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Prosthetic Device
Proprio Foot for Amputation (OPORP Trial)
N/A
Waitlist Available
Led By Sashwati Roy, PhD
Research Sponsored by Indiana University
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 4 weeks
Awards & highlights
OPORP Trial Summary
This trial is measuring the effects of powered prosthetic legs on the user's health and socket loading.
Eligible Conditions
- Amputation
- Prosthesis Durability
- Dermabrasion
- Limited Mobility
- Pressure Sore
- Foot Amputation
- Limb Deficiencies
- Prosthesis User
OPORP Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 4 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~4 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Effects of use of a powered transtibial prosthesis on socket pressure
Secondary outcome measures
Change in PEQ-13 Score
Change in Skin Perfusion
Change in transepidermal water loss
+1 moreOPORP Trial Design
2Treatment groups
Active Control
Group I: Proprio FootActive Control1 Intervention
microprocessor-controlled prosthesis that regulates the angle of ankle dorsiflexion during the swing phase
Group II: Empower AnkleActive Control1 Intervention
a powered prosthesis that provides active propulsion in late stance to mimic the positive work performed by the ankle plantar-flexors in push-off. The Empower has been shown to improve affected leg kinematics (increased ankle range of motion and reduced knee flexion) on smooth flat ground, ramp ascent, and gravel
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Who is running the clinical trial?
Indiana UniversityLead Sponsor
980 Previous Clinical Trials
983,155 Total Patients Enrolled
United States Department of DefenseFED
861 Previous Clinical Trials
227,188 Total Patients Enrolled
University of Notre DameOTHER
33 Previous Clinical Trials
61,588 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have difficulties with memory, thinking, or mental health that would make it hard for you to understand and fully participate in the study.Your remaining limb after amputation is longer than 4.5 inches.You have certain health conditions or other problems that would make it difficult for you to wear a prosthetic limb, walk normally, or use your other leg effectively.People who have had a limb amputated.You have been diagnosed with kidney failure.You have had one leg amputated below the knee.You are currently using a non-electronic prosthetic limb.
Research Study Groups:
This trial has the following groups:- Group 1: Proprio Foot
- Group 2: Empower Ankle
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.
How many participants have been authorized to take part in this research?
"Affirmative. Clinicaltrials.gov's records show that this trial, which was posted on November 15th 2021, is presently searching for participants. 13 subjects need to be found at a single site."
Answered by AI
Are there still openings available for individuals to join this experiment?
"Affirmative. The information hosted on clinicaltrials.gov suggests that this study is actively searching for participants since its initial posting in November 2021 and most recent update in February 2022. A total of 13 individuals are required to be recruited from a single clinic location."
Answered by AI
Who else is applying?
What state do they live in?
Indiana
How old are they?
18 - 65
What site did they apply to?
Indiana University Health Methodist Hospital
What portion of applicants met pre-screening criteria?
Met criteria
How responsive is this trial?
Typically responds via
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