N/A
N=16
Metabolic Costs of Walking Post Stroke
Acute Stroke
Bottom Line
View on ClinicalTrials.gov: NCT02108912 ↗Enrolled (actual)
16
Serious AEs
0.0%
Results posted
Mar 2019
Primary outcome: Primary: Maximum Exercise Tolerance Testing
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- ESTT (Other); Traditional outpatient (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Texas Southwestern Medical Center
- Primary completion
- Jan 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Maximum Exercise Tolerance Testing |
— | — |
| PRIMARY Change in 6-Minute Walk Test Distance |
469.3; 529.2 | — |
Summary
This will be a randomized, matched-group study to compare the cardiopulmonary / metabolic benefits for persons post stroke that learn to walk utilizing early treadmill training post-acute stroke to persons post stroke that learn to walk utilizing non-treadmill based gait training during the same time period. Participants (n=30) will be adults who have completed acute rehabilitation following a stroke. Random assignment will be to either the ESTT or traditional gait training protocol during the outpatient rehabilitation phase.
1. Group A: Traditional outpatient therapy (n = 15)
2. Group B: Treadmill training (ESTT) outpatient therapy (n = 15)
Eligibility Criteria
Inclusion Criteria
- confirmed diagnosis of recent cerebrovascular accident (CVA) (less than 6 weeks post at the time of admission to inpatient rehabilitation)
- able to give informed consent independently or have family member or other authorized surrogate available to give consent
- first time stroke OR complete gait recovery from prior stroke
- sufficient support at home to participate in home-based fitness training program
- transportation to University of Texas Southwestern Medical Center Gait Disorders Clinic (UTSW GDC) for therapy and testing
- ability to follow one-part commands
Exclusion Criteria
- non-ambulatory before onset of stroke (at time of admission to inpatient rehabilitation)
- bilateral stroke
- presence of severe cardiac problems (heart failure [New York Heart Association > Class 2], unstable or exercise-induced angina)
- other co-morbidities which could affect gait training (i.e. amputation, spinal cord injury, traumatic brain injury, etc.)
- recent myocardial infarct (within 4 weeks of date of inpatient rehabilitation admission)
- any uncontrolled health condition for which exercise is contraindicated
- severe lower extremity joint disease/pathology that would interfere with gait training
- subjects -with body mass index (BMI) greater than 40
- significant cognitive impairment (less than 2 on the Functional Independence Measure [FIM] cognitive sub-scale)
- age greater than 80 years or less than 18 years
- able to complete 5 or more full heel raises with the affected ankle in standing with the knee extended with no more than one or two fingers on support surface for balance
Data sourced from ClinicalTrials.gov (NCT02108912). 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.