Phase 3
Completed N=408
Locomotor Experience Applied Post Stroke Trial
Source: ClinicalTrials.gov NCT00243919 ↗Enrolled (actual)
408
Serious AEs
36.5%
Results posted
Sep 2011
Primary outcomePrimary: Percentage of Patients Who Successfully Improved Functional Level of Walking at 1 Year Post-stroke — 50.4; 53.8; 51.6 percent of participants — p=0.481
Summary
The purpose of this study is to compare two different treatments to improve walking after stroke (or post-stroke).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Patients Who Successfully Improved Functional Level of Walking at 1 Year Post-stroke |
50.4; 53.8; 51.6 | 0.481 |
| PRIMARY Walking Speed: Measured During a 10-meter Walk |
0.37; 0.38; 0.39; 0.23; 0.24; 0.25 | 0.242 |
| SECONDARY Percentage of Patients Who Successfully Improved Functional Level of Walking at 6 Months Post-stroke |
50.4; 32.2; 49.2 | 0.010 sig |
| SECONDARY 6 Month Outcome: Walking Speed: Measured During a 10-meter Walk |
0.37; 0.38; 0.39; 0.25; 0.13; 0.23 | <0.0001 sig |
| SECONDARY 6 Minute Walking Distance (Meters) |
124.1; 125.7; 126.3; 81.8; 41.0; 75.9 | 0.45 |
| SECONDARY Step Activity Monitor (SAM)- Median of Average Number of Steps Per Day |
1468; 1664; 1882.5; 1017; 565.5; 1357 | 0.10 |
| SECONDARY Stroke Impact Scale (SIS) - Participation |
45.0; 46.6; 44.8; 11.8; 7.7; 14.7 | 0.48 |
| SECONDARY Stroke Impact Scale (SIS) - Activities of Daily Living/Instrumental Activities of Daily Living (ADL/IADL) |
54.1; 55.7; 54.4; 9.8; 7.0; 13.0 | 0.07 |
| SECONDARY Stroke Impact Scale (SIS) - Mobility |
57.0; 60.5; 59.1; 15.3; 7.0; 14.9 | 0.69 |
| SECONDARY Fugl-Meyer Lower Extremity Score |
23.7; 24.8; 24.7; 2.2; 1.3; 2.4 | 0.13 |
| SECONDARY Berg Balance Score |
35.0; 35.9; 36.5; 8.8; 5.3; 7.9 | 0.06 |
| SECONDARY Activities Specific Balance Confidence (ABC) Score |
43.6; 47.0; 44.5; 13.8; 6.2; 15.6 | 0.62 |
Eligibility Criteria
Inclusion Criteria
- Age >/=18
- Stroke within 45-days
- Residual paresis in the lower extremity (fugl-meyer le motor score 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
Data sourced from ClinicalTrials.gov (NCT00243919). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.