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Vibrotactile Device for Amputation Balance Issues
N/A
Waitlist Available
Led By Kyle R Eberlin, MD
Research Sponsored by Massachusetts General Hospital
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 one year
Awards & highlights
Study Summary
This trial tested a device to see if it could help improve balance and reduce falls in the elderly.
Who is the study for?
This trial is for English-speaking adults who have had a major lower limb amputation and are willing to participate. It's not suitable for anyone under the age of 18.Check my eligibility
What is being tested?
The study is testing a vibrotactile sensory feedback device called Saphenus, designed to help people with amputations. The goal is to determine how beneficial this device can be.See study design
What are the potential side effects?
Since the trial involves a non-invasive device, there may be minimal side effects such as skin irritation where the device attaches or discomfort from its vibrations.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ one year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~one year
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Measure Endurance
Measure Pain Intensity
Measure Pain Interference
+4 moreSecondary outcome measures
Measure Patient Anxiety
Measure Patient Depression
Measure Patient Satisfaction
Trial Design
1Treatment groups
Experimental Treatment
Group I: Patients receiving the vibrotactile sensory feedback deviceExperimental Treatment1 Intervention
Patients who have undergone a major lower limb amputation and are receiving the vibrotactile sensory feedback device
Find a Location
Who is running the clinical trial?
Massachusetts General HospitalLead Sponsor
2,928 Previous Clinical Trials
13,198,305 Total Patients Enrolled
Kyle R Eberlin, MDPrincipal InvestigatorMassachusetts General Hospital
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am younger than 18 years old.I have had a major amputation on my lower limb.I am willing and able to participate in the study.
Research Study Groups:
This trial has the following groups:- Group 1: Patients receiving the vibrotactile sensory feedback device
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 any availability for individuals to join this clinical trial?
"Affirmatively, the data on clinicaltrials.gov conveys that this particular investigation is no longer looking for participants. This trial was first put up on August 1st 2023 before being altered lastly July 17th 2023. Though recruitment has ceased for this study, there are still 75 other studies searching for volunteers right now."
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