Incline Training to Personalize Motor Control Interventions After Stroke

Study Overview
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Brief Summary
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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
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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.

Official Title
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Incline Training to Personalize Motor Control Interventions After Stroke

Conditions
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CVA (Cerebrovascular Accident)

Intervention / Treatment
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* Other: Incline treadmill walking
* Other: Decline treadmill walking


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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) Pp between 0.47 and 0.53 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). Exclusion Criteria: 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 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.

Ages Eligible for Study
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Minimum Age: 25 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Personalized training effect on SSWS<br>Determine the efficacy of motor control deficit guided personalized training on SSWS compared to non-personalized and CONTROL interventions. Incline treadmill walking Decline treadmill walking | Other: Incline treadmill walking<br>* Those with a Pp 0.47 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.<br>Other: Decline treadmill walking<br>* Those with a Pp 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.<br>|
| Active Comparator: Personalized training effect on Pp<br>Determine the efficacy of motor control deficit guided personalized training on increasing symmetry of Pp compared to non-personalized and CONTROL interventions. Incline treadmill walking Decline treadmill walking | Other: Incline treadmill walking<br>* Those with a Pp 0.47 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.<br>Other: Decline treadmill walking<br>* Those with a Pp 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.<br>|
| Active Comparator: Positive response<br>Determine if the personalized intervention increase the positive response rate compared to non-personalized and CONTROL interventions, and to further advance personalize interventions by identifying factors that predict response. Incline treadmill walking Decline treadmill walking | Other: Incline treadmill walking<br>* Those with a Pp 0.47 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.<br>Other: Decline treadmill walking<br>* Those with a Pp 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Gait Speed | 10 Meter Walk Test | Pre (same day but prior to initial training session) and post (immediately following final training session) approximately 4 weeks apart, and follow-up at 1 month after the last training session. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Paretic Propulsion Symmetry | Quantitative measure of the coordinated output of the paretic leg and is defined as the percentage of propulsion performed by the paretic leg. | Pre (same day but prior to initial training session) and post (immediately following final training session) approximately 4 weeks apart, and follow-up at 1 month after the last training session. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Stroke, Rehabilitation, Walking, Biomechanics