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

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

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: February 20, 2019

Interventions

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

Arms, Groups and Cohorts

  • Experimental: 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.

Clinical Trial Outcome Measures

Primary Measures

  • 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
    • Time Frame: 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
    • Time Frame: 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
    • Time Frame: 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
  • Satisfaction and Adherence Questionnaire
    • Time Frame: 20 minute delay post intervention
    • Self- report of satisfaction with and perceived ability to adhere to the intervention

Secondary Measures

  • Hand strength
    • Time Frame: Pre-intervention, immediately post-intervention, 20 minute delay post intervention
    • Dynamometer measurement of grip strength
  • Pinch strength
    • Time Frame: Pre-intervention, immediately post-intervention, 20 minute delay post intervention
    • Lateral pinch strength measured using a pinch meter
  • Semmes-Weinstein Monofilament Test
    • Time Frame: Pre-intervention, immediately post-intervention, 20 minute delay post intervention
    • Assesment of light touch sensation
  • Qualities of Spasticity Questionnaire
    • Time Frame: Baseline
    • Self-report of experience of spasticity

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 65 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Shepherd Center, Atlanta GA
  • Collaborator
    • Emory University
  • Provider of Information About this Clinical Study
    • Sponsor

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