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Prosthetic Foot-Ankle Mechanisms for Transtibial Amputation

N/A
Waitlist Available
Research Sponsored by Massachusetts Institute of Technology
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 from enrollment to the end of trial (2 sessions, 8 hours total per patient)
Awards & highlights

Study Summary

This trial will collect data to determine how different ankle-foot prostheses affect gait. Subjects will wear sensors and use prostheses while walking on level-ground, treadmill, and stairs. Data will be collected and prosthesis controllers adjusted for best gait.

Who is the study for?
This trial is for individuals aged 18-65 with a single below-knee (transtibial) amputation who are fairly to very active, as indicated by a K3 or K4 Medicare mobility rating. It's not suitable for those under 18 or over 65, or less active individuals rated below K3.Check my eligibility
What is being tested?
The study tests different prosthetic foot-ankle mechanisms: MIT's Variable Stiffness and Equilibrium Angle Prostheses, the Sliding Beam Passive Prosthesis, Ossur's Pro-flex XC, and Blatchford's Elan Variable-Dampening Prosthesis. Participants will use these while walking on various surfaces and their gait will be analyzed using sensors and motion capture.See study design
What are the potential side effects?
While there may not be traditional 'side effects' like in drug trials, participants might experience discomfort adjusting to different prosthetics. There could also be muscle strain or skin irritation at the site of prosthesis attachment.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from enrollment to the end of trial (2 sessions, 8 hours total per patient)
This trial's timeline: 3 weeks for screening, Varies for treatment, and from enrollment to the end of trial (2 sessions, 8 hours total per patient) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
User device preference for level-ground walking
User device preference for sloped ground ascent & descent
User device preference for stair ascent & descent
Secondary outcome measures
Effect of device on ground reaction force during ambulation
Effect of device on level-ground walking gait
Effect of device on sloped ground walking gait
+1 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: Unilateral Subject GroupExperimental Treatment5 Interventions
Foot-ankle devices will be given to this group to evaluate and compare the devices.

Find a Location

Who is running the clinical trial?

Massachusetts Institute of TechnologyLead Sponsor
97 Previous Clinical Trials
12,729,977 Total Patients Enrolled

Media Library

Unilateral Subject Group Clinical Trial Eligibility Overview. Trial Name: NCT05964855 — N/A
Transtibial Amputation Research Study Groups: Unilateral Subject Group
Transtibial Amputation Clinical Trial 2023: Unilateral Subject Group Highlights & Side Effects. Trial Name: NCT05964855 — N/A
Unilateral Subject Group 2023 Treatment Timeline for Medical Study. Trial Name: NCT05964855 — N/A

Frequently Asked Questions

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

Are adolescents within the age range of this investigation?

"The age restriction for this trial is 18 years and over, with an upper limit of 65."

Answered by AI

Are there any vacancies for this clinical experiment currently available?

"Clinicaltrials.gov does not list this clinical trial as actively recruiting. The first posting was on July 28th 2023, and the last edit occurred 10 days later on July 19th 2023. Nonetheless, there are presently multiple other medical studies that need new patients."

Answered by AI

What are the main goals of this clinical research?

"This trial will monitor the primary outcome of user preference for stair ascent and descent over a period of 8 hours, spread out across two separate sessions. Secondary outcomes include evaluations on sloped walking gait patterns utilizing Vicon motion capture technology, ground reaction forces during ambulation using Bertec force plates in Newtons, as well as assessing gait symmetry with regards to stair negotiation."

Answered by AI

Who is eligible to take part in this research project?

"To qualify for the trial, subjects must be between 18 and 65 with a transtibial amputation. The team is currently seeking out 10 potential participants."

Answered by AI

Who else is applying?

What site did they apply to?
MIT Media Laboratory
What portion of applicants met pre-screening criteria?
Met criteria
Recent research and studies
clinicaltrials.govStudy
Comparison of Various Prosthetic Foot-Ankle Mechanisms
2023. "Comparison of Various Prosthetic Foot-Ankle Mechanisms". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05964855.
~2 spots leftby Jul 2024
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