This trial is active, not recruiting.

Condition walking aided by a leg brace in stroke subjects
Treatments adr™-based brace resistance (adjustable dynamic response™), conventional brace resistance (using hard stops)
Sponsor Albert Einstein Healthcare Network
Start date January 2013
End date October 2016
Trial size 5 participants
Trial identifier NCT02122783, HN 4422


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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model crossover assignment
Masking single blind (subject)
Primary purpose basic science
(Active Comparator)
Default intervention
conventional brace resistance (using hard stops)
Conventional polypropylene custom molded ankle foot orthosis (MAFO) with Lawrence style double channel adjustable joints containing pins/springs
Condition using the novel elastomer to provide brace support
adr™-based brace resistance (adjustable dynamic response™)

Primary Outcomes

self-selected walking velocity
time frame: 8 weeks
step length symmetry
time frame: 8 weeks
step time symmetry
time frame: 8 weeks

Secondary Outcomes

joint kinematics
time frame: 8 weeks
joint kinetics
time frame: 8 weeks
activity (step count)
time frame: 8 weeks
subject opinions
time frame: 8 weeks

Eligibility Criteria

Male or female participants from 21 years up to 70 years old.

Inclusion Criteria: 1. Between the ages of 21 and 70 males and non-pregnant females 2. Diagnosis of stroke more than 1 year ago 3. Ambulatory at 0.5m/s or greater 4. Require unilateral AFOs to ambulate 5. Stable medical condition - no concomitant progressive diseases that could affect motor function 6. Ability to comply with directions and cooperate with research team Exclusion Criteria: 1. Subjects who are currently receiving physical therapy for gait problems 2. Anticipated surgical or pharmacologic intervention for tone/contractures during the study period 3. 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) 4. Recent cardiac or active pulmonary disease, liable blood pressure 5. Recent back surgery

Additional Information

Official title Comparison of the Functional Walking Outcomes of Two Settings of a Commercially Available Ankle Foot Orthosis in Adult Stroke Patients
Trial information was received from ClinicalTrials.gov and was last updated in June 2016.
Information provided to ClinicalTrials.gov by Albert Einstein Healthcare Network.