NCT00389012

Brief Summary

The purpose of this study is to determine if treadmill training with body weight-support (BWST) is more effective at improving walking in individuals post-stroke than a resisted leg-cycling exercise program. In addition, we want to determine if training programs that combine leg strength training to treadmill walking provide an additional benefit to post-stroke walking outcomes.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
80

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started May 2004

Longer than P75 for phase_2

Geographic Reach
1 country

3 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, 2004

Completed
2.5 years until next milestone

First Submitted

Initial submission to the registry

October 16, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 17, 2006

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 31, 2010

Completed
Last Updated

April 6, 2017

Status Verified

April 1, 2010

Enrollment Period

6.5 years

First QC Date

October 16, 2006

Last Update Submit

April 4, 2017

Conditions

Cerebrovascular Accident

Keywords

rehabilitationhemiplegic gaitexercise therapyphysical therapy

Outcome Measures

Primary Outcomes (2)

  • walking speed (meters/second)

  • walking distance (distance walked in 6-minutes)

Secondary Outcomes (5)

  • Lower extremity Fugl-Meyer

  • Berg Balance Score

  • Lower extremity torque

  • Stroke Impact Scale

  • SF-36

Interventions

exercise therapyPROCEDURE
walking rehabilitationPROCEDURE

Eligibility Criteria

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

You may qualify if:

  • age 18 years or older
  • months to 5 years after first-time onset of a ischemic or hemorrhagic cerebrovascular accident (CVA) confirmed by CT, MRI, or clinical criteria
  • able to ambulate at least 14 meters with assistive and/or orthotic device and one person assist (minimum Functional Ambulation Classification Level II
  • self-selected walking velocity of ≤1.0 meters/second
  • approval of primary care physician to participate.

You may not qualify if:

  • resting systolic blood pressure greater than 180mmHg and/or diastolic blood pressure greater than 110mmHg and/or resting heart rate greater than 100 beats/minute;
  • lower limb orthopedic conditions such as prior joint replacement or range of motion limitations;
  • spasticity management that included Botox injection (\< 4 months earlier) or phenol block injection (\< 12 months earlier) to affected lower extremity and intrathecal Baclofen or oral Baclofen (within past 30 days);
  • Mini-Mental State Exam score \< 24;
  • currently receiving lower extremity strengthening exercises or gait training,
  • past participation in any study examining the effects of long term (\>4 weeks training) body weight support treadmill training; limb loaded pedaling, or lower extremity strengthening;
  • plans to move out of the area in the next year,
  • no transportation to the study site for all evaluations and intervention sessions.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Rancho Los Amigos

Downey, California, 90242, United States

Location

University of Southern California

Los Angeles, California, 90089, United States

Location

Northwestern University

Chicago, Illinois, 60611, United States

Location

Related Publications (1)

  • Sullivan KJ, Brown DA, Klassen T, Mulroy S, Ge T, Azen SP, Winstein CJ; Physical Therapy Clinical Research Network (PTClinResNet). Effects of task-specific locomotor and strength training in adults who were ambulatory after stroke: results of the STEPS randomized clinical trial. Phys Ther. 2007 Dec;87(12):1580-602. doi: 10.2522/ptj.20060310. Epub 2007 Sep 25.

    PMID: 17895349DERIVED

MeSH Terms

Conditions

StrokeGait Disorders, Neurologic

Interventions

Exercise Therapy

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

RehabilitationAftercareContinuity of Patient CarePatient CareTherapeuticsPhysical Therapy Modalities

Study Officials

  • Katherine J Sullivan, PhD, PT

    Division of Biokinesiology and Physical Therapy, University of Southern California, Los Angeles, California

    PRINCIPAL INVESTIGATOR

  • David A Brown, PhD, PT

    Department of Physical Therapy and Movement Sciences, Feinberg School of Medicine, Northwestern University, Chicago, Illinois

    PRINCIPAL INVESTIGATOR

  • Sara Mulroy, PhD, PT

    Pathokinesiology Laboratory, Rancho Los Amigos National Rehabilitation Center, Downey, California

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
SINGLE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 16, 2006

First Posted

October 17, 2006

Study Start

May 1, 2004

Primary Completion

October 31, 2010

Study Completion

October 31, 2010

Last Updated

April 6, 2017

Record last verified: 2010-04

Locations

US(3)