Incline Training to Personalize Motor Control Interventions After Stroke
- Conditions
- CVA (Cerebrovascular Accident)
- Interventions
- Other: Level Treadmill (Control)Other: Decline treadmill walkingOther: Incline treadmill walking
- Registration Number
- NCT03561246
- Lead Sponsor
- VA Office of Research and Development
- Brief Summary
This study will evaluate the use of incline and decline treadmill training to address specific motor control deficits identified within different post-stroke walking patterns.
- Detailed Description
This study seeks to develop a theory-based clinical decision-making framework for the training of walking recovery after stroke based on how different biomechanical patterns of walking illustrate distinct motor control deficits. Each participant will complete 12 sessions (three times a week for four weeks) of either INCLINE, DECLINE, or CONTROL training. Clinical and biomechanical outcome measures will be collected pre- and post-training and after a one-month follow-up period. In addition, the investigators will collect a battery of clinical outcome measures before and after training. Spatiotemporal variables (including SSWS) will be collected before and after each session. All clinical and biomechanical assessments will be conducted by an evaluator blinded to training group allocation.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 55
- stroke 6 months
- residual paresis in the lower extremity (Fugl-Meyer LE motor score <34)
- ability to walk without assistance at speeds ranging from 0.2 - 1.0 m/s (with a support harness for biomechanical testing)
- Ability to walk on a treadmill without orthotic or assistive device using overhead harness system
- provision of informed consent, and 8) written approval from the primary physician (see attached sample of Medical Approval Cover Letter).
- history of congestive heart failure, unstable cardiac arrhythmias, hypertrophic cardiomyopathy, severe aortic stenosis, angina or dyspnea at rest or during ADLs
- History of COPD or oxygen dependence
- Pre-existing neurological disorders or dementia
- History of major head trauma
- Pp between 0.47 and 0.53
- Legal blindness or severe visual impairment
- Severe arthritis or other problems that limit passive ROM
- History of DVT or pulmonary embolism within 6 months
- Severe hypertension with systolic >200 mmHg and diastolic >110 mmHg at rest.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Personalized training effect on SSWS and Pp - Level treadmill (Control) Level Treadmill (Control) Determine the efficacy of motor control deficit guided personalized training on SSWS and Paretic Propulsion (Pp). Level treadmill walking: Those with a Pp \<0.47 or \>0.53 will undergo LEVEL training during which individuals will walk for 15 minutes at a 0-degree treadmill tilt, stopping each five minutes for monitoring of vital signs. Personalized training effect on SSWS and Pp - Decline Decline treadmill walking Determine the efficacy of motor control deficit guided personalized training on SSWS and Paretic Propulsion (Pp). Decline treadmill walking: Those with a Pp \<0.47 or \>0.53 will undergo DECLINE training during which individuals will walk for 15 minutes at a 10-degree treadmill tilt, stopping each five minutes for monitoring of vital signs. Personalized training effect on SSWS and Pp - Incline Incline treadmill walking Determine the efficacy of motor control deficit guided personalized training on SSWS and Paretic Propulsion (Pp). Incline treadmill walking: Those with a Pp \<0.47 or \>0.53 will undergo INCLINE training during which individuals will walk for 15 minutes at a 10-degree treadmill tilt, stopping each five minutes for monitoring of vital signs.
- Primary Outcome Measures
Name Time Method Change in Gait Speed Pre (same day but prior to initial training session) and post (immediately following final training session) approximately 4 weeks apart. Participants will be asked to complete a 10 Meter Walk Test and a difference will be calculated between pre and post speed.
- Secondary Outcome Measures
Name Time Method Change in Paretic Propulsion Symmetry Pre (same day but prior to initial training session) and post (immediately following final training session) approximately 4 weeks apart. Quantitative measure of the coordinated output of the paretic leg and is defined as the percentage of propulsion performed by the paretic leg.
Trial Locations
- Locations (2)
Ralph H. Johnson VA Medical Center, Charleston, SC
🇺🇸Charleston, South Carolina, United States
MUSC Center for Rehabilitation Research in Neurologic Conditions
🇺🇸Charleston, South Carolina, United States