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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03561246
Other study ID # N2665-R
Secondary ID 77797
Status Completed
Phase N/A
First received
Last updated
Start date July 1, 2018
Est. completion date June 30, 2023

Study information

Verified date May 2024
Source VA Office of Research and Development
Contact n/a
Is FDA regulated No
Health authority
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 Completed
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) - 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


Related Conditions & MeSH terms


Intervention

Other:
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.
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.
Level Treadmill (Control)
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.

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 Participants will be asked to complete a 10 Meter Walk Test and a difference will be calculated between pre and post speed. Pre (same day but prior to initial training session) and post (immediately following final training session) approximately 4 weeks apart.
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.
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