Comparison of the Functional Walking Outcomes of Two Settings of a Commercially Available AFO in Adult Stroke Patients
- Conditions
- Walking Aided by a Leg Brace in Stroke Subjects
- Registration Number
- NCT02122783
- Lead Sponsor
- Albert Einstein Healthcare Network
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 5
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Primary Outcome Measures
Name Time Method Step Time Symmetry 8 weeks 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).
Self-selected Walking Velocity 8 weeks walking velocity will be assessed by an electronic temporospatial foot-fall measurement system (gaitmat)
Step Length Symmetry 8 weeks 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).
- Secondary Outcome Measures
Name Time Method Joint Kinematics 8 weeks joint kinematics will be assessed using motion capture system
Joint Kinetics 8 weeks joint kinematics will be assessed using motion capture and biomechanical force measurement systems
Subject Opinions 8 weeks subject opinions will be measured using surveys and questionnaires
Activity (Step Count) 8 weeks activity will be measured using accelerometer based step activity monitoring devices
Trial Locations
- Locations (1)
MossRehab
🇺🇸Elkins Park, Pennsylvania, United States
MossRehab🇺🇸Elkins Park, Pennsylvania, United States