Locomotor Experience Applied Post Stroke Trial

NCT00243919 | Completed Phase 3 Results

• 2 other identifiers: Pro00006846R01NS050506
• Study Type: interventional
• Target: 408
• Locations: 1 country
• Sites: 8

Brief Summary

The purpose of this study is to compare two different treatments to improve walking after stroke (or post-stroke).

Conditions

Stroke

Keywords

stroke; locomotor; exercise; walking; training program; body weight support training; physical therapy

Outcome Measures

Primary Outcomes (2)

• Percentage of Patients Who Successfully Improved Functional Level of Walking at 1 Year Post-stroke

  Success: walking greater than 0.4 m/sec if baseline was less than 0.4; walking greater than 0.8 m/sec if baseline was 0.4m/sec or greater but less than 0.8 m/sec as measured during 10 meter walk.

  12 months post-stroke

• Walking Speed: Measured During a 10-meter Walk

  Baseline and 12 months post-stroke

Secondary Outcomes (10)

• Percentage of Patients Who Successfully Improved Functional Level of Walking at 6 Months Post-stroke

  Baseline and 6 months post-stroke

• 6 Month Outcome: Walking Speed: Measured During a 10-meter Walk

  Baseline and 6 months post-stroke

• 6 Minute Walking Distance (Meters)

  Baseline, 6 months and 12 months post-stroke

• Step Activity Monitor (SAM)- Median of Average Number of Steps Per Day

  Baseline, 6 months and 12 months post-stroke

• Stroke Impact Scale (SIS) - Participation

  Baseline, 6 months and 12 months post-stroke

Study Arms (3)

Early Locomotor Training Program

ACTIVE COMPARATOR

body weight supported training program with treadmill

Behavioral: Early locomotor training program

Late Locomotor Training Program

ACTIVE COMPARATOR

body weight supported training program with treadmill

Behavioral: Late locomotor training program

Early Home Exercise Program

ACTIVE COMPARATOR

a non-specific low intensity exercise program

Behavioral: Home Exercise Program

Interventions

Early locomotor training program BEHAVIORAL

The early locomotor training program is an out-patient program of locomotor training for 36 sessions, 3 times per week, using a body weight support system and stepping on a treadmill and overground training beginning at 2 months post-stroke.

Also known as: E-LTP, LTP-early

Early Locomotor Training Program

Late locomotor training program BEHAVIORAL

The late locomotor training program is an out-patient program of locomotor training for 36 sessions, 3 times per week, using a body weight support system and stepping on a treadmill and overground training beginning at 6 months post-stroke.

Also known as: L-LTP, LTP-late

Late Locomotor Training Program

Home Exercise Program BEHAVIORAL

Participants in the early home exercise group will receive a non-specific low intensity exercise program beginning at 2 months post stroke.

Also known as: HEP

Early Home Exercise Program

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age \>/=18
• Stroke within 45-days
• Residual paresis in the lower extremity (fugl-meyer le motor score \< 34)
• Ability to sit unsupported for 30 seconds
• Ability to walk at least 10 feet with maximum 1 person assist
• Ability to follow a three step command
• Provision of informed consent
• A self-selected 10 meter gait speed less than 0.8 m/s at the 2-month post-stroke assessment
• Successful completion of an exercise tolerance test

You may not qualify if:

• Lived in nursing home prior to stroke
• Unable to ambulate at least 150 feet prior to stroke, or experienced intermittent claudication while walking less than 200 meters
• Serious cardiac conditions (history of congestive heart failure, documented serious and unstable cardiac arrhythmias, hypertrophic cardiomyopathy, severe aortic stenosis, angina or dyspnea at rest or during activities of daily living). Anyone meeting New York Heart Association criteria for Class 3 or Class 4 heart disease will be excluded
• History of serious chronic obstructive pulmonary disease or oxygen dependence
• Severe weight bearing pain
• Preexisting neurological disorders such as Parkinson's disease, Amyotrophic Lateral Sclerosis (ALS), Multiple Sclerosis (MS), dementia, or previous stroke with residual neurological deficits
• History of major head trauma
• Lower extremity amputation
• Non-healing ulcers on the lower extremity
• Renal dialysis or end stage liver disease
• Legal blindness or severe visual impairment
• A history of significant psychiatric illness defined by diagnosis of bipolar affective disorder, psychosis, schizophrenia or medication refractory depression
• Life expectancy less than one year
• Severe arthritis or orthopedic problems that limit passive ranges of motion of lower extremity (knee flexion contracture of -10°, knee flexion Range of Motion (ROM) \< 90°, hip flexion contracture \> 25°, and ankle plantar flexion contracture \> 15°
• History of sustained alcoholism or drug abuse in the last six months

Sponsors & Collaborators

• Duke University: lead
• National Institute of Neurological Disorders and Stroke (NINDS): collaborator

Study Sites (8)

Centinela Freeman Memorial Hospital

Inglewood, California, United States

Location

Long Beach Memorial Hospital

Long Beach, California, United States

Location

University of Southern California - PT Associates

Los Angeles, California, United States

Location

Sharp Memorial Rehabilitation Center

San Diego, California, United States

Location

University of Florida

Gainesville, Florida, United States

Location

Brooks Rehabilitation Hospital

Jacksonville, Florida, United States

Location

Florida Hospital

Orlando, Florida, United States

Location

Duke University (Administrative Coordinating Center)

Durham, North Carolina, United States

Location

Related Publications (6)

• Seamon BA, Kautz SA, Velozo CA. Measurement Precision and Efficiency of Computerized Adaptive Testing for the Activities-specific Balance Confidence Scale in People With Stroke. Phys Ther. 2021 Apr 4;101(4):pzab020. doi: 10.1093/ptj/pzab020.

