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Vibration with tilt-table standing for Spinal Cord Injury

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Spinal Cord Injury+1 MoreVibration with tilt-table standing - Device
Eligibility
18 - 70
All Sexes
What conditions do you have?
Select

Study 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.

Eligible Conditions
  • Spinal Cord Injury
  • Spasticity

Treatment Effectiveness

Effectiveness Progress

1 of 3

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Study Objectives

1 Primary · 2 Secondary · Reporting Duration: Participants will be followed for the duration of the 3 treatments, an expected average of 1 week

Week 1
Subject Global Impression of Change (SGIC)
Week 1
Adverse Events
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
Change from Baseline in the Spinal Cord Injury Spasticity Evaluation Tool (SCI-SET) score after the third treatment

Trial Safety

Safety Progress

1 of 3

Similar Trials

1
Rituximab
1
LGK974
1
NNC0361-0041

Trial Design

1 Treatment Group

Vibration with tilt-table standing
1 of 1

Experimental Treatment

40 Total Participants · 1 Treatment Group

Primary Treatment: Vibration with tilt-table standing · No Placebo Group · N/A

Vibration with tilt-table standing
Device
Experimental Group · 1 Intervention: Vibration with tilt-table standing · Intervention Types: Device

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: participants will be followed for the duration of the 3 treatments, an expected average of 1 week

Who is running the clinical trial?

Kessler FoundationLead Sponsor
155 Previous Clinical Trials
10,275 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

Eligibility Criteria

Age 18 - 70 · All Participants · 8 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You are able to give informed consent.
You are 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.
You have a male or female, 18 to 70 years of age, inclusive.
You have a spinal cord injury that occurred at least six (6) months prior to the study.
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).
References

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