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The goal of this clinical trial is to learn if operant conditioning can reduce spasticity in order to improve walking in stroke patient. The main questions it aims to answer are:
Researchers will compare result to able bodied participants to see if [insert effects]
The study purpose is to investigate the possibility and later effect of spinal reflex self-regulation in post-stroke stiff-knee gait. The intervention will consist of direct current surface stimulation of the peripheral nerves using electrical stimulation. Stimulation will evoke a motor response that will be collected through surface EMG electrodes and processed to depict a measure of the response as feedback to the participant to complete the loop of operant conditioning. The participant will attempt to modulate their responses over multiple sessions to cause this depiction to either increase or decrease its value depending on an established target.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental: Post-stroke Stiff-Knee Gait Participants | Experimental | Individuals with post-stroke Stiff-Knee gait |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Peripheral Nerve Stimulation | Device | Electrical stimulation of peripheral nerves to measure resulting gait kinematics and surface muscle activity |
|
| Measure | Description | Time Frame |
|---|---|---|
| Surface electromyographic recording of leg muscles | Recording electrical activity of leg muscles during walking in response to peripheral nerve stimulation | baseline, week 6 -mid-treatment, week 12 - end of treatment, 4-week post treatment, 12 weeks post treatment, 24 weeks post treatment |
| Measure | Description | Time Frame |
|---|---|---|
| 10 meter walk test | 10 meter walk test with collection of gait kinematics captured using an inertial motion capture camera system | baseline, week 6 -mid-treatment, week 12 - end of treatment, 4-week post treatment, 12 weeks post treatment, 24 weeks post treatment |
| quadriceps pendulum test |
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Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| James Sulzer, PhD | MetroHealth Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| MetroHealth Medical Center | Cleveland | Ohio | 44109 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26371855 | Background | Burpee JL, Lewek MD. Biomechanical gait characteristics of naturally occurring unsuccessful foot clearance during swing in individuals with chronic stroke. Clin Biomech (Bristol). 2015 Dec;30(10):1102-7. doi: 10.1016/j.clinbiomech.2015.08.018. Epub 2015 Sep 2. | |
| 32843057 | Background | Akbas T, Kim K, Doyle K, Manella K, Lee R, Spicer P, Knikou M, Sulzer J. Rectus femoris hyperreflexia contributes to Stiff-Knee gait after stroke. J Neuroeng Rehabil. 2020 Aug 26;17(1):117. doi: 10.1186/s12984-020-00724-z. |
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| ID | Term |
|---|---|
| D020521 | Stroke |
| D020233 | Gait Disorders, Neurologic |
| D051346 | Mobility Limitation |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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This is a method of evaluating spasticity using gravity to provoke the muscular stretch reflex allowing for the collection of joint angle data. This data will aid in assessing changes in joint angles as a result of training. |
| baseline, week 6 -mid-treatment, week 12 - end of treatment, 4-week post treatment, 12 weeks post treatment, 24 weeks post treatment |
| Five Times Sit to Stand Test | measures lower extremity functional strength. This test will measure your leg strength by asking you to sit down and stand up from a chair 5 times as fast as possible. | baseline, week 6 -mid-treatment, week 12 - end of treatment, 4-week post treatment, 12 weeks post treatment, 24 weeks post treatment |
| Transcranial Magnetic Stimulation (TMS) | non-invasive brain stimulation device, will be used to elicit a motor evoked response in participants via low frequency stimulation to the cortical regions associated with the muscles being investigated. This approach will test the integrity of the participant's CST in relation to the intervention and assessments being conducted | Baseline, Week 12 - end of treatment |
| 25914638 | Background | Li S, Francisco GE. New insights into the pathophysiology of post-stroke spasticity. Front Hum Neurosci. 2015 Apr 10;9:192. doi: 10.3389/fnhum.2015.00192. eCollection 2015. |
| 30127749 | Background | Li S, Francisco GE, Zhou P. Post-stroke Hemiplegic Gait: New Perspective and Insights. Front Physiol. 2018 Aug 2;9:1021. doi: 10.3389/fphys.2018.01021. eCollection 2018. |
| 18164331 | Background | Stoquart GG, Detrembleur C, Palumbo S, Deltombe T, Lejeune TM. Effect of botulinum toxin injection in the rectus femoris on stiff-knee gait in people with stroke: a prospective observational study. Arch Phys Med Rehabil. 2008 Jan;89(1):56-61. doi: 10.1016/j.apmr.2007.08.131. |
| 34692437 | Background | Dehnadi Moghadam A, Hasanzadeh H, Dehnadi Moghadam F. Evaluation of the Effect of Intranasal Lidocaine in the Treatment of Spasticity in Patients with Traumatic Brain Injury. Anesth Pain Med. 2021 Aug 15;11(4):e115849. doi: 10.5812/aapm.115849. eCollection 2021 Aug. |
| 26321489 | Background | Navarrete-Opazo AA, Gonzalez W, Nahuelhual P. Effectiveness of Oral Baclofen in the Treatment of Spasticity in Children and Adolescents With Cerebral Palsy. Arch Phys Med Rehabil. 2016 Apr;97(4):604-618. doi: 10.1016/j.apmr.2015.08.417. Epub 2015 Aug 28. |
| 6663327 | Background | Wolpaw JR, Braitman DJ, Seegal RF. Adaptive plasticity in primate spinal stretch reflex: initial development. J Neurophysiol. 1983 Dec;50(6):1296-311. doi: 10.1152/jn.1983.50.6.1296. |
| 3480233 | Background | Wolpaw JR, Lee CL. Motoneuron response to dorsal root stimulation in anesthetized monkeys after spinal cord transection. Exp Brain Res. 1987;68(2):428-33. doi: 10.1007/BF00248809. |
| 7714584 | Background | Chen XY, Wolpaw JR. Operant conditioning of H-reflex in freely moving rats. J Neurophysiol. 1995 Jan;73(1):411-5. doi: 10.1152/jn.1995.73.1.411. |
| 19420246 | Background | Thompson AK, Chen XY, Wolpaw JR. Acquisition of a simple motor skill: task-dependent adaptation plus long-term change in the human soleus H-reflex. J Neurosci. 2009 May 6;29(18):5784-92. doi: 10.1523/JNEUROSCI.4326-08.2009. |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |