Regulatory Clearance of the Glide Control Strategy for Upper Limb Prostheses

Description

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.

Conditions

Amputation, Upper Limb

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Study Overview

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Study Details

Study overview

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.

Regulatory Clearance of the Glide Control Strategy for Upper Limb Prostheses

Regulatory Clearance of the Glide Control Strategy for Upper Limb Prostheses

Condition
Amputation
Intervention / Treatment

-

Contacts and Locations

Redondo Beach

Advanced Arm Dynamics, Redondo Beach, California, United States, 90277

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • * 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

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Infinite Biomedical Technologies,

Study Record Dates

2026-03-31