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出境医 / 临床实验 / Influence of Upper Extremity Vibration on Spasticity and Function in Persons With Tetraplegia

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

Study Description
Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Spinal Cord Injuries Tetraplegia Other: Vibrating ball Not Applicable

Study Design
Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 12 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Influence of Upper Extremity Vibration on Spasticity and Function in Persons With Tetraplegia
Actual Study Start Date : October 28, 2018
Actual Primary Completion Date : February 20, 2019
Actual Study Completion Date : February 20, 2019
Arms and Interventions
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.
Outcome Measures
Primary Outcome Measures :
  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 Outcome Measures :
  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


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations

Locations
Layout table for location information
United States, Georgia
Shepherd Center
Atlanta, Georgia, United States, 30309
Sponsors and Collaborators
Shepherd Center, Atlanta GA
Emory University
Tracking Information
First Submitted Date  ICMJE June 4, 2019
First Posted Date  ICMJE July 16, 2019
Last Update Posted Date July 16, 2019
Actual Study Start Date  ICMJE October 28, 2018
Actual Primary Completion Date February 20, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 15, 2019)
  • 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
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: July 15, 2019)
  • 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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Influence of Upper Extremity Vibration on Spasticity and Function in Persons With Tetraplegia
Official Title  ICMJE Influence of Upper Extremity Vibration on Spasticity and Function in Persons With Tetraplegia
Brief Summary 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Spinal Cord Injuries
  • Tetraplegia
Intervention  ICMJE Other: Vibrating ball
Parameters: 5 30-sec bouts of 68Hz vibration followed by a 1-minute rest.
Study Arms  ICMJE 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.
Intervention: Other: Vibrating ball
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 15, 2019) 		12
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE February 20, 2019
Actual Primary Completion Date February 20, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04020770
Other Study ID Numbers  ICMJE Shepherd
FV-765 ( Other Identifier: Shepherd Center )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Shepherd Center, Atlanta GA
Study Sponsor  ICMJE Shepherd Center, Atlanta GA
Collaborators  ICMJE Emory University
Investigators  ICMJE Not Provided
PRS Account Shepherd Center, Atlanta GA
Verification Date July 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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