N/A
N=36
Locomotor Training (Walking Therapy) Post Stroke
Stroke
Bottom Line
View on ClinicalTrials.gov: NCT00715299 ↗Enrolled (actual)
36
Serious AEs
0.0%
Results posted
Mar 2015
Primary outcome: Primary: The Primary Outcome Measure Was Pre-treatment to Post-treatment Change in Self-selected Walking Speed. — 0.21 meters per second
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- locomotor training (Behavioral)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- US Department of Veterans Affairs
- Primary completion
- Oct 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY The Primary Outcome Measure Was Pre-treatment to Post-treatment Change in Self-selected Walking Speed. |
0.21 | — |
Summary
This is a research study to examine a new type of walking therapy for people after they have had a stroke. We will study how people move and how their muscles work to see how the therapy helps people to walk better and to see how the therapy can be improved.
Eligibility Criteria
Inclusion Criteria
- age >= 18,
- stroke within past 6 months to 5 years,
- 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 (PHQ-9 10),
- History of deep venous thrombosis or 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, and
- 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 project coordinator. After initial chart and subject interview, each subject's treating physician will be asked to review our 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 (NCT00715299). 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.