording usage data during these at-home periods (regardless of which control system is active at a given time). These measures include the Daily Mean Number of Movement Bouts (DMNMB). Using a web portal submission, subjects will report the DMNMB and their Mean Prosthesis Wear Duration (MPWD) for the previous week. At this time, subjects will also complete the CAPROQ and FIT surveys. This data submission will occur weekly.

Phase I Midpoint: Subjects will return to the clinic where they will first complete CAPPFUL, tBBT, CAPROQ, FIT, DASH, and SAM. Once completed, the subject will continue Phase I.

Phase I DC prosthesis: Phase I procedures will be repeated (DC prosthesis).

Crossover checkpoint (Day 70, 84, or 98): Subjects will return to the clinic where they will first complete CAPPFUL, tBBT, CAPROQ, FIT, DASH, and SAM. Once completed, they will have their control strategy transitioned to Glide. They will then receive OT training and complete the same measurements using their prosthesis with Glide control.

Phase II Glide prosthesis: Over the course of the next 7-, 6-, or 5-weeks, subjects will use their Glide prosthesis during their everyday lives. Using the Glide system, subjects will repeat the procedures outlined in Phase I.

Phase II Midpoint: Subjects will return to the clinic where they will first complete CAPPFUL, tBBT, CAPROQ, FIT, DASH, and SAM. Once completed, the subject will continue Phase II.

Phase II Glide prosthesis: Phase II procedures will be repeated (Glide prosthesis).

Endpoint evaluation (Day 168): Measurements from the crossover checkpoint will be made with the Glide prosthesis only. The patient will be re-fit with their pre-study prosthesis, and OT provided as necessary.

Enrollment: 7 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Trans-radial unilateral limb loss
• Candidate for a multi-articulated myoelectric hand prosthesis as determined by the study prosthetist
• Minimal residual limb length for myoelectric control as determined by the clinical team
• Age of 18 years or greater

Exclusion criteria

• 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 design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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7 participants in 1 patient group

Multiple Baseline

Experimental group

Description:

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.

Treatment:

Device: Glide

Device: Direct Control