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Powered Orthosis
Powered KAFO for Mobility Impairments
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
Cognitive ability to understand and follow the study protocol; willingness to provide informed consent
Regular and compliant use of a unilateral or bilateral KAFO or SCO or other passive KAFOs for impairment due to neurological or neuromuscular disease, orthopedic disease, or trauma
Timeline
Screening 3 weeks
Treatment Varies
Follow Up during each 3 month home trial with each device.
Awards & highlights
Study Summary
This trial will measure if the Nomad powered KAFO improves mobility, balance, frequency of falls, and quality of life in people who have had a musculoskeletal or neurological injury.
Who is the study for?
This trial is for individuals with conditions like paralysis, muscular dystrophy, or spinal cord injury that affect walking. Participants must regularly use a leg brace due to their condition, be able to follow the study's instructions, and consent to wearing an activity monitor for three months.Check my eligibility
What is being tested?
The Nomad P-KAFO is being tested for its effectiveness in improving mobility and quality of life over three months compared to participants' usual braces. It involves recording daily activities with a sensor and assessing mobility using both the participant's own brace and the Nomad P-KAFO.See study design
What are the potential side effects?
While specific side effects are not listed, potential issues may include discomfort from wearing new orthotic devices, skin irritation at contact points of the device, or muscle fatigue from altered gait patterns during use.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I understand the study details and agree to participate.
Select...
I regularly use a leg brace due to a neurological, muscle, or bone condition.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ during each 3 month home trial with each device.
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~during each 3 month home trial with each device.
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in 10 Meter Walk Test speed
Secondary outcome measures
Activities Specific Balance Confidence Scale
Berg Balance Test
Borg Rate of Perceived Exertion
+13 moreOther outcome measures
Community Mobility
Cross Walk Blinking Signal Test
Self Reported Goals
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Group AExperimental Treatment1 Intervention
Group A receives the intervention Nomad KAFO first; fitting & training will occur with the intervention and will then be used for a 3 month home trial, followed by outcomes testing. Group A then will cross over and train with their own Traditional Assistive Device and will then use their own device for a 3 month home trial, followed by outcomes testing.
Group II: Group BActive Control1 Intervention
Group B receives training in their own Traditional Assistive Device first; training will occur with their own Traditional Assistive Device and will then use their own device for a 3 month home trial, followed by outcomes testing. Group B then will cross over and receive the intervention Nomad KAFO; fitting & training will occur with the intervention and will then be used for a 3 month home trial, followed by outcomes testing.
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Who is running the clinical trial?
Shirley Ryan AbilityLabLead Sponsor
194 Previous Clinical Trials
16,876 Total Patients Enrolled
1 Trials studying Paralysis
47 Patients Enrolled for Paralysis
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I cannot keep my body stable, even with support like crutches.I understand the study details and agree to participate.I regularly use a leg brace due to a neurological, muscle, or bone condition.I am willing to wear and charge an activity monitor for three months.My knee or hip cannot fully straighten, bending more than 15 degrees.My knee is bent inward/outward more than 15 degrees and can't be fixed.I experience severe muscle stiffness.
Research Study Groups:
This trial has the following groups:- Group 1: Group A
- Group 2: Group B
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 study include those aged 50 and above in its participants?
"This clinical trial only accepts individuals aged 18 to 89; those younger or older will have 193 and 1581 separate studies available, respectively."
Answered by AI
Who is eligible to participate in this research initiative?
"This clinical trial seeks 36 participants between 18 and 89 years old, with spinal cord injuries. To be considered eligible for this research, they must also fulfil the following conditions: possess a unilateral or bilateral KAFO/SCO brace (or related device), demonstrate cognitive capability to comply with the study protocol; sign an informed consent form, and wear & charge a monitored activity tracker during 3 months of home trials."
Answered by AI
Are there any open enrollment opportunities for this research study?
"Unfortunately, according to the clinicaltrials.gov records, this particular trial is not presently accepting applicants. This experiment was initially posted on March 1st 2023 and last updated on February 21st 2023; however, there are 1880 other trials currently seeking participants."
Answered by AI
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