Incline Training to Personalize Motor Control Interventions After Stroke

NCT ID: NCT03561246

Last Updated: 2024-05-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 55 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-07-01
• Study Completion Date: 2023-06-30

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.

Conditions

CVA (Cerebrovascular Accident)

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Personalized training effect on SSWS and Pp - Incline

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.

Group Type: ACTIVE_COMPARATOR

Incline treadmill walking

Intervention Type: OTHER

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.

Personalized training effect on SSWS and Pp - Decline

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.

Group Type: ACTIVE_COMPARATOR

Decline treadmill walking

Intervention Type: OTHER

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.

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

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.

Group Type: ACTIVE_COMPARATOR

Level Treadmill (Control)

Intervention Type: OTHER

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.

Interventions

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.

Intervention Type: OTHER

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.

Intervention Type: OTHER

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.

Intervention Type: OTHER

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.

• Minimum Eligible Age: 25 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

VA Office of Research and Development

FED

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Brian Cence

Role: PRINCIPAL_INVESTIGATOR

Ralph H. Johnson VA Medical Center, Charleston, SC

Locations

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

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

77797

Identifier Type: OTHER

Identifier Source: secondary_id

N2665-R

Identifier Type: -

Identifier Source: org_study_id