Retraining the Walking Pattern After Stroke

NCT03813342 | Completed

• 2 other identifiers: IRB000975732R37NS090610
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

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.

Conditions

Stroke; Hemiparesis

Keywords

stroke; gait training; visual feedback

Outcome Measures

Primary Outcomes (1)

• 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.

  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 Outcomes (2)

• 1. Change in walking speed

  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.

• 2. Change in subjective assessment of balance confidence

  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.

Study Arms (2)

Multichannel Visual Feedback

EXPERIMENTAL

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).

Behavioral: Gait training with visual feedback of joint kinematics

Single Channel Visual Feedback

EXPERIMENTAL

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).

Behavioral: Gait training with visual feedback of joint kinematics

Interventions

Gait training with visual feedback of joint kinematics 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.

Multichannel Visual Feedback; Single Channel Visual Feedback

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hugo W. Moser Research Institute at Kennedy Krieger, Inc.: lead
• National Institutes of Health (NIH): collaborator
• National Institute of Neurological Disorders and Stroke (NINDS): collaborator

Study Sites (1)

Motion Analysis Lab in the Kennedy Krieger Institute

Baltimore, Maryland, 21205, United States

Location

MeSH Terms

Conditions

Stroke; Paresis

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Amy J Bastian, PhD, PT

  Kennedy Krieger Institute and Johns Hopkins School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Neuroscience

Model Details: treadmill with multi-dimensional and one-dimensional feedback

Study Record Dates

• First Submitted: January 14, 2019
• First Posted: January 23, 2019
• Study Start: February 6, 2019
• Primary Completion: December 20, 2023
• Study Completion: December 21, 2023
• Last Updated: June 4, 2024

Record last verified: 2024-06

Locations

US (1)