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Powered Orthoses
Powered Orthoses for Frailty/Sarcopenia
N/A
Recruiting
Research Sponsored by University of Michigan
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Aged between 18 to 65 years
Aged between 65 to 85 years
Must not have
Significant pain due to arthritis or other joint problems that would limit their ability to walk
Prior history of chronic lower-back pain
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 day
Awards & highlights
No Placebo-Only Group
Summary
This trial is testing powered orthoses, which are devices that assist weakened joints, in order to improve function in different populations. The investigators hypothesize that the powered orthoses will help improve lifting/lowering posture in able-bodied subjects and functional outcomes in elderly subjects.
Who is the study for?
This trial is for adults under 250 lbs who can lift a weight using a specific technique or walk unassisted. It's for those aged 18-65 able to perform certain lifts and those 65-85 who can walk for six minutes. Excluded are individuals with significant pain, cognitive deficits, allergies to medical tape, recent fractures, major health conditions that affect walking, or advised against exercise by doctors.
What is being tested?
The study tests lower-limb powered orthoses designed to assist weakened joints and enhance voluntary motion in various populations. The goal is to see if these devices improve posture during lifting tasks in able-bodied subjects and functional outcomes in the elderly.
What are the potential side effects?
Potential side effects aren't specified but may include discomfort at attachment points of the orthosis, skin irritation from medical tape used on the device, muscle fatigue due to new movement patterns encouraged by the orthosis, or balance issues while adjusting to assisted movements.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am between 18 and 65 years old.
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I am between 65 and 85 years old.
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I weigh less than 250 lbs.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have severe joint pain that makes it hard for me to walk.
Select...
I have a history of chronic lower-back pain.
Select...
I do not have any major muscle or nerve conditions that would affect the study.
Select...
I have high blood pressure or diabetes that is not well-managed.
Select...
I cannot walk for 20 minutes.
Select...
I can follow simple instructions and consent to treatment.
Select...
I have had a leg or foot fracture in the last 3 months.
Select...
My mental state allows me to understand and follow simple instructions.
Select...
I have a health condition that affects my ability to walk.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 1 day
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 day
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Gait speed
Powered orthosis effect
Time to complete 10 reps of lifting/lowering
+1 moreSecondary study objectives
Thorax angle
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: ExoskeletonExperimental Treatment1 Intervention
Participants in this arm of the study will perform various tasks while wearing the modular powered orthosis
Find a Location
Who is running the clinical trial?
University of MichiganLead Sponsor
1,852 Previous Clinical Trials
6,432,709 Total Patients Enrolled
National Institute for Biomedical Imaging and Bioengineering (NIBIB)NIH
92 Previous Clinical Trials
20,209 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have severe joint pain that makes it hard for me to walk.I have a history of chronic lower-back pain.I do not have any major muscle or nerve conditions that would affect the study.I have high blood pressure or diabetes that is not well-managed.Your doctor has told you not to walk or exercise.I am between 18 and 65 years old.I cannot walk for 20 minutes.I am between 65 and 85 years old.I can follow simple instructions and consent to treatment.I have had a leg or foot fracture in the last 3 months.I weigh less than 250 lbs.My mental state allows me to understand and follow simple instructions.I don't have heart, balance, or vision problems that could affect the study.You can lift and lower a 10 kg weight using a specific squat technique for 10 times without hurting your back.I can walk for 6 minutes by myself, but I can use a walking aid if needed.You are allergic to medical tape.I have a health condition that affects my ability to walk.
Research Study Groups:
This trial has the following groups:- Group 1: Exoskeleton
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.
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