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Prosthetic Device

Prosthetic Wrist Device for Amputation

N/A
Waitlist Available
Led By Levi Hargrove
Research Sponsored by Shirley Ryan AbilityLab
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
A unilateral upper limb amputation or absence below the elbow
Ages 18-95
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline and 8 weeks for condition a; baseline and 8 weeks for condition b
Awards & highlights

Study Summary

This trial will compare how well people with a one- vs. two-jointed arm prosthesis can perform tasks, using a standard hand and control system.

Who is the study for?
This trial is for English-speaking adults aged 18-95 with a single upper limb amputation below the elbow. Participants must be able to wear a prosthesis and perform daily tasks. Those with new injuries, cognitive impairments that affect study compliance or understanding, or other serious health issues cannot join.Check my eligibility
What is being tested?
The study compares the functionality of different wrist prostheses in individuals with transradial amputations: one with a single degree of freedom (1-DOF) and another with two degrees of freedom (2-DOF). It measures how well these devices work during lab tests and everyday home use.See study design
What are the potential side effects?
While specific side effects are not detailed for this device trial, participants may experience discomfort or skin issues related to wearing the prosthesis. There could also be challenges in adapting to using the device during daily activities.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have one arm amputated or missing below the elbow.
Select...
I am between 18 and 95 years old.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline and 8 weeks for condition a; baseline and 8 weeks for condition b
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline and 8 weeks for condition a; baseline and 8 weeks for condition b for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Academy of Prosthetics and Orthotics ULPOM committee toolkit of outcome measures to record change of prosthetic performance
Secondary outcome measures
Assessment of Capacity for Myoelectric Control (ACMC)
Clothespin Relocation Test
Jebsen-Taylor Hand Function Test
+5 more

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Home Trial Condition BExperimental Treatment1 Intervention
Subject will use at pattern recognition controlled prosthesis that includes a powered wrist rotation, powered flexion/extension and a single DOF powered hand.
Group II: Home Trial Condition AActive Control1 Intervention
Subject will use a pattern recognition controlled prosthesis that includes a powered wrist rotation, passive wrist flexion/extension, and a single DOF powered hand.

Find a Location

Who is running the clinical trial?

Shirley Ryan AbilityLabLead Sponsor
192 Previous Clinical Trials
14,871 Total Patients Enrolled
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)NIH
1,952 Previous Clinical Trials
2,660,830 Total Patients Enrolled
Levi HargrovePrincipal Investigator - Shirley Ryan AbilityLab
Shirley Ryan AbilityLab

Media Library

Commercially available device (Prosthetic Device) Clinical Trial Eligibility Overview. Trial Name: NCT04069793 — N/A
Wrist Amputation Research Study Groups: Home Trial Condition B, Home Trial Condition A
Wrist Amputation Clinical Trial 2023: Commercially available device Highlights & Side Effects. Trial Name: NCT04069793 — N/A
Commercially available device (Prosthetic Device) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04069793 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is enrollment for this study still open to volunteers?

"The relevant clinicaltrials.gov page confirms that this medical experiment is enrolling new participants, with the initial posting dating back to January 18th 2018 and most recent update being November 14th 2022."

Answered by AI

Is participation in this research limited to individuals younger than 85 years of age?

"This research study is open to any individual between the ages of 18 and 95. Furthermore, 1 trial for minors under 18 and 73 studies for seniors above 65 are also available."

Answered by AI

Could I be a potential candidate for this research endeavor?

"This clinical trial requires applicants to have sustained a traumatic amputation and be aged between 18 and 95. The study is looking for 14 volunteers in total."

Answered by AI

How many participants are being recruited for this experiment?

"Affirmative, the information uploaded to clinicaltrials.gov attests that recruitment is ongoing for this medical trial. It was originally published on January 18th 2018 and had its most recent update November 14th 2022. The study requires 14 participants to attend one site."

Answered by AI
~1 spots leftby Sep 2024