Rehabilitating Corticospinal Control of Walking

Completed · Not applicable

Conditions studied: Stroke

In brief

The VHA estimates that over 15,000 Veterans incur a stroke each year. As the population of older Veterans grows, stroke will become an increasingly important problem to the VHA. Recovery of walking function is the most common goal of stroke survivors. The proposed study will test whether training with accurate walking tasks to engage the damaged supraspinal motor pathways is more effective than training with steady state walking. The investigators expect that training accurate tasks will be more effective, thereby improving walking function of Veteran stroke survivors and reducing the burden of care placed on families and on the VHA. Furthermore, this rehabilitation approach can be accomplished at comparable cost to existing rehabilitation approaches, which is important given that the VHA invests $88 million per year toward outpatient care, including physical rehabilitation, in the first six months after stroke. This research also has implications for rehabilitation of other neurologically injured populations, including traumatic brain injury and incomplete spinal cord injury.

Key facts

Study ID

NCT02132650

Run by

VA Office of Research and Development

People needed

38

Starts

2014-06-02

Expected to finish

2019-05-31

Last updated by the study team

2022-05-05

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• occurrence of a single unilateral stroke within the previous 6-18 months (verified by MRI or CT from medical record)
• living in the community and able to travel to training and assessment sites
• approval of participation by primary care physician
• age 18 - 80 years
• lower extremity paresis indicated by Fugl-Meyer Assessment Score < 30
• deficit in at least one "synergy" subcategory (II - IV) of the Fugl-Meyer Assessment
• self-selected 10m gait speed of 0.4 - 0.8 m/s (with or without an ankle/foot orthosis or cane)
• able to provide informed consent
• willingness to be randomized to either intervention group
• written approval by primary care physician

You may not qualify if…

• neurological disorder or injury (other than stroke) such as Parkinson' s disease or spinal cord injury
• severe arthritis, such as awaiting joint replacement, that would interfere with study participation
• cardiovascular disease (congestive heart failure, significant valvular disease, history of cardiac arrest, presence of an implantable defibrillator, uncontrolled angina)
• myocardial infarction or major heart surgery in the previous year
• cancer requiring treatment in the past three years, except for nonmelanoma skin cancers and other cancers having an excellent prognosis (e.g., early stage breast or prostate cancer)
• lung disease requiring use of corticosteroids or supplemental oxygen
• renal disease requiring dialysis
• current diagnosis of schizophrenia, other psychotic disorders, or bipolar disorder
• Mini-Mental State Examination (MMSE) score <23
• major depression (Patient Health Questionnaire score > 10)
• severe obesity (body mass index > 35)
• uncontrolled hypertension (systolic > 200 mmHg and/or diastolic > 110 mmHg)
• uncontrolled diabetes with recent diabetic coma or frequent hypoglycemia
• bone fracture or joint replacement in the previous six months
• diagnosis of a terminal illness
• current participation in physical therapy or cardiopulmonary rehabilitation
• significant visual impairment affecting capability to gauge movement accuracy
• previous enrollment in a clinical trial for recovery of walking function
• current enrollment in any clinical trial
• planning to relocate out of the greater Gainesville FL area during the study period
• unable to communicate sufficiently with study personnel
• clinical judgment regarding safety or noncompliance

Where it is running

• North Florida/South Georgia Veterans Health System, Gainesville, FL — Gainesville, Florida, United States
• Brooks Rehabilitation Hospital — Jacksonville, Florida, United States

Full record on ClinicalTrials.gov

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