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

Primary Purpose

Walking Aided by a Leg Brace in Stroke Subjects

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
ADR™ brace resistance
Conventional brace resistance (using hard stops)
Sponsored by
Albert Einstein Healthcare Network
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Walking Aided by a Leg Brace in Stroke Subjects

Eligibility Criteria

21 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • MossRehab

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Conventional then Experimental brace resistance

Experimental then Conventional brace resistance

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Self-selected Walking Velocity
walking velocity will be assessed by an electronic temporospatial foot-fall measurement system (gaitmat)
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).
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).

Secondary Outcome Measures

Joint Kinematics
joint kinematics will be assessed using motion capture system
Joint Kinetics
joint kinematics will be assessed using motion capture and biomechanical force measurement systems
Activity (Step Count)
activity will be measured using accelerometer based step activity monitoring devices
Subject Opinions
subject opinions will be measured using surveys and questionnaires

Full Information

First Posted
April 23, 2014
Last Updated
September 6, 2021
Sponsor
Albert Einstein Healthcare Network
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1. Study Identification

Unique Protocol Identification Number
NCT02122783
Brief Title
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

2. Study Status

Record Verification Date
September 2021
Overall Recruitment Status
Completed
Study Start Date
January 2013 (undefined)
Primary Completion Date
October 2016 (Actual)
Study Completion Date
January 30, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Albert Einstein Healthcare Network

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Walking Aided by a Leg Brace in Stroke Subjects

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Participant
Allocation
Randomized
Enrollment
5 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Conventional then Experimental brace resistance
Arm Type
Experimental
Arm Description
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.
Arm Title
Experimental then Conventional brace resistance
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
ADR™ brace resistance
Intervention Type
Device
Intervention Name(s)
Conventional brace resistance (using hard stops)
Intervention Description
Conventional polypropylene custom molded ankle foot orthosis (MAFO) with Lawrence style double channel adjustable joints containing pins/springs
Primary Outcome Measure Information:
Title
Self-selected Walking Velocity
Description
walking velocity will be assessed by an electronic temporospatial foot-fall measurement system (gaitmat)
Time Frame
8 weeks
Title
Step Length Symmetry
Description
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).
Time Frame
8 weeks
Title
Step Time Symmetry
Description
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).
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
Joint Kinematics
Description
joint kinematics will be assessed using motion capture system
Time Frame
8 weeks
Title
Joint Kinetics
Description
joint kinematics will be assessed using motion capture and biomechanical force measurement systems
Time Frame
8 weeks
Title
Activity (Step Count)
Description
activity will be measured using accelerometer based step activity monitoring devices
Time Frame
8 weeks
Title
Subject Opinions
Description
subject opinions will be measured using surveys and questionnaires
Time Frame
8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mukul Talaty, PhD
Organizational Affiliation
Albert Einstein (MossRehab)
Official's Role
Principal Investigator
Facility Information:
Facility Name
MossRehab
City
Elkins Park
State/Province
Pennsylvania
ZIP/Postal Code
19027
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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