Incline Training to Personalize Motor Control Interventions After Stroke

VA Office of Research and Development

Status: Completed

Conditions: CVA (Cerebrovascular Accident)

Treatments: Other: Decline treadmill walking; Other: Incline treadmill walking; Other: Level Treadmill (Control)

Study type: Interventional

Funder types: Other U.S. Federal agency

Identifiers

NCT03561246

N2665-R

77797 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 55 patients

Sex: All

Ages: 25 to 75 years old

Volunteers: Accepts Healthy Volunteers

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)
• 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
• 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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55 participants in 3 patient groups

Personalized training effect on SSWS and Pp - Incline

Active Comparator group

Description:

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.

Treatment:

Other: Incline treadmill walking

Personalized training effect on SSWS and Pp - Decline

Active Comparator group

Description:

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.

Treatment:

Other: Decline treadmill walking

Personalized training effect on SSWS and Pp - Level treadmill (Control)

Active Comparator group

Description:

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.

Treatment:

Other: Level Treadmill (Control)