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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 up to 5 years

Awards & highlights

No Placebo-Only Group

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.

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.

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

0 / 10Eligibility criteria met