Clinical trial NCT02122783: Comparison of the Functional Walking Outcomes of Two Settings of a Commercially Available AFO in Adult Stroke Patients
Official title: Comparison of the Functional Walking Outcomes of Two Settings of a Commercially Available Ankle Foot Orthosis in Adult Stroke Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Walking Aided by a Leg Brace in Stroke Subjects
Lead sponsor: Albert Einstein Healthcare Network
Sponsor class: OTHER
First posted: 2014-04-25
Enrollment: 5
Sex: ALL
Minimum age (years): 21
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief 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.

Eligibility criteria: 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

Primary outcomes:
measure: Self-selected Walking Velocity
timeFrame: 8 weeks
measure: Step Length Symmetry
timeFrame: 8 weeks
measure: Step Time Symmetry
timeFrame: 8 weeks
Secondary outcomes:
measure: Joint Kinematics
timeFrame: 8 weeks
measure: Joint Kinetics
timeFrame: 8 weeks
measure: Activity (Step Count)
timeFrame: 8 weeks
measure: Subject Opinions
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Elkins Park
country: United States
facility: MossRehab
state: Pennsylvania
Study officials:
affiliation: Albert Einstein (MossRehab)
name: Mukul Talaty, PhD
role: PRINCIPAL_INVESTIGATOR
References: