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

Sponsor
Northwestern University (Other)
Overall Status
Completed
CT.gov ID
NCT02516176
Collaborator
(none)
38
1
1
48.9
0.8

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: treadmill training
N/A

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
38 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
The Feasibility and Efficacy of Induced Lateral Step Treadmill Training to Improve Paretic Limb Stepping Post-Stroke
Study Start Date :
Feb 1, 2015
Actual Primary Completion Date :
Mar 1, 2019
Actual Study Completion Date :
Mar 1, 2019

Arms and Interventions

Arm Intervention/Treatment
Experimental: Treadmill Training

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

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

Outcome Measures

Primary Outcome Measures

  1. Dynamic Balance in the Four Square Step Test [change from baseline at 3 weeks - immediately following the training sessions]

    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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Northwestern University Chicago Illinois United States 60611

Sponsors and Collaborators

  • Northwestern University

Investigators

  • Principal Investigator: Lois D Hedman, DSc PT, Northwestern University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Lois Deming Hedman, Associate Professor of Physical Therapy, Northwestern University
ClinicalTrials.gov Identifier:
NCT02516176
Other Study ID Numbers:
  • STU000200161
First Posted:
Aug 5, 2015
Last Update Posted:
Mar 13, 2019
Last Verified:
Mar 1, 2019
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Keywords provided by Lois Deming Hedman, Associate Professor of Physical Therapy, Northwestern University
Additional relevant MeSH terms:

Study Results

No Results Posted as of Mar 13, 2019