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Prosthetic Device
Prosthetic Ankle-Foot System for Amputation
N/A
Recruiting
Led By Andrew H Hansen, 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
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, 1-month, 6-months
Awards & highlights
Study Summary
This trial will test a new prosthesis to help veterans with leg amputations wear their choice of shoes, with hopes of improving their body image & community participation.
Who is the study for?
This trial is for US military women veterans with below-knee amputations who have been using a well-fitting prosthesis for at least 6 months. They should be able to use technology for video calls and data collection, and not have severe memory or concentration issues. Those with skin problems on the residual limb, too long of a limb, over 125 kg in mass, certain neurocognitive disorders, or maxed out body image/community participation scores can't join.Check my eligibility
What is being tested?
The study tests the UNYQ Prosthetic Ankle-Feet System designed to allow veterans with leg amputations to wear various footwear. The new prosthetic foot can change shape and is made using 3D printing technology. It aims to improve satisfaction regarding fit and appearance of prostheses as well as enhance body image and community involvement.See study design
What are the potential side effects?
Since this trial involves testing a physical device rather than medication, traditional side effects are not applicable. However, participants may experience discomfort or require adjustments while getting used to the new prosthetic system.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline, 1-month, 6-months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, 1-month, 6-months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Amputation
PROMIS Ability to Participate in Social Roles and Activities (PROMIS APSRA) Change
Trial Design
1Treatment groups
Experimental Treatment
Group I: InterventionExperimental Treatment1 Intervention
Participants in this arm receive a new prosthesis system designed to improve footwear options.
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Who is running the clinical trial?
VA Office of Research and DevelopmentLead Sponsor
1,614 Previous Clinical Trials
3,305,835 Total Patients Enrolled
University of MinnesotaOTHER
1,383 Previous Clinical Trials
1,552,091 Total Patients Enrolled
Andrew H Hansen, PhDPrincipal InvestigatorMinneapolis VA Health Care System, Minneapolis, MN
2 Previous Clinical Trials
51 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- My weight is over 125 kg.I have been using a permanent prosthesis for over 6 months.I have a diagnosed condition like dementia affecting my daily activities.I have had an amputation below the knee.I am a US military veteran and identify as a woman.I have skin issues on my amputated limb.I cannot or do not want to travel to Minneapolis.
Research Study Groups:
This trial has the following groups:- Group 1: Intervention
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.
Do I meet the criteria to register for this medical trial?
"The parameters for admission into this clinical trial are an amputation and age between 18 to 89. A total of 18 participants need to be recruited."
Answered by AI
Does this research trial include geriatric participants?
"This medical trial is open to patients who are at least 18 years of age and below their 89th year."
Answered by AI
Are individuals able to enroll in the trial at this time?
"Unfortunately, this medical trial has finished recruiting. It was initially posted on July 3rd 2023 and updated lastly on October 27th 2022. Nevertheless, there are 66 other opportunities to participate in a clinical study looking for participants at present."
Answered by AI
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