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



Status:Active, not recruiting
Conditions:Neurology
Therapuetic Areas:Neurology
Healthy:No
Age Range:21 - 70
Updated:4/17/2018
Start Date:January 2013
End Date:October 2018

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

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.

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.

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
We found this trial at
1
site
Elkins Park, Pennsylvania 19027
Principal Investigator: Mukul Talaty, PhD
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mi
from
Elkins Park, PA
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