Incline Training to Personalize Motor Control Interventions After Stroke

Not Applicable

Completed

• Conditions: CVA (Cerebrovascular Accident)

• 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.

Study Timeline

• Study First Submitted: 2018-05-23
• Study First Submitted QC: 2018-06-18
• Study First Posted: 2018-06-19
• Study Start: 2018-07-01
• Primary Completion: 2022-05-31
• Results First Submitted: 2023-06-21
• Study Completion: 2023-06-30
• Status Verified: 2024-05
• Results First Submitted QC: 2024-05-20
• Last Update Submitted: 2024-05-20
• Results First Posted: 2024-05-22
• Last Update Posted: 2024-05-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 55

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

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