An interventional study of Ankle Orthotic in Gait, Hemiplegic, sponsored by University of Delaware. Completed at 1 site in United States. Per ClinicalTrials.gov, last updated 2023-09-15.
Sponsored by University of Delaware · Not applicable, Interventional, and Basic science
When people walk, their ankle joints help to hold them upright and move them forward. Ankle braces are often given to people who have had a stroke to help their ankle joints work properly. The investigators have developed a method to design and make a special type of ankle brace that allows the investigators to control every characteristic of the ankle brace, allowing the investigators to customize the ankle brace to fit and function just the way the investigators want it to. The investigators think that ankle braces customized to meet the needs of each individual person will help the participants walk better. The investigators have also developed a prescription model that tells the investigators how to customize these ankle braces to address different levels of two common impairments experienced by people post stroke -decreased ability to move the ankle joint and weakened calf muscles. The purpose of this study is to test the prescription model to see if wearing the ankle brace customized based on the prescription model improves people's ability to walk. To accomplish this goal, the investigators will first measure each person's ability to move his/her ankle joint and the strength of his/her calf muscles. The investigators will put this information in to the prescription model to determine how to customize the ankle brace for each person. The investigators will then use the method developed to make the customized ankle brace. Finally, the investigators will measure how each person walks in the ankle brace customized just for the participants. This study will allow the investigators to validate and/or refine the prescription model and teach the investigators how persons post-stroke adapt to walking in ankle braces with different characteristics.
327 studies on the registry are indexed under Gait Disorders, Neurologic; 54 are open to participants now.
This study's enrollment of 32 is close to the median of 30 across 246 interventional studies indexed under Gait Disorders, Neurologic.
Browse Gait Disorders, Neurologic studies →University of Delaware is the lead sponsor of 125 studies on the registry; 23 are open to participants now.
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Exclusion Criteria:
The participant will wear two different ankle orthotics, their currently prescribed orthotic and the experimental orthotic.
Device: Ankle Orthotic
Peak Plantar Flexion Moment
The peak plantar flexion moment (Newton - meters per degree) will be measured at 0, 2, and 4 weeks via an instrumented gait analysis while the participant walks at their self-selected walking speed wearing their ankle brace.
Time frame: 4 weeks
Step Length
Step Length (meters) will be measured via an instrumented gait analysis 0, 2, and 4 weeks while the participant walks at their self-selected walking speed wearing their ankle brace.
Time frame: 4 weeks
Step Ratio
Step ratio (unitless) will be measured via an instrumented gait analysis 0, 2, and 4 weeks while the participant walks at their self-selected walking speed wearing their ankle brace.
Time frame: 4 weeks
Propulsion Impulse Ratio
Propulsion Impulse Ratio (unitless) will be measured via an instrumented gait analysis 0, 2, and 4 weeks while the participant walks at their self-selected walking speed wearing their ankle brace.
Time frame: 4 weeks
Ankle Power
Ankle Power (Work) will be measured via an instrumented gait analysis 0, 2, and 4 weeks while the participant walks at their self-selected walking speed wearing their ankle brace.
Time frame: 4 weeks
Propulsion Force
Propulsion Force (Newtons) will be measured via an instrumented gait analysis 0, 2, and 4 weeks while the participant walks at their self-selected walking speed wearing their ankle brace.
Time frame: 4 weeks
Plan to share: No
This study is completed, as verified in Sep 2023. You cannot join it, but the record below documents what was studied.
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University of Delaware