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

N/ACompletedNCT04020770

Shepherd Center, Atlanta GA12 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Spinal Cord Injuries Tetraplegia

Interventions

Vibrating ballOTHER

Parameters: 5 30-sec bouts of 68Hz vibration followed by a 1-minute rest.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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

Locations (1)

Shepherd Center

Atlanta, Georgia, United States

Outcomes

Primary Outcomes

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

Time frame: 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.

Time frame: 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

Time frame: Day 1

Satisfaction and Adherence Questionnaire

Self- report of satisfaction with and perceived ability to adhere to the intervention

Time frame: 20 minute delay post intervention

Secondary Outcomes

Hand strength

Dynamometer measurement of grip strength

Time frame: Pre-intervention, immediately post-intervention, 20 minute delay post intervention

Pinch strength

Lateral pinch strength measured using a pinch meter

Time frame: Pre-intervention, immediately post-intervention, 20 minute delay post intervention

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.