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Behavioural Intervention
Terrain Locomotor Training for Amputation (PROSPER Trial)
N/A
Waitlist Available
Led By Jenny A Kent, PhD, CSci
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
Fitted with a walking prosthesis and use it regularly for home and/or community ambulation
Able to walk for three minutes at a time with or without an assistive device
Must not have
Leg/foot ulcer or other conditions that cause pain during weight-bearing
Poor skin integrity that could cause tissue breakdown by walking
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through study completion, from start of recruitment period, to end of recruitment period or 30 month time point, whichever is sooner.
Awards & highlights
Summary
This trial aims to see if a walking program on uneven terrain can help people with lower limb prostheses improve their walking skills and confidence by practicing walking with varied steps in a safe environment.
Who is the study for?
This trial is for individuals with lower limb prostheses due to amputations ranging from below the knee to hip disarticulation. It aims to help them improve their walking skills and confidence on different terrains.
What is being tested?
The study tests a walking program that trains participants on uneven terrain, compared to traditional flat terrain training, in order to enhance mobility and safety for prosthesis users.
What are the potential side effects?
Since this trial involves physical training programs, potential side effects may include muscle soreness, fatigue, or falls during exercise. However, the environment will be controlled for safety.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I use a walking aid for daily activities.
Select...
I can walk for three minutes with or without help.
Select...
I have had an amputation above my ankle.
Select...
I am 18 years old or older.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have a leg or foot ulcer, or another condition that hurts when I stand or walk.
Select...
My skin is fragile and could be damaged by walking.
Select...
I have a health condition that prevents me from doing moderate exercise.
Select...
I cannot use both hands due to missing limbs above the wrist.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ through study completion, from start of recruitment period, to end of recruitment period or 30 month time point, whichever is sooner.
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through study completion, from start of recruitment period, to end of recruitment period or 30 month time point, whichever is sooner.
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Session adherence
Secondary study objectives
Activities-specific Balance Confidence Scale summary score
Activity data evaluation
Average daily activity
+11 moreTrial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Uneven terrain trainingExperimental Treatment1 Intervention
Walking on an uneven terrain treadmill or mat.
Group II: Flat terrain trainingActive Control1 Intervention
Walking on a standard, flat treadmill or mat.
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Who is running the clinical trial?
University of Nevada, Las VegasLead Sponsor
70 Previous Clinical Trials
13,953 Total Patients Enrolled
Jenny A Kent, PhD, CSciPrincipal InvestigatorUniversity of Nevada, Las Vegas
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