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Uneven Terrain Walking for Amputees
N/A
Recruiting
Led By Jenny A Kent, PhD
Research Sponsored by University of Nevada, Las Vegas
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 during training session on days 1 and 2 (each up to 45 minutes)
Awards & highlights
Study Summary
This trial aims to find out if walking on an uneven surface can help people with lower limb amputations improve balance, adapt to different walking contexts and gain confidence.
Who is the study for?
This trial is for people with lower limb amputation at ankle level or above, who regularly use a walking prosthesis and can walk for two minutes. They should have a good socket fit and be willing to travel to the test site twice. It's not for those with acute illness, leg pain during weight-bearing, dizziness, severe health conditions that limit activity, pregnancy, cognitive issues or allergies to medical adhesives.Check my eligibility
What is being tested?
The study compares the effects of gait practice on an uneven terrain surface versus a flat terrain surface in improving balance and confidence in using prosthetics. The goal is to see if practicing on uneven surfaces helps people adapt better when walking in different environments.See study design
What are the potential side effects?
While specific side effects are not listed for this type of physical therapy intervention, participants may experience increased muscle soreness or fatigue due to unfamiliar exercise. There might also be a risk of falls while navigating uneven surfaces.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ during training session on days 1 and 2 (each up to 45 minutes)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~during training session on days 1 and 2 (each up to 45 minutes)
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in balance self-efficacy from baseline
Limb structure
Secondary outcome measures
Change from baseline in average step length during level walking
Change from baseline in average step width during level walking
Change from baseline in average walking speed
+3 moreOther outcome measures
Assessment protocol feasibility assessed by ability to take two steps or more on narrow beam
Protocol acceptability assessed by session duration
Training protocol acceptability assessed by training acceptability questionnaire
+2 moreTrial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Uneven terrain walking trainingExperimental Treatment1 Intervention
Participants will complete walking practice on an uneven terrain surface.
Group II: Flat terrain walkingActive Control1 Intervention
Participants will complete walking practice on a level surface.
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Who is running the clinical trial?
University of Nevada, Las VegasLead Sponsor
66 Previous Clinical Trials
13,789 Total Patients Enrolled
Jenny A Kent, PhDPrincipal InvestigatorUniversity of Nevada, Las Vegas
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have a wound or sore on your leg or foot that hurts when you put weight on it.You are currently experiencing a severe illness.You have had your foot or leg amputated at or above the ankle.You have serious medical issues that prevent you from doing moderate physical activity.You have been diagnosed with problems related to thinking or memory.You are allergic to medical tape or bandages.Your prosthetic limb fits well and feels comfortable, with a score of 7-10 on the socket fit comfort score.You feel dizzy on the day of testing.You are missing one or both of your arms at or above the wrist.
Research Study Groups:
This trial has the following groups:- Group 1: Uneven terrain walking training
- Group 2: Flat terrain walking
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.
What primary goals are the researchers attempting to accomplish with this clinical trial?
"This study seeks to measure the primary outcome of change in balance self-efficacy over a two day period. As secondary outcomes, data will be collected on narrow beam walking distance, horizontal ladder completion time, and average step width during level walking."
Answered by AI
To what extent is this research program limited in terms of participant capacity?
"That is right. Clinicaltrials.gov has verified that the trial, which was first issued on July 1st 2022, is actively recruiting participants at this time. The team needs to sign up 10 patients from one site."
Answered by AI
Are individuals being enrolled in this research endeavor at the present time?
"Affirmative. The data hosted on clinicaltrials.gov verifies that this medical research project, which was first published on July 1st 2022, is currently in search of participants. Around 10 patients need to be recruited from a single centre."
Answered by AI
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