NCT02516176

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
38

participants targeted

Target at P25-P50 for not_applicable stroke

Timeline
Completed

Started Feb 2015

Longer than P75 for not_applicable stroke

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2015

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

July 22, 2015

Completed
14 days until next milestone

First Posted

Study publicly available on registry

August 5, 2015

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2019

Completed
Last Updated

March 13, 2019

Status Verified

March 1, 2019

Enrollment Period

4.1 years

First QC Date

July 22, 2015

Last Update Submit

March 11, 2019

Conditions

Keywords

strokecerebral vascular accidentbalancetreadmillfallshemiparesis

Outcome Measures

Primary Outcomes (1)

  • 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

    change from baseline at 3 weeks - immediately following the training sessions

Study Arms (1)

Treadmill Training

EXPERIMENTAL

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

Behavioral: treadmill training

Interventions

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

Treadmill Training

Eligibility Criteria

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

You may qualify if:

  • 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

You may not qualify if:

  • 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.
  • other major musculoskeletal or neurological disorders

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Northwestern University

Chicago, Illinois, 60611, United States

Location

MeSH Terms

Conditions

StrokeParesis

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Lois D Hedman, DSc PT

    Northwestern University

    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
Associate Professor of Physical Therapy

Study Record Dates

First Submitted

July 22, 2015

First Posted

August 5, 2015

Study Start

February 1, 2015

Primary Completion

March 1, 2019

Study Completion

March 1, 2019

Last Updated

March 13, 2019

Record last verified: 2019-03

Data Sharing

IPD Sharing
Will not share

Locations