Long-Term Stability of the Glide Control Strategy

Infinite Biomedical Technologies

Status: Enrolling

Conditions: Upper Limb Amputation Below Elbow; Upper Limb Amputation Above Elbow

Treatments: Device: Glide Control System; Device: Pattern Recognition System

Study type: Interventional

Funder types: Industry; Other

Identifiers

NCT07222085

OR240247

Details and patient eligibility

About

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.

Enrollment: 12 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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

Exclusion criteria

• 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 design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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12 participants in 2 patient groups

Glide then Pattern Recognition

Experimental group

Description:

Participants use a Glide-controlled upper limb prosthesis first, followed by a Pattern Recognition-based upper limb prosthesis.

Treatment:

Device: Pattern Recognition System

Device: Glide Control System

Pattern Recognition then Glide

Experimental group

Description:

Participants use a Pattern Recognition-based upper limb prosthesis first, followed by a Glide-controlled upper limb prosthesis.

Treatment:

Device: Pattern Recognition System

Device: Glide Control System