Gait Training in Post-Stroke Hemiparesis Hemiparesis

NCT04877249 | Completed

• 1 other identifier: 20-0091
• Study Type: interventional
• Target: 69
• Locations: 1 country
• Sites: 1

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.

Conditions

Stroke

Keywords

Hemiparesis; Split-belt treadmill; gait training

Outcome Measures

Primary Outcomes (8)

• Bilateral symmetry of ground reaction forces during split-belt treadmill walking

  Vertical, horizontal, and mediolateral ground reaction force changes will be measured in response to split/tied belt speed and with (or without) a resistance using the Bertec split-belt, force plates instrumented treadmill and the Vicon 3D motion analysis system.

  Single point of assessment in one day and ground reaction forces will be recorded continuously for 20-30minutes and will be expressed per gait cycle

• Bilateral symmetry of joint torques during split-belt treadmill walking

  Joint torques changes of ankle, knee, and hip joints will be measured in response to split/tied belt speed and with (or without) a resistance using the Bertec split-belt, force plates instrumented treadmill and the Vicon 3D motion analysis system.

  Single point of assessment in one day and joint torques will be recorded continuously for 20-30minutes and will be expressed per gait cycle

• Trailing limb angle during split-belt treadmill walking

  Peak trailing limb angle changes will be measured in response to split/tied belt speed and with (or without) a resistance using the Bertec split-belt, force plates instrumented treadmill and the Vicon 3D motion analysis system.

  Single point of assessment in one day and trailing limb angle will be recorded continuously for 20-30minutes and will be expressed per gait cycle

• Bilateral muscles activities during split-belt treadmill walking

  Timing (milliseconds) of Soleus, Tibialis Anterior, and Quadriceps muscle activities changes will be recorded continuously in response to split/tied belt speed and with (or without) a resistance using Delsys wireless EMG system.

  Single point of assessment in one day and muscle activity will be recorded continuously for 20-30minutes and will be expressed per gait cycle

• Bilateral muscles activities during split-belt treadmill walking

  Peak amplitude (millivolts) of Soleus, Tibialis Anterior, and Quadriceps muscle activities changes will be recorded continuously in response to split/tied belt speed and with (or without) a resistance using Delsys wireless EMG system.

  Single point of assessment in one day and muscle activity will be recorded continuously for 20-30minutes and will be expressed per gait cycle

• Spatiotemporal patterns during split-belt treadmill walking

  Cadence (Step numbers/minute) during split/tied treadmill walking will be recorded continuously using the Vicon 3D motion analysis system.

  Single point of assessment in one day and spatiotemporal gait parameters will be recorded continuously for 20-30minutes and will be expressed per gait cycle.

• Spatiotemporal patterns during split-belt treadmill walking

  Step and stride length (cm) during split/tied treadmill walking will be recorded continuously using the Vicon 3D motion analysis system.

  Single point of assessment in one day and spatiotemporal gait parameters will be recorded continuously for 20-30minutes and will be expressed per gait cycle.

• Spatiotemporal patterns during split-belt treadmill walking

  Stance and swing time (sec) during split/tied treadmill walking will be recorded continuously using the Vicon 3D motion analysis system.

  Single point of assessment in one day and spatiotemporal gait parameters will be recorded continuously for 20-30minutes and will be expressed per gait cycle.

Secondary Outcomes (6)

• Spatiotemporal patterns of overground walking

  Baseline assessment before split/tied treadmill walking

• Spatiotemporal patterns of overground walking

  Baseline assessment before split/tied treadmill walking

• Spatiotemporal patterns of overground walking

  Baseline assessment before split/tied treadmill walking

• Spatiotemporal patterns of overground walking

  Baseline assessment before split/tied treadmill walking

• Kinematic representation of the temporal events during standing and walking

  Baseline assessment before split/tied treadmill walking

Study Arms (2)

Gait training for stroke

EXPERIMENTAL

Behavioral: Split-belt treadmill training

Gait training for healthy

ACTIVE COMPARATOR

Behavioral: Split-belt treadmill training

Interventions

Split-belt treadmill training 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; Gait training for stroke

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• The University of Texas Medical Branch, Galveston: lead

Study Sites (1)

School of Health Profession, University of Texas Medical Branch

Galveston, Texas, 77550, United States

Location

Related Publications (1)

• 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.

  PMID: 38111676 DERIVED

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

• Mansoo Ko, Ph.D.

  University of Texas

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 7, 2021
• First Posted: May 7, 2021
• Study Start: July 9, 2021
• Primary Completion: June 5, 2024
• Study Completion: March 28, 2025
• Last Updated: April 11, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)