Gait Training in Post-Stroke Hemiparesis Hemiparesis

NCT ID: NCT04877249

Last Updated: 2025-04-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 69 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-07-09
• Study Completion Date: 2025-03-28

Brief Summary

The focus of this study is to optimize the delivery of a combined strength and aerobic training regimen to individuals with post stroke hemiparesis and reduce overuse and inefficiencies associated with the nonparetic leg during walking. This study proposes to use 1) split-belt treadmill and 2) single belt treadmill walking using split belt simulation software for enhancing symmetrical walking patterns for people with stroke.

Detailed Description

This study will include twenty stroke survivors and twenty healthy adults (total 40 participants) who are 20 years or older. Both groups (stroke vs healthy) will be screened and recruited from a UTMB Stroke Support Group and local community in Galveston or Harris County for one year (2021-22). Healthy individuals will also participate in gait training compared to stroke participants. The focus of this gait training is to optimize the delivery of a combined strength and aerobic training regimen to older adults with post stroke hemiparesis and reduce overuse and inefficiencies associated with the nonparetic leg during walking. Investigators propose to use a combination of neuromechanical and biobehavioral approaches to enhance bilateral symmetry of limb propulsion using specialized split-belt, force-plate instrumented treadmill that uses backward directed resistance forces. With neuromechanics investigators will measure joint torque output, EMG muscle activity patterns, and trailing limb angle, while a person is walking under normal treadmill belt conditions versus the split-belt conditions at different levels of resistance. Electromyography (EMG) detects electrical activity during muscle contraction while the single or the split-belt treadmill walking. The joint torque output and trailing limb angle can be obtained by using the Vicon Motion System (Vicon, Oxford, UK) in conjunction with the Bertec split-belt, force plates instrumented treadmill (Bertec Corp., Columbus, OH). In addition, in terms of biobehavioral metrics, investigators will measure the extent to which people maintain improved paretic limb propulsion contributions immediately after the split-belt environment is restored to a single belt condition (i.e. aftereffects), and the ability of individuals to consciously alter their walking pattern so as to reduce compensatory walking patterns when they are not engaged with the specialized treadmill setup.

Conditions

Stroke

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Gait training for stroke

Group Type: EXPERIMENTAL

Split-belt treadmill training

Intervention Type: BEHAVIORAL

1\. Split-belt gait training without or with any resistance, 2. Facilitating the knee extension during the terminal swing phase of gait cycle to identify the impact on the propulsive force generation of paretic leg

Gait training for healthy

Group Type: ACTIVE_COMPARATOR

Split-belt treadmill training

Intervention Type: BEHAVIORAL

1\. Split-belt gait training without or with any resistance, 2. Facilitating the knee extension during the terminal swing phase of gait cycle to identify the impact on the propulsive force generation of paretic leg

Interventions

Split-belt treadmill training

1\. Split-belt gait training without or with any resistance, 2. Facilitating the knee extension during the terminal swing phase of gait cycle to identify the impact on the propulsive force generation of paretic leg

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• Healthy individuals, ages 20 or older
• Healthy participants will be required to be medically stable
• Healthy participants are able to walk at least 10 meters independently at a comfortable speed without an assistive device
• The participants with a history stroke, ages 20 or older
• Unilateral first stroke of ischemic origin in the carotid artery distribution
• Unilateral first stroke of hemorrhagic origin in the carotid artery distribution
• Diagnosis of stroke at least 6 months prior to participation
• Free of major post-stroke complications (e.g., recurrent stroke, hip fracture, myocardial infarction)
• Living within the community
• The participants with a history stroke are able to ambulate 10 meters with or without assistive devices

Exclusion Criteria

• A history of any significant orthopedic problems
• A history of psychiatric or cognitive illness (e.g., bipolar affective disorder, psychosis, schizophrenia, attention deficits, cognitive deficits, or medication refractor depression)
• Neurological problems
• Stroke secondary to subarachnoid hemorrhage or posterior circulation stroke
• Not expected to live more than one year
• Comatose
• Unable to follow 3 step commands
• Amputation
• Poorly controlled diabetes (e.g., foot ulceration)
• Blind
• Progressive neurological diseases
• Comprehensive aphasia
• Medical instability
• Significant musculoskeletal problems
• Congestive cardiac failure
• Unstable angina
• Peripheral vascular disease
• Neuropsychiatric disorders (e.g., dementia, cognitive deficits, and severe depression)

• Minimum Eligible Age: 20 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

The University of Texas Medical Branch, Galveston

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Mansoo Ko, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

University of Texas

Locations

School of Health Profession, University of Texas Medical Branch

Galveston, Texas, United States

Countries

United States

References

Moradian N, Ko M, Hurt CP, Brown DA. Effects of backward-directed resistance on propulsive force generation during split-belt treadmill walking in non-impaired individuals. Front Hum Neurosci. 2023 Dec 4;17:1214967. doi: 10.3389/fnhum.2023.1214967. eCollection 2023.

Reference Type: DERIVED

PMID: 38111676 (View on PubMed)

Other Identifiers

20-0091

Identifier Type: -

Identifier Source: org_study_id