Influence of Upper Extremity Vibration on Spasticity and Function in Persons With Tetraplegia
- Conditions
- Spinal Cord InjuriesTetraplegia
- Interventions
- Other: Vibrating ball
- Registration Number
- NCT04020770
- Lead Sponsor
- Shepherd Center, Atlanta GA
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 12
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Vibrating Ball Vibrating ball 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.
- Primary Outcome Measures
Name Time Method Satisfaction and Adherence Questionnaire 20 minute delay post intervention Self- report of satisfaction with and perceived ability to adhere to the intervention
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 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 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 Outcome Measures
Name Time Method Hand strength Pre-intervention, immediately post-intervention, 20 minute delay post intervention Dynamometer measurement of grip strength
Qualities of Spasticity Questionnaire Baseline Self-report of experience of spasticity
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
Trial Locations
- Locations (1)
Shepherd Center
🇺🇸Atlanta, Georgia, United States