Kessler Foundation
West Orange, New Jersey, 07052, United States
Location status: Recruiting
Location contact
Karen J Nolan
PRINCIPAL_INVESTIGATOR
Kate Chervin
CONTACT
Sharon Franco
CONTACT
NCT Number: NCT06923293
The purpose of this research study is to assess the ease, convenience, and efficacy of walking when using a motor powered ankle foot orthosis (AFO) brace, in adults who have had a lower limb injury.
Interested in participating?
Request Info18 year–80 year
All sexes
Interventional
Not applicable
West Orange, New Jersey, 07052, United States
Location status: Recruiting
Karen J Nolan
PRINCIPAL_INVESTIGATOR
Kate Chervin
CONTACT
Sharon Franco
CONTACT
The long-term goal of this project is to improve the outcomes of robot-assisted exercise interventions for patients with reconstructed lower limb following high-energy lower extremity traumas using novel machine learning methods to enable individualized ankle foot orthosis (AFO) designs and self-adaptive AFO assistance.
The main hypothesis predicts greater comfort and lower pain levels when using the new AFO as well as improvements in gait mechanics, which will outperform those induced by patients' daily-use AFOs. The main goal is this adaptive assistance will encourage the wearer's active engagement in RAGT thereby promoting patient self-efficacy/satisfaction and leading to improvements in ambulation after a 6-week rehabilitation program.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
While part of this study, participants will be fitted for the motorized orthosis and will complete walking tests with and without the AFO.
Time frame: Measured before and after 6 week intervention to assess change from baseline.
10 meter walk test to evaluate walking speed after lower limb injury and in response to the intervention. Walking evaluated without versus with the motorized orthosis.
Time frame: Measured before and after 6 week intervention to assess change from baseline.
Timed up and go (TUG) test to measure functional balance and walking ability after lower limb injury and in response to the intervention. Walking evaluated without versus with the motorized orthosis.
Time frame: Measured before and after 6 week intervention to assess change from baseline.
6 minute walking test to evaluate endurance after lower limb injury and in response to the intervention. Walking evaluated without versus with the motorized orthosis.
Contact information is provided by the study sponsor or research team.
Kessler Foundation
Other
Individualizing Powered Orthotic Intervention for Improved Gait Outcomes Using ML-enabled Methods
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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