Incline Training to Personalize Motor Control Interventions After Stroke

CVA (Cerebrovascular Accident) Clinical Trial

Official title:

Incline Training to Personalize Motor Control Interventions After Stroke

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03561246
• Other study ID #: N2665-R
• Secondary ID: 77797
• Status: Active, not recruiting
• Phase: N/A
• Start date: July 1, 2018
• Est. completion date: June 30, 2023

Study information

• Verified date: July 2022
• Source: VA Office of Research and Development
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Active, not recruiting
• Enrollment: 55
• Est. completion date: June 30, 2023
• Est. primary completion date: May 31, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 25 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• CVA (Cerebrovascular Accident)
• Stroke

Intervention

Other:
• Incline treadmill walking
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.
• Decline treadmill walking
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.

Locations

Country	Name	City	State
United States	MUSC Center for Rehabilitation Research in Neurologic Conditions	Charleston	South Carolina
United States	Ralph H. Johnson VA Medical Center, Charleston, SC	Charleston	South Carolina

Sponsors (1)

Lead Sponsor	Collaborator
VA Office of Research and Development

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.