Spinal Cord Injuries Clinical Trial
Official title:
Influence of Upper Extremity Vibration on Spasticity and Function in Persons With Tetraplegia
Verified date | July 2019 |
Source | Shepherd Center, Atlanta GA |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 12 |
Est. completion date | February 20, 2019 |
Est. primary completion date | February 20, 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 65 Years |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
United States | Shepherd Center | Atlanta | Georgia |
Lead Sponsor | Collaborator |
---|---|
Shepherd Center, Atlanta GA | Emory University |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | |
Primary | 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 | |
Primary | 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 | |
Primary | Satisfaction and Adherence Questionnaire | Self- report of satisfaction with and perceived ability to adhere to the intervention | 20 minute delay post intervention | |
Secondary | Hand strength | Dynamometer measurement of grip strength | Pre-intervention, immediately post-intervention, 20 minute delay post intervention | |
Secondary | Pinch strength | Lateral pinch strength measured using a pinch meter | Pre-intervention, immediately post-intervention, 20 minute delay post intervention | |
Secondary | Semmes-Weinstein Monofilament Test | Assesment of light touch sensation | Pre-intervention, immediately post-intervention, 20 minute delay post intervention | |
Secondary | Qualities of Spasticity Questionnaire | Self-report of experience of spasticity | Baseline |
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