Incline Training to Personalize Motor Control Interventions After Stroke

NCT03561246 | Completed Results DMC

• 2 other identifiers: N2665-R77797
• Study Type: interventional
• Target: 55
• Locations: 1 country
• Sites: 2

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.

Conditions

CVA (Cerebrovascular Accident)

Keywords

Stroke; Rehabilitation; Walking; Biomechanics

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• 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.

Study Arms (3)

Personalized training effect on SSWS and Pp - Incline

ACTIVE COMPARATOR

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.

Other: Incline treadmill walking

Personalized training effect on SSWS and Pp - Decline

ACTIVE COMPARATOR

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.

Other: Decline treadmill walking

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

ACTIVE COMPARATOR

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.

Other: Level Treadmill (Control)

Interventions

Incline treadmill walking 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 - Incline

Decline treadmill walking 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 - Decline

Level Treadmill (Control) 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.

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

Eligibility Criteria

• Age: 25 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• VA Office of Research and Development: lead

Study Sites (2)

Ralph H. Johnson VA Medical Center, Charleston, SC

Charleston, South Carolina, 29401-5799, United States

Location

MUSC Center for Rehabilitation Research in Neurologic Conditions

Charleston, South Carolina, 29425, United States

Location

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Limitations and Caveats

We did not reach our target number of 60 participants due to the COVID-19 pandemic. The formatting of our study at its conclusion is different than its original presentation. Our 'arms' are updated as the incline, decline, and level treadmill conditions. We present gait speed and Pp outcomes across three conditions in our final report. We caution interpretation due to the potential impact of paretic propulsion baseline characteristic on the response to incline or decline walking conditions.

Results Point of Contact

• Title: Mark G. Bowden - PI
• Organization: Brooks Rehabilitation Clinical Research Center

mark.bowden@brooksrehab.org

904-345-6626

Study Officials

• Brian Cence

  Ralph H. Johnson VA Medical Center, Charleston, SC

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 23, 2018
• First Posted: June 19, 2018
• Study Start: July 1, 2018
• Primary Completion: May 31, 2022
• Study Completion: June 30, 2023
• Last Updated: May 22, 2024
• Results First Posted: May 22, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Completion of all study Aims. De-identified data set will be available for other investigators and registered in the NIH-supported registry.

Locations

US (2)