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K-Socket-Harness for Amputees (KSH Trial)
N/A
Waitlist Available
Led By Rory A Cooper, PhD
Research Sponsored by VA Office of Research and Development
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 30 minutes
Awards & highlights
KSH Trial Summary
This trial will improve upon and investigate the potential validity of a new transradial socket and harness design for amputees, using advanced athletic shoe technology. Five experienced Veterans will help design and fit the system, then 20 Veterans will test it for comfort, function, and load bearing failure.
Who is the study for?
This trial is for Veterans with a single below-elbow amputation who have used any prosthetic arm for at least one year, or five years for early phases. They must have a residual limb of at least 4 inches long but short enough to allow 1.5 inches clearance from a fitted wrist device.Check my eligibility
What is being tested?
The study tests the K-Socket-Harness (KSH) system, which uses advanced shoe technology for better fit and function in prosthetic arms. It involves design collaboration with Veterans, digital fitting tools, and evaluation through tasks assessing comfort and functionality.See study design
What are the potential side effects?
While specific side effects are not detailed, potential issues may include discomfort due to improper fit, skin irritation from new materials used in the socket-harness system, or challenges adapting to the novel design.
KSH Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 30 minutes
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~30 minutes
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Distance rowed in meters
Donning/doffing prosthesis
Elbow range of motion in flexion/extension
+5 moreSecondary outcome measures
Orthotics and Prosthetics User Survey (OPUS)
Participant preference
Socket Comfort Scores (SCS) on a scale from 0-10
+2 moreKSH Trial Design
2Treatment groups
Experimental Treatment
Group I: Verify performance gains for the innovative KSH system that can be delivered to Veterans. The new deExperimental Treatment1 Intervention
The investigators will perform several functional tests of the both the KSH system and the standard of care prosthesis: tensile static load bearing capacity before failure, test rowing ergometer 10-minute test before failure measured using strokes per minute, power in Watts, distance in meters, maximal force, and time before failure, range of motion in flexion/extension, and donning/doffing time.
Group II: Verify functionality of the KSH system through testing with end-users.Experimental Treatment1 Intervention
The investigators will use System Usability Scale (SUS) to assess high usability with setup and operation of the device. The investigators will assess Comfort Scores (SCS), evaluate weight and correlate it with user satisfaction. The investigators will report selection outcome between new design and current design. The investigators will asses 1) functional status, (2) health- related quality of life, and (3) satisfaction with services and (4) device scores through the Orthotics and Prosthetics User Survey (OPUS).
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Who is running the clinical trial?
Stumpworx LLCUNKNOWN
VA Office of Research and DevelopmentLead Sponsor
1,609 Previous Clinical Trials
3,306,578 Total Patients Enrolled
Rory A Cooper, PhDPrincipal InvestigatorVA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA
3 Previous Clinical Trials
73 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- My residual limb is at least 4 inches long.My residual limb is shorter than 4 inches.I have used a prosthetic for at least 5 years.I have used a prosthetic for at least 1 year.I don't have open wounds or conditions that stop me from wearing a prosthetic.My residual limb allows for more than 1.5 inches clearance from a fitted wrist.I have had one arm amputated at or above the wrist.My residual limb allows for at least 1.5 inches clearance from a fitted wrist.
Research Study Groups:
This trial has the following groups:- Group 1: Verify performance gains for the innovative KSH system that can be delivered to Veterans. The new de
- Group 2: Verify functionality of the KSH system through testing with end-users.
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is there a process in place for enrolling new participants into this experiment?
"The clinicaltrials.gov registry suggests that this particular trial, which was initially established on October 1st 2024 and last edited August 4th 2023, is not currently enrolling patients. However, there are other studies actively searching for participants at the time of writing."
Answered by AI
What are the core aims of this clinical evaluation?
"The primary outcome of this experiment, to be measured over a period of twenty minutes, is the range of motion in elbow flexion and extension. Secondary outcomes include Socket Comfort Scores (SCS) on a scale from 0-10, weight of device in pounds and participant preference. Participants will rate their comfort with an 11 point scale ranging from '0' being very uncomfortable to '10' being extremely comfortable. They will also report which prosthesis they prefer using."
Answered by AI
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