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Completed

NCT Number: NCT03561246

Incline Training to Personalize Motor Control Interventions After Stroke

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.

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Key information

Age range

25 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

MUSC Center for Rehabilitation Research in Neurologic Conditions, Charleston, South Carolina, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

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.

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.

Primary outcomes

  1. Change in Gait Speed

    Time frame: 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 outcomes

  1. Change in Paretic Propulsion Symmetry

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

VA Office of Research and Development

Fed

Registry information

Important dates

Study start
2018
Primary completion
2022
Study completion
2023
First posted
Jun 19, 2018
Registry last updated
May 22, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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