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Gait Training in Post-Stroke Hemiparesis Hemiparesis

Primary Purpose

Stroke

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Split-belt treadmill training
Sponsored by
Mansoo Ko
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke focused on measuring Hemiparesis, Split-belt treadmill, gait training

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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)

Sites / Locations

  • School of Health Profession, University of Texas Medical BranchRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Gait training for stroke

Gait training for healthy

Arm Description

Outcomes

Primary Outcome Measures

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.
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.
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.
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.
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.
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.
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.
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.

Secondary Outcome Measures

Spatiotemporal patterns of overground walking
Walking speed (m/sec) during overground walking will be recorded continuously using the Zeno Walkway system.
Spatiotemporal patterns of overground walking
Cadence (Step numbers/minute) during overground walking will be recorded continuously using the Zeno Walkway system.
Spatiotemporal patterns of overground walking
Step and stride length (cm) during overground walking will be recorded continuously using the Zeno Walkway system.
Spatiotemporal patterns of overground walking
Stance and swing time (sec) during overground walking will be recorded continuously using the Zeno Walkway system.
Kinematic representation of the temporal events during standing and walking
The temporal events of foot position (sec) will be identified from ground reaction forces (GRFs) during standing and walking trials using the Tekscan High Resolution Mat.
Kinematic representation of the temporal events during standing and walking
The standing balance (cm2) will be measured using sway analysis from Tekscan High Resolution Mat.

Full Information

First Posted
April 7, 2021
Last Updated
January 20, 2023
Sponsor
Mansoo Ko
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1. Study Identification

Unique Protocol Identification Number
NCT04877249
Brief Title
Gait Training in Post-Stroke Hemiparesis Hemiparesis
Official Title
Gait Training to Reduce Compensatory Walking Patterns in Post-Stroke Hemiparesis
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 9, 2021 (Actual)
Primary Completion Date
December 16, 2023 (Anticipated)
Study Completion Date
December 16, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Mansoo Ko

4. Oversight

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

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke
Keywords
Hemiparesis, Split-belt treadmill, gait training

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Non-Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Gait training for stroke
Arm Type
Experimental
Arm Title
Gait training for healthy
Arm Type
Active Comparator
Intervention Type
Behavioral
Intervention Name(s)
Split-belt treadmill training
Intervention Description
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
Primary Outcome Measure Information:
Title
Bilateral symmetry of ground reaction forces during split-belt treadmill walking
Description
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.
Time Frame
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
Title
Bilateral symmetry of joint torques during split-belt treadmill walking
Description
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.
Time Frame
Single point of assessment in one day and joint torques will be recorded continuously for 20-30minutes and will be expressed per gait cycle
Title
Trailing limb angle during split-belt treadmill walking
Description
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.
Time Frame
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
Title
Bilateral muscles activities during split-belt treadmill walking
Description
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.
Time Frame
Single point of assessment in one day and muscle activity will be recorded continuously for 20-30minutes and will be expressed per gait cycle
Title
Bilateral muscles activities during split-belt treadmill walking
Description
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.
Time Frame
Single point of assessment in one day and muscle activity will be recorded continuously for 20-30minutes and will be expressed per gait cycle
Title
Spatiotemporal patterns during split-belt treadmill walking
Description
Cadence (Step numbers/minute) during split/tied treadmill walking will be recorded continuously using the Vicon 3D motion analysis system.
Time Frame
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.
Title
Spatiotemporal patterns during split-belt treadmill walking
Description
Step and stride length (cm) during split/tied treadmill walking will be recorded continuously using the Vicon 3D motion analysis system.
Time Frame
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.
Title
Spatiotemporal patterns during split-belt treadmill walking
Description
Stance and swing time (sec) during split/tied treadmill walking will be recorded continuously using the Vicon 3D motion analysis system.
Time Frame
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 Outcome Measure Information:
Title
Spatiotemporal patterns of overground walking
Description
Walking speed (m/sec) during overground walking will be recorded continuously using the Zeno Walkway system.
Time Frame
Baseline assessment before split/tied treadmill walking
Title
Spatiotemporal patterns of overground walking
Description
Cadence (Step numbers/minute) during overground walking will be recorded continuously using the Zeno Walkway system.
Time Frame
Baseline assessment before split/tied treadmill walking
Title
Spatiotemporal patterns of overground walking
Description
Step and stride length (cm) during overground walking will be recorded continuously using the Zeno Walkway system.
Time Frame
Baseline assessment before split/tied treadmill walking
Title
Spatiotemporal patterns of overground walking
Description
Stance and swing time (sec) during overground walking will be recorded continuously using the Zeno Walkway system.
Time Frame
Baseline assessment before split/tied treadmill walking
Title
Kinematic representation of the temporal events during standing and walking
Description
The temporal events of foot position (sec) will be identified from ground reaction forces (GRFs) during standing and walking trials using the Tekscan High Resolution Mat.
Time Frame
Baseline assessment before split/tied treadmill walking
Title
Kinematic representation of the temporal events during standing and walking
Description
The standing balance (cm2) will be measured using sway analysis from Tekscan High Resolution Mat.
Time Frame
Baseline assessment before split/tied treadmill walking

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mansoo Ko, Ph.D.
Phone
4097729555
Email
mako@utmb.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Robyn A Williams
Phone
409-772-3070
Email
rwilliam@UTMB.EDU
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mansoo Ko, Ph.D.
Organizational Affiliation
University of Texas
Official's Role
Principal Investigator
Facility Information:
Facility Name
School of Health Profession, University of Texas Medical Branch
City
Galveston
State/Province
Texas
ZIP/Postal Code
77550
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mansoo Ko, Ph.D
Phone
409-772-9555
Email
mako@utmb.edu
First Name & Middle Initial & Last Name & Degree
Robyn A William, BS
Phone
4097723070
Email
rwilliam@utmb.edu

12. IPD Sharing Statement

Plan to Share IPD
No

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Gait Training in Post-Stroke Hemiparesis Hemiparesis

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