Recruitment

Recruitment Status
Recruiting
Estimated Enrollment
Same as current

Summary

Conditions
Spinal Cord Injuries
Type
Interventional
Phase
Not Applicable
Design
Allocation: Non-RandomizedIntervention Model: Crossover AssignmentMasking: Single (Outcomes Assessor)Masking Description: Clinical measures of spasticity before, during, and after the intervention will be implemented by an evaluator blind to the treatment effectsPrimary Purpose: Treatment

Participation Requirements

Age
Between 18 years and 85 years
Gender
Both males and females

Description

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. b) Determine the vibration parameters that best reduce spasms in leg muscles paralyzed by spinal ...

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. 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. 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.

Tracking Information

NCT #
NCT03598504
Collaborators
National Institute of Neurological Disorders and Stroke (NINDS)
Investigators
Principal Investigator: Monica Perez, PhD, PT Shirley Ryan AbilityLab