  PMID: 33481989 DERIVED

• Nadeau SE, Dobkin B, Wu SS, Pei Q, Duncan PW; LEAPS Investigative Team. The Effects of Stroke Type, Locus, and Extent on Long-Term Outcome of Gait Rehabilitation: The LEAPS Experience. Neurorehabil Neural Repair. 2016 Aug;30(7):615-25. doi: 10.1177/1545968315613851. Epub 2015 Oct 23.

  PMID: 26498434 DERIVED

• Nadeau SE, Wu SS, Dobkin BH, Azen SP, Rose DK, Tilson JK, Cen SY, Duncan PW; LEAPS Investigative Team. Effects of task-specific and impairment-based training compared with usual care on functional walking ability after inpatient stroke rehabilitation: LEAPS Trial. Neurorehabil Neural Repair. 2013 May;27(4):370-80. doi: 10.1177/1545968313481284. Epub 2013 Mar 15.

  PMID: 23504552 DERIVED

• Tilson JK, Wu SS, Cen SY, Feng Q, Rose DR, Behrman AL, Azen SP, Duncan PW. Characterizing and identifying risk for falls in the LEAPS study: a randomized clinical trial of interventions to improve walking poststroke. Stroke. 2012 Feb;43(2):446-52. doi: 10.1161/STROKEAHA.111.636258. Epub 2012 Jan 12.

  PMID: 22246687 DERIVED

• Duncan PW, Sullivan KJ, Behrman AL, Azen SP, Wu SS, Nadeau SE, Dobkin BH, Rose DK, Tilson JK, Cen S, Hayden SK; LEAPS Investigative Team. Body-weight-supported treadmill rehabilitation after stroke. N Engl J Med. 2011 May 26;364(21):2026-36. doi: 10.1056/NEJMoa1010790.

  PMID: 21612471 DERIVED

• Duncan PW, Sullivan KJ, Behrman AL, Azen SP, Wu SS, Nadeau SE, Dobkin BH, Rose DK, Tilson JK; LEAPS Investigative Team. Protocol for the Locomotor Experience Applied Post-stroke (LEAPS) trial: a randomized controlled trial. BMC Neurol. 2007 Nov 8;7:39. doi: 10.1186/1471-2377-7-39.

  PMID: 17996052 DERIVED

MeSH Terms

Conditions

Stroke; Motor Activity

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Behavior

Results Point of Contact

• Title: Pamela W. Duncan, PT, PhD, FAHA, FAPTA
• Organization: Duke University

pamela.duncan@duke.edu

919-681-2060

Study Officials

• Pamela W. Duncan, PhD, PT, FAPTA, FAHA

  Professor and Bette Busch Maniscalco, Doctor of Physical Therapy Division, Research Fellow, Department of Community and Family Medicine, Duke Center for Clinical Health Policy Research

  PRINCIPAL INVESTIGATOR

• Katherine J. Sullivan, Ph.D., PT

  Co-Principal Investigator, Division of Biokinesiology and Physical Therapy, University of Southern California, Los Angeles, California

  PRINCIPAL INVESTIGATOR

• Andrea L. Behrman, Ph.D., PT

  Co-Principal Investigator, Department of Physical Therapy, Brooks Center for Rehabilitation Studies, University of Florida, and Department of Veteran Affairs Brain Rehabilitation Research Center, Gainesville, Florida

  PRINCIPAL INVESTIGATOR

• Stanley P. Azen, Ph.D.,

  Director Data Management Core, Biostatistics Division, Department of Preventive Medicine, University of Southern California, Los Angeles, California

  STUDY DIRECTOR

• Samuel S. Wu, Ph.D.

  Lead Biostatistician - Investigator, Department of Epidemiology and Health Policy Research, University of Florida

  STUDY DIRECTOR

• Bruce H. Dobkin, MD

  Investigator, Department of Neurology, University of California, Los Angeles, California

  STUDY DIRECTOR

• Stephen E. Nadeau, MD

  Investigator, Geriatric Research, Education and Clinical Center and the Brain Rehabilitation Research Center, Gainesville VA Medical Center, and the Department of Neurology, University of Florida College of Medicine, Gainesville, Fl

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 24, 2005
• First Posted: October 25, 2005
• Study Start: April 1, 2006
• Primary Completion: April 1, 2010
• Study Completion: June 1, 2012
• Last Updated: July 16, 2014
• Results First Posted: September 22, 2011

Record last verified: 2012-12

Locations

US (8)