Your session is about to expire
← Back to Search
Orthosis
Knee-Ankle-Foot Braces for Spinal Cord Injury
N/A
Recruiting
Research Sponsored by Shirley Ryan AbilityLab
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Requires orthotic bracing for lower extremity instability, including the knee joint, unilaterally or bilaterally
Aged 18-80 years
Timeline
Screening 3 weeks
Treatment Varies
Follow Up change from baseline in score after using device at 3, 6, and 12 month follow-up.
Awards & highlights
Study Summary
This trial compares two types of knee-ankle-foot braces to see which is more effective following discharge from inpatient rehab.
Who is the study for?
This trial is for adults aged 18-80 who are within 3-24 months post spinal cord injury. Participants must need lower extremity bracing, be able to charge and remember to wear devices daily, and weigh under 275 lbs. Those with unstable health conditions, severe spasticity, or significant leg length discrepancies cannot join.Check my eligibility
What is being tested?
The study compares a microprocessor-controlled knee-ankle-foot orthosis (C-Brace II) with traditional care models in people after spinal cord injury rehab. It's randomized and measures how each orthosis affects the user over a three-month period at home.See study design
What are the potential side effects?
While not explicitly stated, potential side effects may include discomfort from wearing the braces, skin issues where the brace contacts the body, and possible muscle or joint pain due to changes in movement patterns.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I need a brace for my leg or legs due to instability.
Select...
I am between 18 and 80 years old.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ change from baseline in 6mwt distance after using device at 3, 6, and 12 month follow-up.
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~change from baseline in 6mwt distance after using device at 3, 6, and 12 month follow-up.
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Six Minute Walk Test (6MWT)
Secondary outcome measures
10 Meter Walk Test (10MWT)
Berg Balance Scale (BBS)
Functional Gait Assessment (FGA)
+6 moreOther outcome measures
Actigraph
Activities Specific Balance Confidence Scale (ABC)
EQ5D-5L
+7 moreTrial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: C-Brace II GroupExperimental Treatment1 Intervention
Subjects will be assigned a C-Brace II orthotic for use.
Group II: Traditional GroupActive Control1 Intervention
Subjects will continue with their own KAFO (non C-Brace II) use.
Find a Location
Who is running the clinical trial?
Shirley Ryan AbilityLabLead Sponsor
193 Previous Clinical Trials
16,855 Total Patients Enrolled
Otto Bock Healthcare Products GmbHIndustry Sponsor
15 Previous Clinical Trials
807 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I do not have cognitive impairments that limit my participation.I cannot keep my upper body stable, even with support like a cane.I can charge and remember to wear the trial devices daily for 3 months.My body weight is over 275 lbs.I was diagnosed with a spinal cord injury between 3 to 24 months ago.I need a brace for my leg or legs due to instability.My heart, brain, or cancer condition is stable.My knee or hip cannot fully straighten, bending more than 10 degrees.My legs differ in length by more than 6 inches.I experience moderate to severe muscle stiffness.I cannot use the C-Brace tool effectively to move my legs.I am between 18 and 80 years old.My knee bends inward or outward more than 10 degrees.
Research Study Groups:
This trial has the following groups:- Group 1: C-Brace II Group
- Group 2: Traditional 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.
Does this clinical research encompass participants of all ages, including those 30 and older?
"This trial is restricted to individuals aged 18-80. However, for those below the age of majority or above retirement there are 138 and 735 other trials respectively available."
Answered by AI
What is the current capacity for participation in this medical experiment?
"Indeed, information found on clinicaltrials.gov shows that this research is actively looking for volunteers to participate. The initial posting was made back in April of 2019 and the page has been updated recently in October 2022. A total of 30 people will be recruited from one single medical facility."
Answered by AI
What are the criteria for individuals to be eligible to participate in this research?
"This clinical trial is looking for 30 patients, aged 18 to 80 years old and suffering from spinal cord injury. Additional eligibility criteria include being within 3-24 months post diagnosis and demonstrating the ability to charge assigned sensors during a three month home trial period as well as having adequate memory capability to wear devices consistently throughout orthoses usage."
Answered by AI
Recent research and studies
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger