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Prosthesis

Glide Control for Upper Extremity Amputation

N/A

Recruiting

Research Sponsored by Infinite Biomedical Technologies

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Trans-radial unilateral limb loss

Age of 18 years or greater

Must not have

Patients with a residual limb that is unhealed from the amputation surgery

Unhealed wounds

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline (i.e., day 0); post-intervention (i.e., day 35/42/49, day 70/84/98, day 119/126/133, and day 168)

Awards & highlights

No Placebo-Only Group

Summary

This trial will test if using the Glide prosthesis is better than using a standard Direct Control (DC) prosthesis in terms of performance, satisfaction, and usage. Participants will use both prost

Who is the study for?

This trial is for individuals with upper extremity amputation. Participants will use two types of prosthetic arms: a standard Direct Control (DC) prosthesis and an experimental Glide prosthesis, over a period of 24 weeks to compare functionality, satisfaction, and usage.

What is being tested?

The study aims to determine if the Glide prosthesis offers better performance than the standard DC prosthesis. Subjects will first use the DC arm for up to 14 weeks followed by the Glide arm for the remaining time in a clinical setting and daily life.

What are the potential side effects?

While specific side effects are not detailed here, potential issues may include discomfort or difficulty adapting to different control mechanisms between prostheses which could affect daily activities.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have lost one arm.

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I am 18 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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My amputation site has not fully healed.

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I have wounds that have not healed.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline (i.e., day 0); post-intervention (i.e., day 35/42/49, day 70/84/98, day 119/126/133, and day 168)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline (i.e., day 0); post-intervention (i.e., day 35/42/49, day 70/84/98, day 119/126/133, and day 168)

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline (i.e., day 0); post-intervention (i.e., day 35/42/49, day 70/84/98, day 119/126/133, and day 168) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Comprehensive Arm Prosthesis and Rehabilitation Outcomes Questionnaire (CAPROQ)

Secondary study objectives

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

Daily Mean Number of Movement Bouts (DMNMB)

Disabilities of the Arm, Shoulder and Hand (DASH) Questionnaire

+4 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Multiple BaselineExperimental Treatment2 Interventions

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Glide

2013

N/A

~20

Direct Control

2013

N/A

~20