Recruiting

Observational Study

Sponsor:

Infinite Biomedical Technologies

Code:

NCT06539936

Conditions

Amputation

Upper Limb

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Glide

Direct Control

Study Details

Brief summary:

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

Study ID

NCT06539936

Start date

Sep 16, 2024

Status verified date

May, 2026

Completion date

Mar 31, 2027

Anticipated

Primary completion date

Mar 31, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

7 participants

Anticipated

Intervention Model

Single group

Primary purpose

Other

Interventions and Outcome Measures

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.

Interventions

Glide

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

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).

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 and Locations

Central contacts

Rahul R Kaliki, Ph.D

(443) 451-7175rahul@i-biomed.com

Locations

Advanced Arm Dynamics

Recruiting

Redondo Beach, California, United States, 90277

Contacts

John M Miguelez, CP, FAAOP (D)

(310) 372-3050jmiguelez@armdynamics.com

More Information

Sponsor

Infinite Biomedical Technologies

Last update posted

May 29, 2026

Last verified

May, 2026

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Infinite Biomedical Technologies on 2026-05-29.