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

Not Applicable

Completed

• Conditions: Walking Aided by a Leg Brace in Stroke Subjects
• Interventions: Device: ADR™ brace resistance; Device: Conventional brace resistance (using hard stops)

• 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.

Study Timeline

• Study Start: 2013-01
• Study First Submitted: 2014-04-23
• Study First Submitted QC: 2014-04-23
• Study First Posted: 2014-04-25
• Primary Completion: 2016-10
• Study Completion: 2020-01-30
• Results First Submitted: 2020-03-19
• Results First Submitted QC: 2020-04-21
• Results First Posted: 2020-05-01
• Status Verified: 2021-09
• Last Update Submitted: 2021-09-06
• Last Update Posted: 2021-10-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 5

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Experimental then Conventional brace resistance	ADR™ brace resistance	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.
Conventional then Experimental brace resistance	Conventional brace resistance (using hard stops)	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.
Conventional then Experimental brace resistance	ADR™ brace resistance	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.
Experimental then Conventional brace resistance	Conventional brace resistance (using hard stops)	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.

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