Spinal Cord InjuriesNCT04020770
Influence of Upper Extremity Vibration on Spasticity and Function in Persons With Tetraplegia
A study testing Vibrating ball in people with Spinal Cord Injuries and Tetraplegia, run by Shepherd Center, Atlanta GA at 1 site in United States.
Trial summary
Vibration therapy is a possible alternative to drug-based treatments for spasticity following SCI. Research indicates that it may provide temporary relief from spasticity, but many interventions under investigation are not portable and therefore access is limited. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Spinal Cord Injuries, Tetraplegia
- What is being tested?
- Vibrating ball
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Oct 2018to 20 Feb 2019
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Have sustained cervical (neurological level C1-C8) SCI
- Any ISNCSCI severity classification (A, B, C or D)
- Have therapist-reported and self-reported spasticity in the arm or hand
- Ability to pick up, move, and release at least one block (on the Box \& Blocks Test)
- May participate if utilizing prescription medications, including baclofen pump for control of spasticity
Who cannot join
- Severe contractures of the arm/hand that limit passive movement of the elbow, wrist or fingers more than 50% of normal range of motion or presence of other orthopedic pathology that would adversely influence participation in the protocol
- Any implanted catheter such as but not limited to CSF shunt, or the presence of pacemaker, implanted automatic internal cardioverter defibrillator (AICD, other cardiac implants and or conditions). Not including baclofen pump.
- Severe pain or hypersensitivity of the arm/hand
- Current pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
Vibration therapy is a possible alternative to drug-based treatments for spasticity following SCI. Research indicates that it may provide temporary relief from spasticity, but many interventions under investigation are not portable and therefore access is limited. The aim of this study is to investigate the feasibility of using a portable vibrating device to decrease UE spasticity.
- Conditions
- Spinal Cord Injuries, Tetraplegia
- Being tested
- Vibrating ball
- Medical subject headings
- Spinal Cord Injuries, Quadriplegia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vibrating ballOther
Parameters: 5 30-sec bouts of 68Hz vibration followed by a 1-minute rest.
| Study group | Role | What they receive |
|---|---|---|
| Vibrating Ball | Experimental | Vibrating ball is held in both hands. Participants complete 5 30-second bouts of 68 Hz vibration with a 1 minute rest in between each bout. Receives: Other: Vibrating ball |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Box and Blocks Test from pre-intervention to post intervention, from pre intervention to 20 minute follow up, from post intervention to 20 minute follow up
Functional assessment of grasp and release
Measured: Day 1
Change in Modified Ashworth Scale from pre-intervention to post intervention, from pre intervention to 20 minute follow up, from post intervention to 20 minute follow up
Clinical assessment of stretch-induced spasticity measured on a scale of 0-4 with 4 indicating the worst spasticity and 0 indicating no spasticity detectable upon clinical examination.
Measured: Day 1
Change in Global Impression of Change Scale from pre-intervention to post intervention, from pre intervention to 20 minute follow up, from post intervention to 20 minute follow up
Self-report of improvement or deterioration over time measured on a scale of 1-7 with 1 indicating very much improved and 7 indicating very much worse
Measured: Day 1
Satisfaction and Adherence Questionnaire
Self- report of satisfaction with and perceived ability to adhere to the intervention
Measured: 20 minute delay post intervention
Secondary outcomes (4)
Hand strength
Dynamometer measurement of grip strength
Measured: Pre-intervention, immediately post-intervention, 20 minute delay post intervention
Pinch strength
Lateral pinch strength measured using a pinch meter
Measured: Pre-intervention, immediately post-intervention, 20 minute delay post intervention
Semmes-Weinstein Monofilament Test
Assesment of light touch sensation
Measured: Pre-intervention, immediately post-intervention, 20 minute delay post intervention
Qualities of Spasticity Questionnaire
Self-report of experience of spasticity
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2019
- Study start28 Oct 2018
- Primary completion20 Feb 2019
- Study completion20 Feb 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spinal Cord InjuriesStudies of the same condition, open and under way.
