Spinal Cord InjuryNCT02127606
The Effect of Whole Body Vibration on Spasticity in Persons With Spinal Cord Injury
A study testing Vibration with tilt-table standing in people with Spinal Cord Injury and Spasticity, run by Kessler Foundation at 1 site in United States.
Trial summary
Extended periods of tilt table standing have been observed to improve spasticity in individuals with spinal cord injury (SCI). The purpose of this study is to determine the effect of three sessions of whole body vibration while tilt table standing on spasticity in individuals with a complete or incomplete SCI above… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Spinal Cord Injury, Spasticity
- What is being tested?
- Vibration with tilt-table standing
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2014to Jul 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The subject is male or female, 18 to 70 years of age, inclusive.
- The subject has neurological impairment secondary to a spinal cord injury that occurred at least six (6) months prior to the study that can be categorized as either a complete or incomplete spinal cord injury.
- The neurological level of lesion is above T10.
- The subject has self-reported stable moderate to severe spasticity (Modified Ashworth Score scale at or greater than a 2 at the hips or knees). Patients can be enrolled if on a stable dose of oral medications or intrathecal medications.
- 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.
- The subject is able and willing to comply with the protocol.
- The subject is able to and has voluntarily given informed consent prior to the performance of any study-specific procedures.
Who cannot join
- The subject does not self report lower limb spasticity.
- The subject does not have 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 experiences symptoms consistent with infection, including but not limited to fever, chills, dysuria, gallbladder or kidney stones.
- 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.
- The subject has a lumbar spinal hardware or artificial joints in the lower extremities.
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- The subject is participating in any experimental studies that could alter the patient's spasticity.
- The subject has a concomitant brain injury or other cognitive deficits that would preclude following instructions.
- The subject has skin breakdown in areas receiving direct pressure during tilt table standing.
- The subject has any medical condition, including psychiatric disease that would interfere with the interpretation of the study results or the conduct of the study.
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Kessler Institute for Rehabilitation
West Orange, New Jersey, 07052
Trevor A. Dyson-Hudson, M.D., 973-324-3576, tdysonhudson@kesslerfoundation.org
Matthew Weiner, 973-324-3515, mweiner@kesslerfoundation.org
About this study
Official title: The Effect of Whole Body Vibration on Spasticity in Spinal Cord Injury Patients
Extended periods of tilt table standing have been observed to improve spasticity in individuals with spinal cord injury (SCI). The purpose of this study is to determine the effect of three sessions of whole body vibration while tilt table standing on spasticity in individuals with a complete or incomplete SCI above the neurological level of T10. Participants in this study will undergo whole body vibration while standing on a tilt table for a total of approximately 14 minutes for a total of 3 sessions on 3 separate days. Spasticity monitoring will be evaluated prior to and after the intervention with the Modified Penn Spasm Frequency Scale, an interview to obtain the individual's perception and impression of the effect of whole body vibration on the performance of activities of daily living, quality of life, pain scale, and global impression of change.
- Conditions
- Spinal Cord Injury, Spasticity
- Being tested
- Vibration with tilt-table standing
- Medical subject headings
- Spinal Cord Injuries, Muscle Spasticity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vibration with tilt-table standingDevice
Also called Galileo Tilt-Table, Galileo System, Vibrating platform, Whole-body vibration with tilt-table standing
| Study group | Role | What they receive |
|---|---|---|
| Vibration with tilt-table standing | Experimental | 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 Receives: Device: Vibration with tilt-table standing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline in the Spinal Cord Injury Spasticity Evaluation Tool (SCI-SET) score after the third treatment
Measured: Participants will be followed for the duration of the 3 treatments, an expected average of 1 week
Secondary outcomes (2)
Change from Baseline in the Pain Severity Numerical Rating Scale (NRS) score after the third treatment
Measured: Participants will be followed for the duration of the 3 treatments, an expected average of 1 week
Change from Baseline in the Penn Spasm Frequency Scale score after the third treatment
Measured: Participants will be followed for the duration of the 3 treatments, an expected average of 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2014 (estimated)
- Study startApr 2014
- Primary completionJul 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spinal Cord InjuryStudies of the same condition, open and under way.
