Influence of Upper Extremity Vibration on Spasticity and Function in Persons With Tetraplegia

Study Overview
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Brief Summary
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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.

Official Title
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Influence of Upper Extremity Vibration on Spasticity and Function in Persons With Tetraplegia

Conditions
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Spinal Cord Injuries, Tetraplegia

Intervention / Treatment
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* Other: Vibrating ball


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Vibrating Ball<br>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. | Other: Vibrating ball<br>* Parameters: 5 30-sec bouts of 68Hz vibration followed by a 1-minute rest.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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. | 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 | Day 1 | 
| Satisfaction and Adherence Questionnaire | Self- report of satisfaction with and perceived ability to adhere to the intervention | 20 minute delay post intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hand strength | Dynamometer measurement of grip strength | Pre-intervention, immediately post-intervention, 20 minute delay post intervention | 
| Pinch strength | Lateral pinch strength measured using a pinch meter | Pre-intervention, immediately post-intervention, 20 minute delay post intervention | 
| Semmes-Weinstein Monofilament Test | Assesment of light touch sensation | Pre-intervention, immediately post-intervention, 20 minute delay post intervention | 
| Qualities of Spasticity Questionnaire | Self-report of experience of spasticity | Baseline |