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. 1. b) Determine the vibration parameters that best reduce spasms in leg muscles paralyzed by spinal cord injury (SCI) in the laboratory using the wearable device. 2. a) Examine the efficacy of tendon vibration in altering muscle spasms by treating spasms as they occur in real world environments using 24-hour electromyographic (EMG) recordings. 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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
198
The device is a combination of an EMG recorder/detector and a vibrator
Shirley Ryan AbilityLab
Chicago, Illinois, United States
RECRUITINGChanges in muscle spasms with vibration device
Measured by records of EMG from 4 muscles to quantify spasms
Time frame: 4 weeks
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.
Time frame: 10 minutes
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