- More trials run by Kessler FoundationThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kessler Foundation
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Steven C. Kirshblum, M.D., Principal investigator, Kessler Institute for RehabilitationTrevor A. Dyson-Hudson, M.D., Principal investigator, Kessler Foundation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02127606
- Sponsor's protocol ID
- R-811-14
- Status last verified
- Nov 2014
- First submitted
- 24 Apr 2014
- Last updated
- 26 Nov 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Nov 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Whole Body Vibration on Spasticity in Spinal Cord Injury Patients
- ClinicalTrials.gov ID
- NCT02127606
- Acronym / sponsor ID
- R-811-14
- Conditions
- Spinal Cord Injury, Spasticity
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Kessler FoundationUniversity, hospital or other
- Study start
- Apr 2014
- Primary completion
- Jul 2015 (estimated)
- First posted
- 30 Apr 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Extended periods of tilt table standing have been observed to improve spasticity in individuals with spinal cord injury (SCI). The purpose of this study is to determine the effect of three sessions of whole body vibration while tilt table standing on spasticity in individuals with a complete or incomplete SCI above the neurological level of T10. Participants in this study will undergo whole body vibration while standing on a tilt table for a total of approximately 14 minutes for a total of 3 sessions on 3 separate days. Spasticity monitoring will be evaluated prior to and after the intervention with the Modified Penn Spasm Frequency Scale, an interview to obtain the individual's perception and impression of the effect of whole body vibration on the performance of activities of daily living, quality of life, pain scale, and global impression of change.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Vibration with tilt-table standing | Experimental | Device: Vibration with tilt-table standingParticipants 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 |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- The subject is male or female, 18 to 70 years of age, inclusive.
- The subject has neurological impairment secondary to a spinal cord injury that occurred at least six (6) months prior to the study that can be categorized as either a complete or incomplete spinal cord injury.
- The neurological level of lesion is above T10.
- The subject has self-reported stable moderate to severe spasticity (Modified Ashworth Score scale at or greater than a 2 at the hips or knees). Patients can be enrolled if on a stable dose of oral medications or intrathecal medications.
- 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).
Key exclusion criteria (10 listed)
- The subject does not self report lower limb spasticity.
- The subject does not have 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 experiences symptoms consistent with infection, including but not limited to fever, chills, dysuria, gallbladder or kidney stones.
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vibration with tilt-table standingAlso: Galileo Tilt-Table, Galileo System, Vibrating platform, Whole-body vibration with tilt-table standing | Device | Vibration with tilt-table standing |
Primary outcome
Change from Baseline in the Spinal Cord Injury Spasticity Evaluation Tool (SCI-SET) score after the third treatment
Time frame: Participants will be followed for the duration of the 3 treatments, an expected average of 1 week
2 secondary outcomes
Change from Baseline in the Pain Severity Numerical Rating Scale (NRS) score after the third treatment
Time frame: Participants will be followed for the duration of the 3 treatments, an expected average of 1 week
Change from Baseline in the Penn Spasm Frequency Scale score after the third treatment
Time frame: Participants will be followed for the duration of the 3 treatments, an expected average of 1 week
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Nov 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Steven C. Kirshblum, M.D. principal investigator
Kessler Institute for Rehabilitation
Trevor A. Dyson-Hudson, M.D. principal investigator
Kessler Foundation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vibration with tilt-table standing in people with Spinal Cord Injury and Spasticity, run by Kessler Foundation at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 Nov 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Trevor A. Dyson-Hudson, M.D. (973-324-3576, tdysonhudson@kesslerfoundation.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline in the Spinal Cord Injury Spasticity Evaluation Tool (SCI-SET) score after the third treatment (time frame: Participants will be followed for the duration of the 3 treatments, an expected average of 1 week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Nov 2014.