Clinical trial NCT03561246: Incline Training to Personalize Motor Control Interventions After Stroke
Official title: Incline Training to Personalize Motor Control Interventions After Stroke
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: CVA (Cerebrovascular Accident)
Keywords: Stroke
Rehabilitation
Walking
Biomechanics
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
First posted: 2018-06-19
Enrollment: 55
Sex: ALL
Minimum age (years): 25
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change in Gait Speed
timeFrame: Pre (same day but prior to initial training session) and post (immediately following final training session) approximately 4 weeks apart.
Secondary outcomes:
measure: Change in Paretic Propulsion Symmetry
timeFrame: Pre (same day but prior to initial training session) and post (immediately following final training session) approximately 4 weeks apart.
Other outcomes:
Locations:
city: Charleston
country: United States
facility: Ralph H. Johnson VA Medical Center, Charleston, SC
state: South Carolina
city: Charleston
country: United States
facility: MUSC Center for Rehabilitation Research in Neurologic Conditions
state: South Carolina
Study officials:
affiliation: Ralph H. Johnson VA Medical Center, Charleston, SC
name: Brian Cence
role: PRINCIPAL_INVESTIGATOR
References: