NCT01789853

Brief Summary

The purpose of this study is to demonstrate the efficacy of intensive locomotor interventions early post stroke. An intensive locomotor training (LT) program will be compared to an active control, conventional physical therapy. It is proposed that an early and intensive stepping paradigm that is not typically employed early in physical therapy will lead to superior outcomes and improved community mobility. A randomized, blinded, controlled trial will test subjects with moderate to severe locomotor dysfunction in individuals post-stroke to compare walking-related outcomes after intensive gait training (including treadmill, overground, stair training, and skilled walking training) to outcomes after conventional physical therapy.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
56

participants targeted

Target at P50-P75 for not_applicable stroke

Timeline
Completed

Started Oct 2008

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2008

Completed
3.6 years until next milestone

First Submitted

Initial submission to the registry

May 14, 2012

Completed
9 months until next milestone

First Posted

Study publicly available on registry

February 12, 2013

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2015

Completed
Last Updated

September 9, 2015

Status Verified

September 1, 2015

Enrollment Period

6.8 years

First QC Date

May 14, 2012

Last Update Submit

September 8, 2015

Conditions

Stroke

Keywords

stroke, rehabilitation, gait training

Outcome Measures

Primary Outcomes (1)

  • Change in 10 meter walk test

    Gait speed

    Pre Test, 4 weeks, 8 weeks, 3 month follow up

Secondary Outcomes (2)

  • Change in 6 min walk test

    0, 4, 8 weeks post-training and 2 month follow-up

  • Change in Berg Balance Scale

    0. 4. 8 weeks post-training and 2 month follow-up

Study Arms (2)

Intensive Walking

EXPERIMENTAL

High intensity walking training in variable context for 8 weeks

Behavioral: Intensive Walking

Conventional Physical Therapy

ACTIVE COMPARATOR

Regular physical therapy for 8 weeks

Behavioral: Conventional Physical Therapy

Interventions

Intensive WalkingBEHAVIORAL

8 weeks high intensity walking training over multiple stepping tasks

Intensive Walking
Conventional Physical TherapyBEHAVIORAL

Regular physical therapy for 8 weeks

Conventional Physical Therapy

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • subacute (\<6 months) stroke
  • years old
  • history of history of unilateral, supratentorial, ischemic or hemorrhage stroke
  • able to walk 10m without physical assistance
  • gait speed less than or equal to .8m/s
  • medical clearance

You may not qualify if:

  • significant cardiorespiratory or metabolic disease that may limit exercise participation
  • weight limit \> 250 lbs (limit of most counter-weight safety systems)
  • history of previous orthopedic or neurological conditions which may impair walking.
  • women of childbearing potential will not be excluded, although women who are pregnant will be excluded due to potential forces at trunk from the harness applied at the waist.
  • subjects with scores \< 23 on the Mini Mental Status Exam
  • pacemaker
  • metal implants in the head region
  • history of epilepsy or seizures
  • skull fractures or skull deficits
  • concussion within the last 6 months
  • unexplained recurring headaches
  • medications that lower seizure threshold
  • pregnancy
  • aneurysm clip or coil
  • metal or wire implants
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rehabilitation Institute of Chicago

Chicago, Illinois, 60611, United States

Location

Related Publications (3)

  • Hornby TG, Rafferty MR, Pinto D, French D, Jordan N. Cost-Effectiveness of High-intensity Training vs Conventional Therapy for Individuals With Subacute Stroke. Arch Phys Med Rehabil. 2022 Jul;103(7S):S197-S204. doi: 10.1016/j.apmr.2021.05.017. Epub 2021 Jul 3.

    PMID: 34228956DERIVED

  • Hornby TG, Henderson CE, Holleran CL, Lovell L, Roth EJ, Jang JH. Stepwise Regression and Latent Profile Analyses of Locomotor Outcomes Poststroke. Stroke. 2020 Oct;51(10):3074-3082. doi: 10.1161/STROKEAHA.120.031065. Epub 2020 Sep 4.

    PMID: 32883192DERIVED

  • Hornby TG, Holleran CL, Hennessy PW, Leddy AL, Connolly M, Camardo J, Woodward J, Mahtani G, Lovell L, Roth EJ. Variable Intensive Early Walking Poststroke (VIEWS): A Randomized Controlled Trial. Neurorehabil Neural Repair. 2016 Jun;30(5):440-50. doi: 10.1177/1545968315604396. Epub 2015 Sep 3.

    PMID: 26338433DERIVED

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • George T Hornby, PT, PhD

    Shirley Ryan AbilityLab

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
T. George Hornby, PT, PhD

Study Record Dates

First Submitted

May 14, 2012

First Posted

February 12, 2013

Study Start

October 1, 2008

Primary Completion

August 1, 2015

Study Completion

August 1, 2015

Last Updated

September 9, 2015

Record last verified: 2015-09

Locations

US(1)