Retraining the Walking Pattern After Stroke

NCT ID: NCT03813342

Last Updated: 2024-06-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 8 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-02-06
• Study Completion Date: 2023-12-21

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.

Conditions

Stroke; Hemiparesis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Multichannel Visual Feedback

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).

Group Type: EXPERIMENTAL

Gait training with visual feedback of joint kinematics

Intervention Type: BEHAVIORAL

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.

Single Channel Visual Feedback

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).

Group Type: EXPERIMENTAL

Gait training with visual feedback of joint kinematics

Intervention Type: BEHAVIORAL

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.

Interventions

Gait training with visual feedback of joint kinematics

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.

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institutes of Health (NIH)

NIH

Sponsor Role: collaborator

National Institute of Neurological Disorders and Stroke (NINDS)

NIH

Sponsor Role: collaborator

Hugo W. Moser Research Institute at Kennedy Krieger, Inc.

OTHER

Sponsor Role: lead

Responsible Party

Amy J. Bastian, Ph.D.

Professor of Neuroscience

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Amy J Bastian, PhD, PT

Role: PRINCIPAL_INVESTIGATOR

Kennedy Krieger Institute and Johns Hopkins School of Medicine

Locations

Motion Analysis Lab in the Kennedy Krieger Institute

Baltimore, Maryland, United States

Countries

United States

Other Identifiers

2R37NS090610

Identifier Type: NIH

Identifier Source: secondary_id

View Link

IRB00097573

Identifier Type: -

Identifier Source: org_study_id