Locomotor Experience Applied Post Stroke Trial

Stroke Clinical Trial

— LEAPS  

Official title:

Locomotor Experience Applied Post Stroke (LEAPS) Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00243919
• Other study ID #: Pro00006846
• Secondary ID: R01NS050506
• Status: Completed
• Phase: Phase 3
• First received: October 24, 2005
• Last updated: July 9, 2014
• Start date: April 2006
• Est. completion date: June 2012

Study information

• Verified date: December 2012
• Source: Duke University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial Summary

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

Description:

The impact of stroke on walking is significant, with only 37 percent of stroke survivors able to walk after the first week after stroke (or post-stroke). Even among those who achieve independent ambulation, significant residual deficits persist in balance and gait speed with a 73 percent incidence of falls among individuals with mild to moderate impairment 6 months post-stroke. Body weight supported treadmill training is one therapeutic method for locomotor training that is rapidly being adopted into physical rehabilitation to improve walking after stroke.

The purpose of this multi-center, randomized controlled study is to compare two different treatments to improve walking after stroke. The two treatments are: 1) a training program that includes use of a body weight support system and a treadmill to practice walking and 2) a physical therapist monitored exercise program to work on general conditioning and strengthening in the patient's home. In addition, investigators will determine the best time to provide training after a stroke and if the training is beneficial for mild, moderate, or severe cases of stroke.

Four hundred subjects will be recruited from five facilities in Florida and California. Screening and subject recruitment will take place within 45 days post-stroke. All stroke patients will be screened to determine eligibility for the study. Eligible subjects will be followed for 2 months post-stroke. At that time, those who are eligible for enrollment and who consent to participate will undergo an exercise tolerance test and baseline assessment. Following this evaluation, participants will be randomized into one of three groups, according to the severity of their locomotor impairment: early locomotor, late locomotor, or early home exercise.

The early locomotor training group will begin the locomotor training program immediately (2 months post stroke). The 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. The late locomotor training group will begin locomotor training at 6 months post-stroke. Participants in the early home exercise group will receive a non-specific low intensity exercise program beginning immediately (2 months post stroke).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 408
• Est. completion date: June 2012
• Est. primary completion date: April 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

• Major post-stroke depression as measured by the Patient Health Questionnaire(PHQ-9 >/= 10) that is not medically managed with antidepressant medication and/or psychotherapy

• History of pulmonary embolism within 6 months

• Uncontrollable diabetes with recent weight loss, diabetic coma, or frequent insulin reactions

• Severe hypertension with systolic greater than 200 mmHg and diastolic greater than 110 mmHg at rest,

• Previous or current enrollment in a clinical trial to enhance stroke motor recovery

• Lives more than 50 miles from the training sites

• Unable to travel 3 times per week for outpatient training programs

• Intracranial hemorrhage related to aneurysmal rupture or an arteriovenous malformation (hemorrhagic infarctions will not be excluded)

Inclusion and exclusion criteria will be determined by a chart review, depression screen and subject interview by study physician or study coordinator. After initial chart and subject interview, each subject's treating physician will be asked to review inclusion and exclusion criteria and provide a letter supporting inclusion in the study. All subjects who meet selection criteria must successfully complete an exercise tolerance test

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Stroke

Intervention

Behavioral:
• Early locomotor training program
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.
• Late locomotor training program
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.
• Home Exercise Program
Participants in the early home exercise group will receive a non-specific low intensity exercise program beginning at 2 months post stroke.

Locations

Country	Name	City	State
United States	Duke University (Administrative Coordinating Center)	Durham	North Carolina
United States	University of Florida	Gainesville	Florida
United States	Centinela Freeman Memorial Hospital	Inglewood	California
United States	Brooks Rehabilitation Hospital	Jacksonville	Florida
United States	Long Beach Memorial Hospital	Long Beach	California
United States	University of Southern California - PT Associates	Los Angeles	California
United States	Florida Hospital	Orlando	Florida
United States	Sharp Memorial Rehabilitation Center	San Diego	California

Sponsors (2)

Lead Sponsor	Collaborator
Duke University	National Institute of Neurological Disorders and Stroke (NINDS)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	Walking Speed: Measured During a 10-meter Walk		Baseline and 12 months post-stroke	No
Secondary	Percentage of Patients Who Successfully Improved Functional Level of Walking at 6 Months 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.	Baseline and 6 months post-stroke	No
Secondary	6 Month Outcome: Walking Speed: Measured During a 10-meter Walk		Baseline and 6 months post-stroke	No
Secondary	6 Minute Walking Distance (Meters)	Distance walked in 6 minutes.	Baseline, 6 months and 12 months post-stroke	No
Secondary	Step Activity Monitor (SAM)- Median of Average Number of Steps Per Day	As measured with a step activity monitor averaged over 2 days.	Baseline, 6 months and 12 months post-stroke	No
Secondary	Stroke Impact Scale (SIS) - Participation	Range = 0 - 100. The Stroke Impact Scale is a measure of function (including ADL-IADL and mobility) and quality of life (participation). The Participation Scale is a single domain of the Stroke Impact Scale in which participation is defined as the ability to engage in meaningful activities with 0 indicating inability to engage in any meaningful activities and 100 indicating the ability to fully engage in meaningful activities.	Baseline, 6 months and 12 months post-stroke	No
Secondary	Stroke Impact Scale (SIS) - Activities of Daily Living/Instrumental Activities of Daily Living (ADL/IADL)	Range 0 - 100 The Stroke Impact Scale (SIS) is a measure of function including ADL/IADL. The ADL/IADL scale is a single domain of the Stroke Impact Scale in which ADL is defined as the ability to take care of basic needs and IADL is defined as the ability to perform activities that make it possible to live independently in the community, with 0 indicating complete dependence on others and 100 indicating the ability to live independently without difficulty.	Baseline, 6 months and 12 months post-stroke	No
Secondary	Stroke Impact Scale (SIS) - Mobility	Range = 0 - 100. The Stroke Impact Scale (SIS) is a measure of function including Mobility. The Mobility scale is a single domain of the Stroke Impact Scale which captures the ability to balance and move, with 0 indicating severe restrictions in balance and mobility and 100 indicating independence in mobility and balance.	Baseline, 6 months and 12 months post-stroke	No
Secondary	Fugl-Meyer Lower Extremity Score	Range 0 - 34 The Fugl-Meyer Lower Extremity Score measures your ability to move the lower extremity with 0 indicating no movement and 34 indicating the ability to selectively move the lower extremity without difficulty.	Baseline, 6 months and 12 months post-stroke	No
Secondary	Berg Balance Score	Range = 0 - 56 The Berg Balance Score assesses balance in sitting, standing, reaching, shifting weight and turning, with 0 defined as inability to balance and 56 defined as the ability to balance independently and without difficulty while performing each task.	Baseline, 6 months and 12 months post-stroke	No
Secondary	Activities Specific Balance Confidence (ABC) Score	Range = 0 - 100 The ABC scale is a self reported measure of confidence with activities such as walking around the house, standing on a chair to reach or getting out of a car without losing balance or becoming unsteady. A score of 0 indicates no confidence that the activities can be performed without losing balance and a score 100 indicates confidence that the activities can be accomplished without losing balance.	Baseline, 6 months and 12 months post-stroke	No