Regulatory Clearance of the Glide Control Strategy for Upper Limb Prostheses

NCT06539936 | Recruiting DMC FDA Device

• 1 other identifier: R44HD090811
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 1

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

Keywords

amputation; upper limb; myoelectric control; prosthesis; glide

Outcome Measures

Primary Outcomes (1)

• Comprehensive Arm Prosthesis and Rehabilitation Outcomes Questionnaire (CAPROQ)

  CAPROQ is a validated patient reported outcome measure that captures key facets of rehabilitation for adults with UL absence or loss: perceived function, satisfaction, and pain. CAPROQ includes a total of 28 questions spread across three sub-scales: 8 satisfaction, 10 perceived functioning, and 10 pain subcategory questions. Responses to all questions are given on a 10-point, Likert-type scale. Higher scores therefore indicate higher levels of overall satisfaction. A singular total CAPROQ score is derived by standardizing each of the CAPROQ subscales and summing these standardized scores together. Higher total scores on the CAPROQ indicate better rehabilitation outcomes and reflect the individual's perceived success with their prosthesis and rehabilitation; specifically, satisfaction with their prosthesis and rehabilitation, greater functional performance, and lesser pain. CAPROQ scores range from 0 to 100.

  Weekly (i.e., Day 0, Day 7, Day 14, ..., Day 161 and Day 168)

Secondary Outcomes (7)

• Capacity Assessment of Prosthesis Performance of the Upper Limb (CAPPFUL)

  Baseline (i.e., Day 0); Post-Intervention (i.e., Day 35/42/49, Day 70/84/98, Day 119/126/133, and Day 168)

• Targeted Box and Blocks Tests (tBBT)

  Baseline (i.e., Day 0); Post-Intervention (i.e., Day 35/42/49, Day 70/84/98, Day 119/126/133, and Day 168)

• Daily Mean Number of Movement Bouts (DMNMB)

  Daily (i.e., Day 0, Day 1, Day 2, ..., Day 167, Day 168)

• Mean Prosthesis Wear Duration (MPWD)

  Daily (i.e., Day 0, Day 1, Day 2, ..., Day 167, Day 168)

• FIT Survey

  Weekly (i.e., Day 0, Day 7, Day 14, ..., Day 161, and Day 168)

Study Arms (1)

Multiple Baseline

EXPERIMENTAL

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.

Device: Glide; Device: Direct Control

Interventions

Glide DEVICE

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.

Multiple Baseline

Direct Control DEVICE

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).

Multiple Baseline

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Infinite Biomedical Technologies: lead
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator
• Advanced Arm Dynamics: collaborator

Study Sites (1)

Advanced Arm Dynamics

Redondo Beach, California, 90277, United States

RECRUITING

Central Study Contacts

Rahul R Kaliki, Ph.D

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief Executive Officer

Model Details: Single-Case Experimental Design (SCED)

Study Record Dates

• First Submitted: May 6, 2024
• First Posted: August 6, 2024
• Study Start: September 16, 2024
• Primary Completion: March 31, 2026
• Study Completion: March 31, 2026
• Last Updated: March 24, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)