Spinal Cord Injuries, Tetraplegia
Conditions
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.
Interventions
OTHERVibrating ball
Parameters: 5 30-sec bouts of 68Hz vibration followed by a 1-minute rest.
Sponsors
Emory University
Shepherd Center, Atlanta GA
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Satisfaction and Adherence Questionnaire | 20 minute delay post intervention | Self- report of satisfaction with and perceived ability to adhere to the intervention |
| 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 | 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 | 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 | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Hand strength | Pre-intervention, immediately post-intervention, 20 minute delay post intervention | Dynamometer measurement of grip strength |
| Pinch strength | Pre-intervention, immediately post-intervention, 20 minute delay post intervention | Lateral pinch strength measured using a pinch meter |
| Semmes-Weinstein Monofilament Test | Pre-intervention, immediately post-intervention, 20 minute delay post intervention | Assesment of light touch sensation |
| Qualities of Spasticity Questionnaire | Baseline | Self-report of experience of spasticity |
Countries
United States
Outcome results
None listed