RECRUITING

Regulatory Clearance of the Glide Control Strategy for Upper Limb Prostheses

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

Regulatory Clearance of the Glide Control Strategy for Upper Limb Prostheses

Quick Facts

Study Start:2024-08
Study Completion:2026-03-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06539936

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.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Trans-radial unilateral limb loss
  2. * Candidate for a multi-articulated myoelectric hand prosthesis as determined by the study prosthetist
  3. * Minimal residual limb length for myoelectric control as determined by the clinical team
  4. * Age of 18 years or greater
  1. * Patients with a residual limb that is unhealed from the amputation surgery
  2. * Patients with easily damaged or sensitive skin who would not tolerate EMG electrodes
  3. * Unhealed wounds
  4. * Significant cognitive deficits as determined upon clinical evaluation
  5. * Significant neurological deficits as determined upon clinical evaluation
  6. * Significant physical deficits of the residual limb impacting full participation in the study as determined upon clinical evaluation
  7. * Uncontrolled pain or phantom pain impacting full participation in the study as determined upon clinical evaluation
  8. * Serious uncontrolled medical problems as judged by the project therapist

Contacts and Locations

Study Contact

Rahul R Kaliki, Ph.D
CONTACT
(443) 451-7175
rahul@i-biomed.com

Study Locations (Sites)

Advanced Arm Dynamics
Redondo Beach, California, 90277
United States

Collaborators and Investigators

Sponsor: Infinite Biomedical Technologies

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-08
Study Completion Date2026-03-31

Study Record Updates

Study Start Date2024-08
Study Completion Date2026-03-31

Terms related to this study

Keywords Provided by Researchers

  • amputation
  • upper limb
  • myoelectric control
  • prosthesis
  • glide

Additional Relevant MeSH Terms

  • Amputation
  • Upper Limb