- 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
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shepherd Center, Atlanta GA
- Sponsor type
- University, hospital or other
- Collaborators
- Emory University
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04020770
- Sponsor's protocol ID
- Shepherd
- Other IDs
- FV-765
- Status last verified
- Jul 2019
- First submitted
- 4 Jun 2019
- Last updated
- 16 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Upper Extremity Vibration on Spasticity and Function in Persons With Tetraplegia
- ClinicalTrials.gov ID
- NCT04020770
- Acronym / sponsor ID
- Shepherd
- Conditions
- Spinal Cord Injuries, Tetraplegia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Shepherd Center, Atlanta GAUniversity, hospital or other
- Collaborators
- Emory University
- Study start
- 28 Oct 2018 (actual)
- Primary completion
- 20 Feb 2019 (actual)
- Study completion
- 20 Feb 2019 (actual)
- First posted
- 16 Jul 2019 (actual)
- 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.
Vibration therapy is a possible alternative to drug-based treatments for spasticity following SCI. Research indicates that it may provide temporary relief from spasticity, but many interventions under investigation are not portable and therefore access is limited. The aim of this study is to investigate the feasibility of using a portable vibrating device to decrease UE spasticity.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Vibrating Ball | Experimental | Other: Vibrating ballVibrating ball is held in both hands. Participants complete 5 30-second bouts of 68 Hz vibration with a 1 minute rest in between each bout. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Have sustained cervical (neurological level C1-C8) SCI
- Any ISNCSCI severity classification (A, B, C or D)
- Have therapist-reported and self-reported spasticity in the arm or hand
- Ability to pick up, move, and release at least one block (on the Box \& Blocks Test)
- May participate if utilizing prescription medications, including baclofen pump for control of spasticity
Key exclusion criteria (4 listed)
- Severe contractures of the arm/hand that limit passive movement of the elbow, wrist or fingers more than 50% of normal range of motion or presence of other orthopedic pathology that would adversely influence participation in the protocol
- Any implanted catheter such as but not limited to CSF shunt, or the presence of pacemaker, implanted automatic internal cardioverter defibrillator (AICD, other cardiac implants and or conditions). Not including baclofen pump.
- Severe pain or hypersensitivity of the arm/hand
- Current pregnancy
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 |
|---|---|---|
| Vibrating ballParameters: 5 30-sec bouts of 68Hz vibration followed by a 1-minute rest. | Other | Vibrating Ball |
Primary outcome
Change in Box and Blocks Test from pre-intervention to post intervention, from pre intervention to 20 minute follow up, from post intervention to 20 minute follow up
Time frame: Day 1
Functional assessment of grasp and release
Change in Modified Ashworth Scale from pre-intervention to post intervention, from pre intervention to 20 minute follow up, from post intervention to 20 minute follow up
Time frame: Day 1
Clinical assessment of stretch-induced spasticity measured on a scale of 0-4 with 4 indicating the worst spasticity and 0 indicating no spasticity detectable upon clinical examination.
Change in Global Impression of Change Scale from pre-intervention to post intervention, from pre intervention to 20 minute follow up, from post intervention to 20 minute follow up
Time frame: Day 1
Self-report of improvement or deterioration over time measured on a scale of 1-7 with 1 indicating very much improved and 7 indicating very much worse
Satisfaction and Adherence Questionnaire
Time frame: 20 minute delay post intervention
Self- report of satisfaction with and perceived ability to adhere to the intervention
4 secondary outcomes
Hand strength
Time frame: Pre-intervention, immediately post-intervention, 20 minute delay post intervention
Pinch strength
Time frame: Pre-intervention, immediately post-intervention, 20 minute delay post intervention
Semmes-Weinstein Monofilament Test
Time frame: Pre-intervention, immediately post-intervention, 20 minute delay post intervention
Qualities of Spasticity Questionnaire
Time frame: Baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2019.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vibrating ball in people with Spinal Cord Injuries and Tetraplegia, run by Shepherd Center, Atlanta GA 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 5 inclusion and 4 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: finished, as of the sponsor's last update on 16 Jul 2019. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Box and Blocks Test from pre-intervention to post intervention, from pre intervention to 20 minute follow up, from post intervention to 20 minute follow up (time frame: Day 1). The study lists 4 primary outcomes in all. 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 16 Jul 2019.