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| ID | Type | Description | Link |
|---|---|---|---|
| 1R01NS100810-01A1 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Neurological Disorders and Stroke (NINDS) | NIH |
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This study uses closed-loop control of tendon vibration to implement clinically meaningful management of muscle spasms after spinal cord injury (SCI), and to understand the mechanisms responsible for spasm generation change in response to vibration.
The specific aims of this study are listed below:
1a) Evaluate the ergonomics of the wearable device that will be used to record and detect spasms, then to deliver vibration to tendons to dampen spasms.
Hypothesis 2a: Achilles tendon vibration will dampen spasms acutely, and may alter their distribution Assess excitatory and/or inhibitory mechanisms that underlie spasms, and changes induced with vibration, by recording physiological, clinical, functional and self-reported measures of different aspects of spasticity, and health-related quality of life, before and after conditioning spasms with vibration. These data will provide insight into the site(s), magnitude, and time-course of changes with vibration; and user perspective on the effects of the therapy.
Achilles tendon vibration will dampen spasms by reconfiguring circuits generating 6-13 Hz shared drive to motoneurons.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Healthy Controls Group | Active Comparator | 1. A focus group to gather information about the perceptions, opinions, beliefs, and attitudes towards management of muscle spasms by vibration using our portable device, information that will drive design improvement (size, fit, weight). |
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| Spinal Cord Injury Group | Active Comparator | 1a. A focus group to gather information about the perceptions, opinions, beliefs, and attitudes towards management of muscle spasms by vibration using our portable device, information that will drive design improvement (size, fit, weight). 1b. In the lab, we will trigger spasms in paralyzed leg muscles in one of two common postures (seated, reclined), detect the contractions using electromyography (EMG), and condition alternate spasms with vibration using our custom device. We will examine the vibration parameters that reduce muscle spasms best. 2. Participants will complete 1 or 2 multi-day experiments. EMG (24-hour) data will be collected at baseline (day 1), during the vibration intervention (day 2), and post intervention (day 3) to examine the acute effects of vibration on muscle spasms |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Wearable EMG/Vibration device | Device | The device is a combination of an EMG recorder/detector and a vibrator |
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| Measure | Description | Time Frame |
|---|---|---|
| Changes in muscle spasms with vibration device | Measured by records of EMG from 4 muscles to quantify spasms | 4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Questionnaire | Quantitative and qualitative survey for subjects developed to evaluate comfort and user-friendliness of device. The questionnaire includes 11-point scale questions to rate spasms and effect of the device (0 means no effect and 10 means complete satisfaction. Values for each answer will be interpreted separately and a 10 signifies a better outcome); dichotomous (yes/no) questions about the device, where "no" signifies no interruption to their different routines and therefore "no" represents a better outcome; and free-answer questions to collect qualitative data on concerns and recommendations. |
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Inclusion Criteria:
Inclusion criteria for healthy controls:
Exclusion Criteria:
This information will be obtained by self-report.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Monica Perez, PhD, PT | Contact | 312-238-2886 | mperez04@sralab.org |
| Name | Affiliation | Role |
|---|---|---|
| Monica Perez, PhD, PT | Shirley Ryan AbilityLab | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shirley Ryan AbilityLab | Recruiting | Chicago | Illinois | 60611 | United States |
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| ID | Term |
|---|---|
| D013119 | Spinal Cord Injuries |
| D013035 | Spasm |
| ID | Term |
|---|---|
| D013118 | Spinal Cord Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D020196 | Trauma, Nervous System |
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Clinical measures of spasticity before, during, and after the intervention will be implemented by an evaluator blind to the treatment effects
| 10 minutes |
| D014947 | Wounds and Injuries |
| D020879 | Neuromuscular Manifestations |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |