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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Walking Aided by a Leg Brace in Stroke Subjects

Intervention / Treatment
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* Device: ADR™ brace resistance
* Device: Conventional brace resistance (using hard stops)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Conventional then Experimental brace resistance<br>Participants received the Default intervention for a period of a month, were evaluated in the lab and then the novel intervention was administered for use for the next month. There was a small period (few hours in the lab) where the subject was transitioned to the second intervention. | Device: ADR™ brace resistance<br> <br> Device: Conventional brace resistance (using hard stops)<br>* Conventional polypropylene custom molded ankle foot orthosis (MAFO) with Lawrence style double channel adjustable joints containing pins/springs<br>|
| Experimental: Experimental then Conventional brace resistance<br>Participants received the the novel elastomer to provide brace support intervention for a period of a month, were evaluated in the lab and then the conventional intervention was administered for use for the next month. There was a small period (few hours in the lab) where the subject was transitioned to the second intervention. | Device: ADR™ brace resistance<br> <br> Device: Conventional brace resistance (using hard stops)<br>* Conventional polypropylene custom molded ankle foot orthosis (MAFO) with Lawrence style double channel adjustable joints containing pins/springs<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Self-selected Walking Velocity | walking velocity will be assessed by an electronic temporospatial foot-fall measurement system (gaitmat) | 8 weeks | 
| Step Length Symmetry | step length symmetry will be assessed by an electronic temporospatial foot-fall measurement system (gaitmat). symmetry will result in a ratio of step length on more involved or affected side compared to the less involved or affected (i.e. the normal) side. as such, the measure will appear to have no units but actually will be a ratio of the same units (in this case, meters to meters). | 8 weeks | 
| Step Time Symmetry | step time symmetry will be assessed by an electronic temporospatial foot-fall measurement system (gaitmat). symmetry will result in a ratio of step time on more involved or affected side compared to the less involved or affected (i.e. the normal) side. as such, the measure will appear to have no units but actually will be a ratio of the same units (in this case, seconds to seconds). | 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Joint Kinematics | joint kinematics will be assessed using motion capture system | 8 weeks | 
| Joint Kinetics | joint kinematics will be assessed using motion capture and biomechanical force measurement systems | 8 weeks | 
| Activity (Step Count) | activity will be measured using accelerometer based step activity monitoring devices | 8 weeks | 
| Subject Opinions | subject opinions will be measured using surveys and questionnaires | 8 weeks |