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

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 Overview

• Status: Completed
• Conditions: Spinal Cord Injuries; Tetraplegia
• Intervention / Treatment: Other: Vibrating ball

• Study Type: Interventional
• Enrollment (Actual): 12
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Georgia
    • Atlanta, Georgia, United States, 30309
      • Shepherd Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	Other: Vibrating ball; Parameters: 5 30-sec bouts of 68Hz vibration followed by a 1-minute rest.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Shepherd Center, Atlanta GA
• Collaborators: Emory University

Study record dates

Study Major Dates

• Study Start (ACTUAL): October 28, 2018
• Primary Completion (ACTUAL): February 20, 2019
• Study Completion (ACTUAL): February 20, 2019

Study Registration Dates

• First Submitted: June 4, 2019
• First Submitted That Met QC Criteria: July 15, 2019
• First Posted (ACTUAL): July 16, 2019

Study Record Updates

• Last Update Posted (ACTUAL): July 16, 2019
• Last Update Submitted That Met QC Criteria: July 15, 2019
• Last Verified: July 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Central Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Wounds and Injuries; Trauma, Nervous System; Spinal Cord Diseases; Paralysis; Spinal Cord Injuries; Quadriplegia
• Other Study ID Numbers: SHEPHERD; FV-765 (OTHER: Shepherd Center)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No