NCT02122783

Comparison of the Functional Walking Outcomes of Two Settings of a Commercially Available AFO in Adult Stroke Patients

Comparison of the Functional Walking Outcomes of Two Settings of a Commercially Available Ankle Foot Orthosis in Adult Stroke Patients

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 5 (actual)
• Sponsor: Albert Einstein Healthcare Network · Academic / Other
• Sex: All
• Age: 21 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate how two different settings of a commercially available ankle foot brace affect how stroke patients walk. The study brace is an ankle foot orthosis (AFO) that makes use of a newer type of joint that contains a soft insert, in addition to the conventional hard stops, to limit the range of motion of the ankle during walking. The results of this study will help to clarify 1) whether and how this new joint affects the way you walk, 2) whether it makes it easier for the clinician to align your brace and 3) your opinions about the new joint.

Detailed description

The purpose of this study is to evaluate how two different settings of a commercially available ankle foot brace affect how stroke patients walk. The study brace is an ankle foot orthosis (AFO) that makes use of a newer type of joint that contains a soft insert, in addition to the conventional hard stops, to limit the range of motion of the ankle during walking. Participants undergo testing in the gaitlab after using the new brace for a period of time. The results of this study will help to clarify 1) whether and how this new joint affects the way you walk, 2) whether it makes it easier for the clinician to align your brace and 3) your opinions about the new joint.

Conditions

• Walking Aided by a Leg Brace in Stroke Subjects

Interventions

Type	Name	Description
DEVICE	ADR™ brace resistance
DEVICE	Conventional brace resistance (using hard stops)	Conventional polypropylene custom molded ankle foot orthosis (MAFO) with Lawrence style double channel adjustable joints containing pins/springs

Timeline

• Start date: 2013-01-01
• Primary completion: 2016-10-01
• Completion: 2020-01-30
• First posted: 2014-04-25
• Last updated: 2021-10-04
• Results posted: 2020-05-01

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study