N/A N=5 Randomized Single-blind Basic Science

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

Walking Aided by a Leg Brace in Stroke Subjects

Bottom Line

View on ClinicalTrials.gov: NCT02122783 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

May 2020

Primary outcome: Primary: Self-selected Walking Velocity — 0.71; 0.74 m/s

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: ADR™ brace resistance (Device); Conventional brace resistance (using hard stops) (Device)
Age: Adult, Older Adult · 21+ yrs
Sex: All
Sponsor: Albert Einstein Healthcare Network
Primary completion: Oct 2016

Outcome Measures

Outcome	Result	p-value
PRIMARY Self-selected Walking Velocity	0.71; 0.74	—
PRIMARY Step Length Symmetry	0.98; 0.96	—
PRIMARY Step Time Symmetry	1.03; 0.99	—
SECONDARY Joint Kinematics	—	—
SECONDARY Joint Kinetics	—	—
SECONDARY Activity (Step Count)	—	—
SECONDARY Subject Opinions	—	—

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.

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02122783). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.