Locomotor Experience Applied Post Stroke Trial "LEAPS"

Completed

Phase 3 Results

Trial Description

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

Detailed 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).

Conditions

Interventions

  • Robotic Aids Behavioral
    Intervention Desc: This category includes any mechanical and/or computerized device designed to improve extremity function.
  • Body weight training program with treadmill Drug
  • Physical therapist-monitored exercise program Drug
  • A non-specific low intensity exercise program Drug
  • Early locomotor training program Behavioral
    Other Names: E-LTP; LTP-early
    Intervention Desc: 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.
    ARM 1: Kind: Experimental
    Label: Early Locomotor Training Program
    Description: body weight supported training program with treadmill
  • Late locomotor training program Behavioral
    Other Names: L-LTP; LTP-late
    Intervention Desc: 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.
    ARM 1: Kind: Experimental
    Label: Late Locomotor Training Program
    Description: body weight supported training program with treadmill
  • Home Exercise Program Behavioral
    Other Names: HEP
    Intervention Desc: Participants in the early home exercise group will receive a non-specific low intensity exercise program beginning at 2 months post stroke.
    ARM 1: Kind: Experimental
    Label: Early Home Exercise Program
    Description: a non-specific low intensity exercise program

Trial Design

  • Allocation: Randomized
  • Masking: Open Label
  • Purpose: Treatment
  • Intervention: Parallel Assignment

Patient Involvement

Patients will be randomized into one of three groups: early locomotor (beginning at 2 months post-stroke), late locomotor (beginning at 6 months post-stroke), or early home exercise (beginning at 2 months post-stroke). The locomotor groups will utilize a body weight support system and a treadmill and the home exercise group will receive non-specific low intensity exercise training. All three groups will train for 12 weeks, 3 times per week to complete a total of 36 sessions.

Outcomes

Type Measure Time Frame Safety Issue
Primary Gait speed: measured during a 10-meter walk; Success: walking greater than 0.4 m/sec if baseline was 0.4; walking greater than 0.8 m/sec if baseline was. 4m/sec or greater but less 0.8 m/sec.
Secondary The distance a person can walk; the amount of daily walking that a person is willing and able to do.
Primary Gait speed: measured during a 10-meter walk duration of the trial No
Primary Success: walking greater than 0.4 m/sec if baseline was 0.4; walking greater than 0.8 m/sec if baseline was 0.4m/sec or greater but less 0.8 m/sec duration of the trial No
Secondary The distance a person can walk duration of the trial No
Secondary The amount of daily walking that a person is willing and able to do duration of the trial No
Primary Percentage of Patients Who Successfully Improved Functional Level of Walking at 1 Year Post-stroke Baseline and 12 months No
Primary Walking Speed: Measured During a 10-meter Walk Baseline and 12 months No
Secondary Percentage of Patients Who Successfully Improved Functional Level of Walking at 6 Months Post-stroke Baseline and 6 months No
Secondary 6 Month Outcome: Walking Speed: Measured During a 10-meter Walk Baseline and 6 months No
Secondary 6 Minute Walking Distance (Meters) Baseline, 6 months and 12 months No
Secondary Step Activity Monitor (SAM)- Median of Average Number of Steps Per Day Baseline, 6 months and 12 months No
Secondary Stroke Impact Scale (SIS) - Participation Baseline, 6 months and 12 months No
Secondary Stroke Impact Scale (SIS) - Activities of Daily Living/Instrumental Activities of Daily Living (ADL/IADL) Baseline, 6 months and 12 months No
Secondary Stroke Impact Scale (SIS) - Mobility Baseline, 6 months and 12 months No
Secondary Fugl-Meyer Lower Extremity Score Baseline, 6 months and 12 months No
Secondary Berg Balance Score Baseline, 6 months and 12 months No
Secondary Activities Specific Balance Confidence (ABC) Score Baseline, 6 months and 12 months No

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