Identifying the Optimal Dynamic Ankle-Foot Orthosis Bending Stiffness for Individuals Post-Stroke

Launched by UNIVERSITY OF DELAWARE · Mar 4, 2024

Keywords

ClinConnect Summary

This clinical trial is studying how to make ankle braces, called AFOs (ankle-foot orthoses), work better for people who have had a stroke. These braces help support the ankle and improve walking, but there isn't a standard way to choose the right one for each person. The researchers want to find out how different levels of support from these braces can help improve walking ability. Participants will try on a brace with five different levels of assistance while their walking performance and experiences are monitored.

To be eligible for this study, participants should be at least six months post-stroke, have been prescribed an AFO, and have some weakness in their ankle muscles. However, certain individuals, such as those with additional neurological conditions or severe mobility issues, won’t be included. If you participate, you can expect to walk with various brace settings and share your feedback, which will help create guidelines for clinicians to better match braces to patients' needs in the future. This trial is an important step toward ensuring that stroke survivors receive the best possible support for their recovery.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • chronic stroke (\> 6 months post-stroke)
• • been prescribed an AFO by a clinician
• • have plantar flexor strength deficits (unable to complete at least 25 standing heel-raises
• • have at least 5 degrees of passive dorsiflexion range of motion (as measured during the clinical evaluation in Visit 1).
• Exclusion Criteria:
• • Those that will not be included in this study are individuals with 1) Evidence of cerebellar stroke on clinical MRI, 2) Other neurologic conditions in addition to stroke, 3) Sensorimotor neglect, 4) Inability to walk outside the home prior to the stroke, 5) Total joint replacement or orthopedic problems in the lower limbs or spine that limit walking, 6) Coronary artery bypass graft or myocardial infarction within past 3 months, 7) Unexplained dizziness in last 6 months, 8) Inability to communicate with investigators, 9) Lack of decisional capacity.