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Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Able to walk independently
Age 18 or over
Timeline
Screening 3 weeks
Treatment Varies
Follow Up during a single intervention visit (study visit 2), up to 2-3 hours in duration.
Awards & highlights
Study Summary
This trial will investigate how people with vision impairment adjust their gait when stepping over obstacles of different heights and contrasts to the ground, in order to help prevent falls.
Who is the study for?
This trial is for adults over 18 who can walk on their own. It's for those with normal vision or impaired vision, defined as having a visual acuity of 20/25 or worse, possibly with central scotoma, or a restricted field of view. People not allowed include those advised against moderate exercise by doctors, have vestibular disorders or deafness, conditions affecting long walks, cognitive issues (scoring below 24 out of 30 on the Mini Mental State Exam), gait abnormalities from injuries or diseases like Parkinson's, and non-English speakers.Check my eligibility
What is being tested?
The study tests how adults with vision impairment adjust their walking when they encounter obstacles that differ in height and contrast to the ground. The goal is to understand how these individuals use their gaze and change their gait to navigate safely and potentially reduce fall risks.See study design
What are the potential side effects?
There are no medicinal side effects involved in this trial since it does not involve drugs; however participants may experience physical fatigue due to walking exercises during the study.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I can walk on my own without help.
Select...
I am 18 years old or older.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ during a single intervention visit (study visit 2), up to 2-3 hours in duration.
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~during a single intervention visit (study visit 2), up to 2-3 hours in duration.
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Foot placement variability
Gaze sequencing
Obstacle crossing speed
+1 moreTrial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Low Vision GroupExperimental Treatment1 Intervention
At a single study visit, the group of low vision participants will be asked to perform a series of short walking trials. During each trial they will walk at a self-selected speed along a walkway (6 meters in length) that may or may not contain an obstacle to step over. The trials will be randomly varied with regard to an obstacle's presence, height, and contrast from the walkway surface. Repeated trials of each condition variation will be performed during the visit.
Group II: Control GroupActive Control1 Intervention
At a single study visit, the group of age-matched participants without low vision will be asked to perform a series of short walking trials. During each trial they will walk at a self-selected speed along a walkway (6 meters in length) that may or may not contain an obstacle to step over. The trials will be randomly varied with regard to an obstacle's presence, height, and contrast from the walkway surface. Repeated trials of each condition variation will be performed during the visit.
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Who is running the clinical trial?
Indiana UniversityLead Sponsor
980 Previous Clinical Trials
981,562 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I have a history of balance issues or deafness.I can walk on my own without help.I can walk for up to 2 hours with breaks without feeling dizzy, chest pain, or shortness of breath.I am not cleared for moderate exercise by a doctor.I need help to walk, like a cane or oxygen tank.I am 18 years old or older.I have difficulty walking due to an injury, surgery, arthritis, or a condition like Parkinson's.You have trouble thinking or remembering things, or you scored less than 24 on a memory test.I do not speak English.You can see normally, or you have impaired vision, meaning your eyesight is 20/25 or worse with or without a central blind spot, and your field of vision is limited to an average of 100 degrees or less.People in the control group need to have good eyesight, with a visual acuity of 20/40 or better.
Research Study Groups:
This trial has the following groups:- Group 1: Low Vision Group
- Group 2: Control Group
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 extensive is the scope of this clinical trial in regards to participants?
"Correct. According to clinicaltrials.gov, the medical trial first announced on April 14th 2023 is currently accepting patients with 150 participants sought from a single site."
Answered by AI
Are any new participants needed for this clinical experiment?
"Affirmative. According to clinicaltrials.gov, this investigation is still actively seeking volunteers with the initial post being made on April 14th 2023 and last updated on May 25th 2023. 150 individuals are required at 1 medical site for enrolment into the study."
Answered by AI
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