Recruiting

Vibration

Sponsor:

Shirley Ryan AbilityLab

Code:

NCT03598504

Conditions

Spinal Cord Injuries

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

Interventions

Wearable EMG/Vibration device

Study Details

Brief summary:

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.

Conditions

Spinal Cord Injuries

Study ID

NCT03598504

Start date

Jul 16, 2019

Status verified date

May, 2021

Completion date

Jun 30, 2023

Anticipated

Primary completion date

Dec 15, 2022

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

Inclusion Criteria:

  • Male and females between ages 18-85 years of age
  • SCI ( ≥1 month of injury)
  • ASIA A, B,C and D
  • SCI above L5
  • Able to perform a visible contraction with dorsiflexor and hip flexor muscles (allowing testing of largely impaired patients)
  • Able to ambulate a few steps with or without an assistive device.

Inclusion criteria for healthy controls:

  • Male and females between ages 18-85 years
  • Able to complete precision grips with both hands
  • Able to complete full elbow flexion-extension with both arms.
  • Able to walk and complete lower-limb tests with both legs.

Exclusion Criteria:

  • Uncontrolled medical problems including pulmonary, cardiovascular or orthopedic disease,
  • Any debilitating disease prior to the SCI that caused exercise intolerance
  • Premorbid, ongoing major depression or psychosis, altered cognitive status
  • History of head injury or stroke,
  • Metal plate in skull
  • History of seizures
  • Receiving drugs acting primarily on the central nervous system, which lower the seizure threshold such as antipsychotic drugs (chlorpromazine, clozapine) or tricyclic antidepressants.
  • Pregnant females, and
  • Ongoing cord compression or a syrinx in the spinal cord or who suffer from a spinal cord disease such as spinal stenosis, spina bifida or herniated cervical disk.

This information will be obtained by self-report.

Study Design

Enrollment

198 participants

Anticipated

Allocation

Non randomized

Intervention Model

Crossover

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Healthy Controls Group

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).

active comparator: Spinal Cord Injury Group

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

Interventions

Wearable EMG/Vibration device

The device is a combination of an EMG recorder/detector and a vibrator

Primary outcome measure

  • Changes in muscle spasms with vibration device [ Time Frame: 4 weeks ]

Central Contacts and Locations

Central contacts

Monica Perez, PhD, PT

312-238-2886mperez04@sralab.org

Locations

Shirley Ryan AbilityLab

Recruiting

Chicago, Illinois, United States, 60611

Contacts

Monica A Perez, PhD, PT

312-238-2886mperez04@sralab.org

More Information

Sponsor

Shirley Ryan AbilityLab

Last update posted

May 25, 2021

Last verified

May, 2021

Keywords

  • SCI
  • Spasms
  • Vibration

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Shirley Ryan AbilityLab on 2021-05-25.