NCT02190734

Brief Summary

Some individuals demonstrate pushing behaviors after having a stroke. The purpose of this study is to see if there are immediate changes in pushing behaviors in individuals who have had a stroke before and after sitting in a wheelchair, walking on the treadmill, and walking overground. The investigators do not think there will be a change with sitting in the wheelchair, but the investigators think there may be an improvement in pushing behaviors after walking training.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
6

participants targeted

Target at below P25 for not_applicable stroke

Timeline
Completed

Started May 2014

Longer than P75 for not_applicable stroke

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2014

Completed
20 days until next milestone

First Submitted

Initial submission to the registry

May 21, 2014

Completed
2 months until next milestone

First Posted

Study publicly available on registry

July 15, 2014

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2017

Completed
Last Updated

April 22, 2019

Status Verified

April 1, 2019

Enrollment Period

2.6 years

First QC Date

May 21, 2014

Last Update Submit

April 18, 2019

Conditions

Keywords

StrokePusher SyndromeLateropulsionPushing BehaviorsBurke Lateropulsion Scale

Outcome Measures

Primary Outcomes (1)

  • Burke Lateropulsion Scale

    Clinical measure of pushing behaviors in supine, sitting, standing, walking, and transfers will be performed before and after each 30 minute training session.

    Before and after each of 3 treatment sessions (3 separate days) over a maximum of a 10 day period

Study Arms (1)

wheelchair, walking on treadmill, walking overground

OTHER

Sitting in wheel chair Gait training on treadmill Gait training overground

Other: Sitting in wheel chairOther: Gait training on treadmillOther: Gait training overground

Interventions

Placebo/control intervention- No treatment, sitting in a wheelchair for 30 minutes

wheelchair, walking on treadmill, walking overground

Walking on a treadmill with or without body weight support during 30 minute treatment

wheelchair, walking on treadmill, walking overground

Walking overground with or without body weight support during 30 minute treatment

wheelchair, walking on treadmill, walking overground

Eligibility Criteria

Age18 Years - 89 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • score \>0 in each subsection of the Scale for Contraversive Pushing
  • admitted to the Rehabilitation Institute of Chicago inpatient rehabilitation setting
  • stroke within previous 180 days
  • consent to participate in the study
  • ambulating greater than 150' at a time prior to stroke

You may not qualify if:

  • other neurologic diagnoses
  • weight bearing precautions, orthopedic injuries, or other medical co-morbidities that prevent adherence to the study protocol

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Rehabilitation Hospital of the Pacific

Honolulu, Hawaii, 96817, United States

Location

Rehabilitation Institute of Chicago

Chicago, Illinois, 60611, United States

Location

MeSH Terms

Conditions

Stroke

Interventions

Sitting PositionWheelchairs

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

PostureMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological PhenomenaSelf-Help DevicesEquipment and Supplies

Study Officials

  • T. George Hornby, PT, PhD

    Rehabilitation Institute of Chicago, University of Illinois at Chicago

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

May 21, 2014

First Posted

July 15, 2014

Study Start

May 1, 2014

Primary Completion

December 1, 2016

Study Completion

December 1, 2017

Last Updated

April 22, 2019

Record last verified: 2019-04

Locations