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

Completed · Not applicable

Conditions studied: Walking Aided by a Leg Brace in Stroke Subjects

In brief

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.

Key facts

Study ID

NCT02122783

Run by

Albert Einstein Healthcare Network

People needed

5

Starts

2013-01-01

Expected to finish

2020-01-30

Last updated by the study team

2021-10-04

Who can join

Age: 21 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Between the ages of 21 and 70 males and non-pregnant females
• Diagnosis of stroke more than 1 year ago
• Ambulatory at 0.5m/s or greater
• Require unilateral AFOs to ambulate
• Stable medical condition - no concomitant progressive diseases that could affect motor function
• Ability to comply with directions and cooperate with research team

You may not qualify if…

• Subjects who are currently receiving physical therapy for gait problems
• Anticipated surgical or pharmacologic intervention for tone/contractures during the study period
• Additional neurologic or musculoskeletal diagnoses that might impair gait (i.e., recent orthopedic interventions (6 weeks), unhealed fractures, significant degenerative joint disease, lower limb amputation, uncontrolled seizures)
• Recent cardiac or active pulmonary disease, liable blood pressure
• Recent back surgery

Where it is running

• MossRehab — Elkins Park, Pennsylvania, United States

Full record on ClinicalTrials.gov

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