Power Training Post-stroke

Completed · Phase 2

Conditions studied: Stroke

In brief

Hemiparesis, strictly defined as (muscular) weakness affecting one side of the body, is seen in three-quarters of individuals following stroke. Weakness in this population results from both neural and muscular factors which include, respectively, the ability to activate skeletal muscle as well as the force generating capacity of the muscle. The overall goal is to improve walking in persons post-stroke by training subjects with an intervention that specifically targets existing neural and muscular impairments, thereby facilitating locomotor recovery.

Key facts

Study ID

NCT01970592

Run by

VA Office of Research and Development

People needed

56

Starts

2013-10-01

Expected to finish

2019-05-31

Last updated by the study team

2020-03-06

Who can join

Age: 50 and older, up to 70. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• age 50-70,
• stroke within the past 6 to 24 months,
• residual paresis in the lower extremity (Fugl-Meyer Lower Extremity motor score <34),
• ability to walk without assistance and without an ankle foot orthotic (AFO) on the treadmill 30 seconds at speeds ranging from 0.3 - 0.8 m/s, and
• provision of informed consent.
• In addition, all subjects who meet criteria for the training portion must complete an exercise tolerance test and be cleared for participation by the study cardiologist.

You may not qualify if…

• Unable to ambulate at least 150 feet prior to stroke, or experienced intermittent claudication while walking;
• rating on Modified Ashworth Scale 3 at the knee or ankle;
• limited lower extremity range of motion of the knee (passive flexion Range of Motion [ROM] < 90); hip (inability to achieve neutral 0 hip extension); or ankle (inability to achieve 0 of active dorsiflexion);
• history of congestive heart failure, unstable cardiac arrhythmias, hypertrophic cardiomyopathy, severe aortic stenosis, angina or dyspnea at rest or during activities of daily living (ADLs);
• History of chronic obstructive pulmonary disease (COPD) or oxygen dependence;
• Preexisting neurological disorders, dementia or previous stroke;
• History of major head trauma;
• Legal blindness or severe visual impairment;
• history of significant psychiatric illness
• Life expectancy <1 yr.,
• Severe arthritis or other problems that limit passive ROM;
• post-stroke depression (PHQ-9 10),
• History of deep vein thrombosis (DVT) or pulmonary embolism within 6 months;
• Uncontrolled diabetes with recent diabetic coma, or frequent insulin reactions;
• Severe hypertension with systolic >200 mmHg and diastolic >110 mmHg at rest;
• Previous or current enrollment in a trial to enhance motor recovery;
• Presence of non-magnetic resonance (MR) compatible implants, pregnancy or severe claustrophobia.

Where it is running

• Ralph H. Johnson VA Medical Center, Charleston, SC — Charleston, South Carolina, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.