Clinical trial NCT04020770: Influence of Upper Extremity Vibration on Spasticity and Function in Persons With Tetraplegia
Official title: Influence of Upper Extremity Vibration on Spasticity and Function in Persons With Tetraplegia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Spinal Cord Injuries
Tetraplegia
Lead sponsor: Shepherd Center, Atlanta GA
Sponsor class: OTHER
Collaborators: name: Emory University
First posted: 2019-07-16
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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. The aim of this study is to investigate the feasibility of using a portable vibrating device to decrease UE spasticity.


Eligibility criteria: 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

Primary outcomes:
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
timeFrame: Day 1
measure: 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
timeFrame: Day 1
measure: 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
timeFrame: Day 1
measure: Satisfaction and Adherence Questionnaire
timeFrame: 20 minute delay post intervention
Secondary outcomes:
measure: Hand strength
timeFrame: Pre-intervention, immediately post-intervention, 20 minute delay post intervention
measure: Pinch strength
timeFrame: Pre-intervention, immediately post-intervention, 20 minute delay post intervention
measure: Semmes-Weinstein Monofilament Test
timeFrame: Pre-intervention, immediately post-intervention, 20 minute delay post intervention
measure: Qualities of Spasticity Questionnaire
timeFrame: Baseline
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Shepherd Center
state: Georgia
Study officials:
References: