Clinical trial NCT04038697: Ischemic Conditioning Improves Walking Function Post Stroke
Official title: Ischemic Conditioning Improves Walking Function Post Stroke
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Stroke
Stroke, Ischemic
Stroke Hemorrhagic
Stroke, Cardiovascular
Keywords: Stroke
Rehabilitation
Ischemic Conditioning
Treadmill Training
Lead sponsor: Medical College of Wisconsin
Sponsor class: OTHER
Collaborators: name: Marquette University
First posted: 2019-07-31
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This innovative study will address scientific and clinical areas relatively unexplored in chronic stroke that could lead to greater recovery of walking. Ischemic Conditioning (IC) is a non-invasive, simple procedure that improves motor function, exercise performance and cardiovascular function in healthy controls, but it has never been applied to the stroke population. We postulate that IC enhances the recruitment of motoneurons and results in positive neural adaptations, improves vascular endothelial function and peripheral blood flow, and together these improvements result in an increased capacity to exercise and faster walking speed. Future studies will examine the effects of IC and traditional therapy at different time points of recovery post stroke, durability of IC, molecular mechanisms of neural and cardiovascular adaptation and the efficacy compared with other adjuncts.

Detailed description: This study will quantify the effects of Ischemic Conditioning and treadmill training on improvements in: walking speed, leg strength, neuromuscular fatigability and the hyperemic blood flow response to muscle contractions, and vascular endothelial function and aerobic exercise capacity. A randomized control design will be used with three groups of chronic stroke survivors enrolled for four weeks of training (3x/week; 12 sessions total). The groups are: IC + Treadmill Training, IC Sham + Treadmill Training, and IC only. We will also enroll a group of age- and sex-matched healthy control subjects who will undergo IC + Treadmill Training. All Aims will be tested concurrently over a five-year period. All studies will be performed in Cramer Hall at Marquette University in the Integrated Neural Engineering Rehabilitation Laboratories, the Human Performance Assessment Core, and the Physical Therapy Clinic.

Randomization of stroke patients to the three intervention groups will be performed by using randomized block designs (randomly chosen block sizes of 3, 6 and 9). This number accounts for possible dropouts and the use of non- parametric methods.

Eligibility criteria: Inclusion Criteria (Stroke Survivors):

1. be ≥ 1 year post diagnosis of a unilateral, cortical stroke and have residual lower extremity paresis
2. be between the ages of 18-85
3. be able to give informed consent
4. walk slower than normative values based on age and sex

Exclusion Criteria (Stroke Survivors):

1. history of deep vein thrombosis or any condition in which transient ischemia to the lower extremity is contraindicated
2. inability to follow 2 step commands
3. chronic low back or hip pain
4. history of substance abuse
5. history of head trauma
6. comorbid neurological disorder
7. any uncontrolled medical condition
8. pacemaker
9. any condition where fatiguing contractions or resisted leg contractions are contraindicated
10. inability to walk for 5 minute bouts on a treadmill with a harness supporting up to 50% of the body weight at 80% of over-ground self-selected walking speed.

Inclusion Criteria (Healthy Control Subjects):

1. be between ages of 18-85
2. be able to give informed consent

Exclusion Criteria (Healthy Control Subjects):

1. Those listed above for stroke survivors
2. History of Stroke

Primary outcomes:
measure: Self Selected Walking Speed
timeFrame: Change from baseline to 4 weeks.
Secondary outcomes:
measure: Knee Extensor Leg Strength
timeFrame: Change from baseline to 4 weeks.
measure: Knee Extensor Fatigability
timeFrame: Change from baseline to 4 weeks.
measure: Flow Mediated Dilation of Non-Paretic Brachial Artery and Paretic Popliteal Artery
timeFrame: Change from baseline to 4 weeks.
measure: Peak Oxygen Consumption
timeFrame: Change from baseline to 4 weeks.
Other outcomes:
measure: Six minute walk test
timeFrame: Change from baseline to 4 weeks.
measure: Lower Extremity Fugl Meyer
timeFrame: Change from baseline to 4 weeks.
measure: Manual Muscle Test
timeFrame: Change from baseline to 4 weeks.
measure: Modified Ashworth Scale
timeFrame: Change from baseline to 4 weeks.
measure: Bipolar Surface Electromyography (EMG) Measurements
timeFrame: Change from baseline to 4 weeks.
measure: Voluntary Activation of Paretic Muscle
timeFrame: Change from baseline to 4 weeks.
measure: Surface EMG Motor Unit Measurements
timeFrame: Change from baseline to 4 weeks.
measure: Hyperemic Blood Flow in Response to Muscle Contractions
timeFrame: Change from baseline to 4 weeks.
measure: Heart Rate Variability (HRV)
timeFrame: Change from baseline to 4 weeks.
measure: Step Cadence
timeFrame: Change from baseline to 4 weeks.
measure: Step Length
timeFrame: Change from baseline to 4 weeks.
measure: Step Velocity
timeFrame: Change from baseline to 4 weeks.
measure: Ground Reaction Force
timeFrame: Change from baseline to 4 weeks.
measure: Ankle, Hip and Knee Joint Trajectories
timeFrame: Change from baseline to 4 weeks.
Locations:
city: Milwaukee
country: United States
facility: Medical College of Wisconsin
state: Wisconsin
city: Milwaukee
country: United States
facility: Marquette University
state: Wisconsin
Study officials:
References: