NCT07006818 · University of Illinois at Chicago
Impaired Interlimb Coordination During Locomotion in Individuals With Chronic Stroke: Contributors and Effect on Walking Function
What this study is about
Individuals with chronic stroke have long-term walking problems that limit community engagement and quality of life, lead to secondary disabilities, and increase healthcare costs and burden. These walking issues often persist despite rehabilitation. One novel target for stroke gait rehabilitation is interlimb coordination-the phase-dependent cyclical relation of the legs.
View original scientific description
Individuals with chronic stroke have long-term walking problems that limit community engagement and quality of life, lead to secondary disabilities, and increase healthcare costs and burden. These walking issues often persist despite rehabilitation. One novel target for stroke gait rehabilitation is interlimb coordination-the phase-dependent cyclical relation of the legs. Interlimb coordination is altered during walking after stroke, compromising walking stability, phase transitions, and responses to perturbation and contributing to motor compensation. It is unclear what neural pathways contribute to impaired interlimb coordination after stroke and what impact this has on walking-related outcomes. This proposal consists of two aims to address these issues, with the long-term goal of developing therapeutic interventions to improve interlimb coordination and walking after stroke. Aim 1 will identify which neural sources contribute to impaired interlimb coordination after stroke. During bilateral, cyclical recumbent stepping (analogue of walking), interlimb coordination will be assessed as relative leg phasing. During the task, transcranial magnetic stimulation and peripheral nerve stimulation will be applied to assess supraspinal, interhemispheric, spinal interneuronal, and sensory pathways. The relation of interlimb coordination with these outcomes will be assessed to determine potential contributors. Aim 2 will test the association between interlimb coordination and walking after stroke. Interlimb coordination will be quantified during split-belt treadmill walking, and associations with walking speed, endurance, mobility, independence, daily activity, quality of life, and community engagement will be tested. An additional exploratory aim will determine the effect of targeted neuromodulation on lower limb interlimb coordination. Electrical stimulation will be applied to three locations in a cross-over study: the primary motor cortex (supraspinal/interhemispheric), thoracolumbar spine (spinal interneuronal), and peripheral nerves (sensory).
Interventions
DEVICE
Direct current stimulation
Direct current stimulation will be applied at 2 mA for 20 minutes.
Primary outcome measures
Corticomotor excitability
Time frame: immediately before and after immediately after the intervention
Transcranial magnetic stimulation (TMS) will be used to measure change in contralateral and ipsilateral corticomotor excitability of the paretic tibialis anterior, medial gastrocnemius, rectus femoris, and biceps femoris. TMS will be applied at different intensities, and the response (motor evoked potential) is measured in the paretic TMS. Corticomotor excitability will be measured as the slope of the input output curve (intensity vs. response). Higher values represent greater corticomotor excitability.
Cutaneous reflexes
Time frame: immediately before and after immediately after the intervention
A train of 5 short duration (1 ms) electrical pulses at \~300 Hz will be applied to the cutaneous superficial peroneal nerve. These pulses elicit reflex responses in muscles throughout the leg (cutaneous reflexes). Amplitude of muscle activation during stimulation will be compared to periods without stimulation.
H-reflexes
Time frame: immediately before and after immediately after the intervention
1ms electrical pulses will be applied to the deep fibular (peroneal) nerve. Two evoked potentials (M-wave and H-reflex) in the muscle that will be recorded with electromyography (EMG). Stimulations will be applied at a variety of intensities ranging from 70% of H-reflex threshold up to 120% of M-Max. M and H input-output curves will be generated. We will extract the maximal H-reflex response at any intensity (H-max), calculate the H-max/M-max ratio, and determine the slope of the ascending portion of the H-reflex curve (determined with a sigmoidal function).
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Age: 25 - 90 years of age
- Monohemispheric stroke
- Chronic phase (\> 6 months post stroke)
- Ability to walk for at least 6 minutes at a self-selected comfortable speed
Exclusion criteria
- Lesions affecting the brainstem or cerebellum
- Other neurological disorders
- Current botox treatments for the lower limb
- Significant cognitive or communication impairment TMS exclusion criteria
- Previous adverse reaction to TMS
- Skull abnormalities or fractures
- Concussion within the prior 6 months
- Unexplained, recurring headaches
- Implanted cardiac pacemaker
- Metal implants in the head or face
- History of seizures or epilepsy
- Use of medications that could increase risk of seizure
- Current pregnancy PNS \& DCS exclusion criteria
- Skin hypersensitivity at any sites of stimulation, including the scalp, thoracolumbar spine, and peripheral limbs
- History of contact dermatitis at any of the sites of stimulation
- History of allodynia and/or hyperalgesia
- Active skin infection
- Skin lesions
- Deep vein thrombosis
- Any other skin or scalp condition that could be aggravated by stimulation
- Implanted electronic, metallic, or highly conductive devices near site of stimulation that cannot be removed without permission from a health professional
Where
- Chicago, Illinois
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Dec 5, 2025 · Source of record for eligibility and locations