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Retraining the Walking Pattern After Stroke

Primary Purpose

Stroke, Hemiparesis

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Gait training with visual feedback of joint kinematics
Sponsored by
Hugo W. Moser Research Institute at Kennedy Krieger, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke focused on measuring stroke, gait training, visual feedback

Eligibility Criteria

20 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • stroke or hemiparesis (>6 months post stroke)
  • able to walk but has a residual gait deficit (including those who walk with a cane or walker)
  • Able to walk for 5 minutes at their self-paced speed
  • Adults age 20-80

Exclusion Criteria:

  • Cerebellar signs (e.g.ataxic hemiparesis)
  • Any neurologic condition other than stroke
  • Uncontrolled diabetes
  • Congestive heart failure
  • Peripheral artery disease with claudication
  • Pulmonary or renal failure
  • Unstable angina
  • Uncontrolled hypertension (>190/110 mmHg)
  • MoCA (Montreal Cognitive Assessment Test for Dementia) < 23
  • Severe aphasia
  • Orthopedic or pain conditions that limit walking
  • Pregnancy

Sites / Locations

  • Motion Analysis Lab in the Kennedy Krieger InstituteRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Multichannel Visual Feedback

Single Channel Visual Feedback

Arm Description

Gait training with visual feedback of joint kinematics. The visual feedback will contain information about the lower limb joint angles. We will instruct subjects to use the feedback to reach a target walking pattern. In this arm, subjects will receive 4 channels of visual information, each of which represents a joint angle (right and left hips, right and left knees).

Gait training with visual feedback of joint kinematics. The visual feedback will contain information about the lower limb joint angles. We will instruct subjects to use the feedback to reach a target walking pattern. In this arm, subjects will receive 1 channel of visual information that encompasses information from 4 lower limb joint angles (right and left hips, right and left knees).

Outcomes

Primary Outcome Measures

1. Change in hip and knee joint movements while walking
How closely the hip and knee movements in participants post-stroke match those of a healthy gait patter. To collect this measure, subjects will wear special markers on their feet and body to record how their legs are moving while they walk on the treadmill.

Secondary Outcome Measures

1. Change in walking speed
Subjects will complete clinical tests of walking speed by walking overground at two paces - their normal comfortable pace and as fast as safely possible.
2. Change in subjective assessment of balance confidence
Subjects will complete the 16-item Activities-Specific Balance Confidence Scale. This is a self-report measure in which they rate their confidence that they would not lose their balance while performing specific daily activities. Scores can range from 0 - 100, with 0 indicating the respondent has no confidence in their balance and 100 indicating that they are full confident that they can perform all items without a loss of balance. As such, higher values represent a better outcome. There are no sub-scales for this measure.

Full Information

First Posted
January 14, 2019
Last Updated
March 28, 2023
Sponsor
Hugo W. Moser Research Institute at Kennedy Krieger, Inc.
Collaborators
National Institutes of Health (NIH), National Institute of Neurological Disorders and Stroke (NINDS)
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1. Study Identification

Unique Protocol Identification Number
NCT03813342
Brief Title
Retraining the Walking Pattern After Stroke
Official Title
Retraining the Walking Pattern After Stroke
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 6, 2019 (Actual)
Primary Completion Date
January 14, 2024 (Anticipated)
Study Completion Date
April 14, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hugo W. Moser Research Institute at Kennedy Krieger, Inc.
Collaborators
National Institutes of Health (NIH), National Institute of Neurological Disorders and Stroke (NINDS)

4. Oversight

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

5. Study Description

Brief Summary
The purpose of the study is to determine the effects of pairing gait training with different forms of visual feedback about leg movements in individual post-stroke to modify/normalize their gait pattern over time.
Detailed Description
Stroke often results in functional gait deficits and abnormal gait patterns. Typically, several features of gait are altered (e.g. knee joint movement decreases and step lengths are asymmetric). Data show that walking patterns after neurologic injury can be changed through gait training, but traditional rehabilitation approaches typically focus on changing one feature of gait at a time. However, the investigators have recently shown that in a single session individuals post-stroke are able to learn to change multiple components of this impaired gait pattern at the same time. To further leverage this ability to learn multiple things at once, the investigators have also studied how different forms of visual feedback about leg movements may best facilitate individuals to make meaningful changes to multiple features of the gait pattern. Specifically, they have studied two forms of visual feedback - 1) multidimensional, with multiple streams of information about leg movements, and 2) one-dimensional, which distills/summarizes multiple pieces of information about the gait pattern into a single source of feedback. They have shown that the one-dimensional summary feedback is more effective to help people learn a new gait pattern that requires changing multiple features of how they are walking. This work has focused on single training sessions in neurologically intact individuals, but the authors would like to study the effects of longer-term training with these different forms of feedback. Therefore, the purpose of this study is to gather preliminary data to inform the design of a clinical trial of gait training to treat walking deficits post-stroke. The investigators will gather data to determine whether training with different forms of visual feedback about leg movements are effective at improving gait patterns post-stroke - and which form of feedback may be more effective. The investigators will study adults with cerebral damage due to stroke. Subjects with hemiparesis will undergo training 3 times a week for a total of 12 training session. These 12 sessions will be broken into 2 blocks of 6 sessions, with at least a 2 week break in between. In each block, training will occur with one form of visual (multi- or one-dimensional). Participants will complete training with both forms of feedback, the order of feedback forms will be randomly assigned. These studies will provide important new information about gait training with visual feedback in individuals post-stroke. This study is critical for developing procedural reliability processes, calculating effect sizes, and determining other salient clinical variables in preparation for a randomized clinical trial.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke, Hemiparesis
Keywords
stroke, gait training, visual feedback

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
treadmill with multi-dimensional and one-dimensional feedback
Masking
None (Open Label)
Allocation
Randomized
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Multichannel Visual Feedback
Arm Type
Experimental
Arm Description
Gait training with visual feedback of joint kinematics. The visual feedback will contain information about the lower limb joint angles. We will instruct subjects to use the feedback to reach a target walking pattern. In this arm, subjects will receive 4 channels of visual information, each of which represents a joint angle (right and left hips, right and left knees).
Arm Title
Single Channel Visual Feedback
Arm Type
Experimental
Arm Description
Gait training with visual feedback of joint kinematics. The visual feedback will contain information about the lower limb joint angles. We will instruct subjects to use the feedback to reach a target walking pattern. In this arm, subjects will receive 1 channel of visual information that encompasses information from 4 lower limb joint angles (right and left hips, right and left knees).
Intervention Type
Behavioral
Intervention Name(s)
Gait training with visual feedback of joint kinematics
Intervention Description
Gait training will be accomplished using a Woodway treadmill. The visual feedback will contain information about the real-time lower-limb joint angles. We will instruct participants to use the feedback to reach a target walking pattern.
Primary Outcome Measure Information:
Title
1. Change in hip and knee joint movements while walking
Description
How closely the hip and knee movements in participants post-stroke match those of a healthy gait patter. To collect this measure, subjects will wear special markers on their feet and body to record how their legs are moving while they walk on the treadmill.
Time Frame
Assessed before and after the gait training provided in each Arm of the study to assess a change following each intervention. This measure will be collected during the first and last sessions of Arms 1 and 2, occurring within two weeks for each Arm.
Secondary Outcome Measure Information:
Title
1. Change in walking speed
Description
Subjects will complete clinical tests of walking speed by walking overground at two paces - their normal comfortable pace and as fast as safely possible.
Time Frame
Assessed before and after the gait training provided in each Arm of the study to assess a change following each intervention. This measure will be collected during the first and last sessions of Arms 1 and 2, occurring within two weeks for each Arm.
Title
2. Change in subjective assessment of balance confidence
Description
Subjects will complete the 16-item Activities-Specific Balance Confidence Scale. This is a self-report measure in which they rate their confidence that they would not lose their balance while performing specific daily activities. Scores can range from 0 - 100, with 0 indicating the respondent has no confidence in their balance and 100 indicating that they are full confident that they can perform all items without a loss of balance. As such, higher values represent a better outcome. There are no sub-scales for this measure.
Time Frame
Assessed before and after the gait training provided in each Arm of the study to assess a change following each intervention. This measure will be collected during the first and last sessions of Arms 1 and 2, occurring within two weeks for each Arm.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: stroke or hemiparesis (>6 months post stroke) able to walk but has a residual gait deficit (including those who walk with a cane or walker) Able to walk for 5 minutes at their self-paced speed Adults age 20-80 Exclusion Criteria: Cerebellar signs (e.g.ataxic hemiparesis) Any neurologic condition other than stroke Uncontrolled diabetes Congestive heart failure Peripheral artery disease with claudication Pulmonary or renal failure Unstable angina Uncontrolled hypertension (>190/110 mmHg) MoCA (Montreal Cognitive Assessment Test for Dementia) < 23 Severe aphasia Orthopedic or pain conditions that limit walking Pregnancy
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Anthony Gonzalez, BS
Phone
4439232716
Email
gonzalezan@kennedykrieger.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Amy J Bastian, PhD, PT
Organizational Affiliation
Kennedy Krieger Institute and Johns Hopkins School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Motion Analysis Lab in the Kennedy Krieger Institute
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21205
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Anthony J Gonzalez, BS
Phone
443-923-2716
Email
gonzalezan@kennedykrieger.org
First Name & Middle Initial & Last Name & Degree
Amy J Bastian, PhD, PT

12. IPD Sharing Statement

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Retraining the Walking Pattern After Stroke

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