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Sideways Treadmill Training to Improve Paretic Leg Stepping in Persons Post-Stroke

Primary Purpose

Stroke, Hemiparesis

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
treadmill training
Sponsored by
Northwestern University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke focused on measuring stroke, cerebral vascular accident, balance, treadmill, falls, hemiparesis

Eligibility Criteria

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

Inclusion Criteria for subjects who have had a stroke:

  • at least 18 years old
  • a stroke survivor for at least 3 months
  • able to understand the testing instructions
  • able to walk 10 steps independently without an assistive device
  • living in the community (at home in an apartment, condo or house).
  • may have a history of one or more strokes but must present with one-sided hemiparesis

Exclusion Criteria for subjects who have had a stroke:

  • currently participating in physical therapy for balance and gait-training
  • other major musculoskeletal or other neurological disorders
  • residing in skilled nursing or assisted living facilities.

Exclusion criteria for subjects who have not had a stroke:

  • other major musculoskeletal or neurological disorders

Sites / Locations

  • Northwestern University

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Treadmill Training

Arm Description

Paretic leg step training while standing on a treadmill sideways and responding to treadmill being turned on suddenly.

Outcomes

Primary Outcome Measures

Dynamic Balance in the Four Square Step Test
The FSST is a timed test that assesses a person's ability to step forwards, sideways, and backwards over canes that are placed on the floor

Secondary Outcome Measures

Full Information

First Posted
July 22, 2015
Last Updated
March 11, 2019
Sponsor
Northwestern University
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1. Study Identification

Unique Protocol Identification Number
NCT02516176
Brief Title
Sideways Treadmill Training to Improve Paretic Leg Stepping in Persons Post-Stroke
Official Title
The Feasibility and Efficacy of Induced Lateral Step Treadmill Training to Improve Paretic Limb Stepping Post-Stroke
Study Type
Interventional

2. Study Status

Record Verification Date
March 2019
Overall Recruitment Status
Completed
Study Start Date
February 2015 (undefined)
Primary Completion Date
March 2019 (Actual)
Study Completion Date
March 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Northwestern University

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
People who are living in the community following a stroke fall frequently. The ability to take a step in response to a balance disturbance helps to prevent falls but stroke survivors tend not to step with their paretic leg in these circumstances. This leaves them vulnerable to falls towards their paretic side. The purpose of this study is to train paretic limb stepping by having individuals stand sideways on a treadmill and respond to sudden accelerations of the treadmill.
Detailed Description
Stroke survivors living in the community are at high risk for falling. Falls are considered to be one of the most prevalent post-stroke complications. Fall history in this population has been associated with developing activity limitation, decreased independence and increased fear of falling. The ability to step in response to an equilibrium disturbance is considered to be critical to prevent a fall. Stroke survivors tend not to step with their paretic limb when their standing equilibrium is perturbed. Training the paretic limb to step in response to perturbations has had limited success in stroke survivors. In response to sagittal plane perturbation training, stroke survivors continued tend to step with their non-paretic leg even when cued or induced to step with paretic leg. This tendency decreases their flexibility to respond to perturbations and also makes it difficult to train the paretic limb. In contrast, coronal plane perturbations may be a useful way to induce paretic limb stepping. Acceleration and deceleration of a treadmill has been used to train reactive stepping in all directions persons with Parkinson's Disease. Coronal plane perturbations may elicit greater responses from the paretic limb but this has never been investigated in the stroke population. In this study participants will engage in 6 training sessions over 2-3 weeks. They will stand sideways on the treadmill with their paretic leg towards the front of the treadmill belt, which will be suddenly accelerated for 3 seconds to a predetermined velocity. Participants will perform 80 trials each session under one or more of the following four training conditions. NON-ENCOURAGED TREADMILL ONLY: These trials are defined as trials when the subject is instructed to respond as necessary to remain on the front half of the treadmill while maintaining their balance without using external supports, but are not given any specific instructions about which limb to use to initiate stepping when the treadmill begins to move. NON-ENCOURAGED USE TREADMILL PLUS SECONDARY TASK: All the same procedures for non-encouraged use treadmill only trials will be used with the following addition. Just after the subject attains equal weight bearing, the subject will be engaged in a cognitive task to name as many items in a category as they are able. During this time period, the treadmill will be started randomly. ENCOURAGED USE TREADMILL ONLY TRIALS: These trials are defined as trials where subjects will be instructed to respond as necessary to remain on the front half of the treadmill while maintaining their balance without using external supports AND to initiate stepping with his or her paretic leg when the treadmill begins to move. ENCOURAGED USE TREADMILL PLUS SECONDARY TASK: All the same procedures for encouraged use treadmill only trials will be used with the following addition. Just after the subject attains equal weight bearing, the subject will be engaged in a cognitive task to name as many items in a category as they are able. During this time period, the treadmill will be started at randomly. In pilot testing, this protocol has been tolerated by most community dwelling stroke survivors and the encouraged use trials with feedback consistently elicited paretic leg reactive steps.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke, Hemiparesis
Keywords
stroke, cerebral vascular accident, balance, treadmill, falls, hemiparesis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
38 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Treadmill Training
Arm Type
Experimental
Arm Description
Paretic leg step training while standing on a treadmill sideways and responding to treadmill being turned on suddenly.
Intervention Type
Behavioral
Intervention Name(s)
treadmill training
Intervention Description
Paretic leg step training while standing on a treadmill sideways and responding to treadmill being turned on suddenly.
Primary Outcome Measure Information:
Title
Dynamic Balance in the Four Square Step Test
Description
The FSST is a timed test that assesses a person's ability to step forwards, sideways, and backwards over canes that are placed on the floor
Time Frame
change from baseline at 3 weeks - immediately following the training sessions

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria for subjects who have had a stroke: at least 18 years old a stroke survivor for at least 3 months able to understand the testing instructions able to walk 10 steps independently without an assistive device living in the community (at home in an apartment, condo or house). may have a history of one or more strokes but must present with one-sided hemiparesis Exclusion Criteria for subjects who have had a stroke: currently participating in physical therapy for balance and gait-training other major musculoskeletal or other neurological disorders residing in skilled nursing or assisted living facilities. Exclusion criteria for subjects who have not had a stroke: other major musculoskeletal or neurological disorders
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lois D Hedman, DSc PT
Organizational Affiliation
Northwestern University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Northwestern University
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Sideways Treadmill Training to Improve Paretic Leg Stepping in Persons Post-Stroke

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