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Completed

NCT Number: NCT04020770

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.

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Key information

Conditions

Spinal Cord Injuries Central Nervous System Diseases Nervous System Diseases Neurologic Manifestations Paralysis Pathological Conditions, Signs and Symptoms Quadriplegia Signs and Symptoms Spinal Cord Diseases Tetraplegia Trauma, Nervous System Wounds and Injuries

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Shepherd Center

Atlanta, Georgia, 30309, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Vibrating ball

Other

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

Primary outcomes

  1. 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

  2. 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.

  3. 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

  4. 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 outcomes

  1. Hand strength

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

    Dynamometer measurement of grip strength

  2. Pinch strength

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

    Lateral pinch strength measured using a pinch meter

  3. Semmes-Weinstein Monofilament Test

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

    Assesment of light touch sensation

  4. Qualities of Spasticity Questionnaire

    Time frame: Baseline

    Self-report of experience of spasticity

Sponsors and collaborators

Lead sponsor

Shepherd Center, Atlanta GA

Other

Collaborators

  • Emory University

Registry information

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Jul 16, 2019
Registry last updated
Jul 16, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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