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Vibration

Whole Body Vibration for Spinal Cord Injury

N/A
Waitlist Available
Led By Trevor A. Dyson-Hudson, M.D.
Research Sponsored by Kessler Foundation
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
The subject has self reported spasticity that negatively impacts his or her quality of life, impairs ability to perform activities of daily living (such as transfers, sitting, sleep, wheelchair use, and hobbies).
The subject is able to stand with the assistance of a tilt table at a minimum of 70 degrees for 45 minutes without significant orthostasis or other adverse events or symptoms.
Must not have
The subject experiences pain that is not well controlled with consistent pain medication use.
The subject has recent thromboembolism, diabetes mellitus, intractable hypertension or cardiac/pulmonary instability, internal fixation implants, acute thrombosis, pregnancy, acute inflammation of the locomotor system including active arthrosis or arthropathy, acute tendinopathy, acute hernia, acute discopathy, recent post-surgical wounds, epilepsy, rheumatoid arthritis, or recent fractures<6 months.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up participants will be followed for the duration of the 3 treatments, an expected average of 1 week
Awards & highlights

Summary

This trial is testing whether whole-body vibration while standing on a tilt table can improve spasticity in people with spinal cord injuries. Spasticity will be monitored before and after the intervention.

Who is the study for?
This trial is for adults aged 18-70 with spinal cord injuries above T10, who've had stable moderate to severe spasticity for at least six months. They should be able to stand on a tilt table and follow the study protocol. Excluded are those with conditions that could affect results or have uncontrolled pain, skin breakdown where pressure is applied during standing, recent fractures, or certain medical conditions.Check my eligibility
What is being tested?
The study tests if whole body vibration while standing on a tilt table can reduce muscle spasms in people with spinal cord injury. Participants will undergo three sessions of vibration therapy across separate days and their spasticity levels will be measured before and after treatment using specific scales.See study design
What are the potential side effects?
Potential side effects may include discomfort from the vibrations or standing position, orthostatic symptoms (like dizziness when upright), and possibly skin irritation where the body contacts the tilt table.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I experience muscle stiffness that affects my daily life and activities.
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I can stand with help at a steep angle for 45 minutes without feeling faint or unwell.
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My spinal cord injury is above my waist.
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I am between 18 and 70 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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My pain is not well managed despite taking pain medication regularly.
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I do not have recent severe health issues like heart problems, uncontrolled diabetes, or recent surgery.
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I do not have muscle stiffness affecting my daily life.
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I have spinal hardware or artificial joints in my legs.
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I have skin damage in areas that are pressed on when I stand on a tilt table.
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I am experiencing symptoms like fever, chills, or pain when urinating.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~participants will be followed for the duration of the 3 treatments, an expected average of 1 week
This trial's timeline: 3 weeks for screening, Varies for treatment, and participants will be followed for the duration of the 3 treatments, an expected average of 1 week for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change from Baseline in the Spinal Cord Injury Spasticity Evaluation Tool (SCI-SET) score after the third treatment
Secondary outcome measures
Change from Baseline in the Pain Severity Numerical Rating Scale (NRS) score after the third treatment
Change from Baseline in the Penn Spasm Frequency Scale score after the third treatment
Other outcome measures
Adverse Events
Subject Global Impression of Change (SGIC)

Trial Design

1Treatment groups
Experimental Treatment
Group I: Vibration with tilt-table standingExperimental Treatment1 Intervention
Participants in this arm will undergo alternating side-to-side, whole body vibration while standing on a tilt table for multiple treatments for a total of approximately 14 minutes for 3 sessions over 3 different days

Find a Location

Who is running the clinical trial?

Kessler FoundationLead Sponsor
175 Previous Clinical Trials
10,718 Total Patients Enrolled
Trevor A. Dyson-Hudson, M.D.Principal InvestigatorKessler Foundation
5 Previous Clinical Trials
225 Total Patients Enrolled
Steven C. Kirshblum, M.D.Principal InvestigatorKessler Institute for Rehabilitation
2 Previous Clinical Trials
89 Total Patients Enrolled

Media Library

Whole Body Vibration (Vibration) Clinical Trial Eligibility Overview. Trial Name: NCT02127606 — N/A
Spinal Cord Injury Research Study Groups: Vibration with tilt-table standing
Spinal Cord Injury Clinical Trial 2023: Whole Body Vibration Highlights & Side Effects. Trial Name: NCT02127606 — N/A
Whole Body Vibration (Vibration) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02127606 — N/A
Spinal Cord Injury Patient Testimony for trial: Trial Name: NCT02127606 — N/A
~4 spots leftby Jul 2025
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