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Cervicogenic Concussion Rehabilitation With TopSpin360

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04159298
Recruitment Status : Not yet recruiting
First Posted : November 12, 2019
Last Update Posted : November 12, 2019
Sponsor:
Collaborator:
TopSpin Technologies Ltd
Information provided by (Responsible Party):
Dr. Lisa Fischer, Western University, Canada

Tracking Information
First Submitted Date  ICMJE October 30, 2019
First Posted Date  ICMJE November 12, 2019
Last Update Posted Date November 12, 2019
Estimated Study Start Date  ICMJE April 1, 2020
Estimated Primary Completion Date October 1, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 6, 2019)
  • Cervical Flexion-Rotation Test (CFRT) [ Time Frame: 8 weeks ]
    Static neck strength measurement tool
  • Multi-planar static neck strength (MicroFET2) [ Time Frame: 8 weeks ]
    Dynamic neck strength assessment tool
  • Deep neck flexor endurance test [ Time Frame: 8 weeks ]
    Timed test to determine how long a participant can hold an isometric contraction of the deep neck flexor
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: November 6, 2019)
  • SCAT 5 Symptom Score [ Time Frame: 8 weeks ]
    22 item symptom checklist using a 7 point likert scale from 0 to 6 (0 absence of symptom, 1-2 mild severity, 3-4 moderate severity, 5-6 severe)
  • Neck Disability Index (NDI) [ Time Frame: 8 weeks ]
    Functional status questionnaire with 10 items including pain, personal care, lifting, reading, headaches, concentration, work, driving, sleeping and recreation.
  • Headache Disability Inventory (HDI) [ Time Frame: 8 weeks ]
    Consists of 40 items, each requiring a "yes" (four points), "sometimes" (two points), or "no" (zero points) response based on items derived empirically from case history responses of subjects with headache.
  • Global Disability Index [ Time Frame: 8 weeks ]
    25 item self reported instrument assessing different aspects of disability
  • SF-36 [ Time Frame: 8 weeks ]
    36-item self-report measure of health-related quality of life
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 Cervicogenic Concussion Rehabilitation With TopSpin360
Official Title  ICMJE Novel Multi-planar Neuromuscular Neck Strengthening for the Treatment of Delayed Recovery of Concussion in Adolescence and Young Adults With Cervicogenic Symptoms
Brief Summary Concussions occur most frequently in adolescents and often result in significant disruption to daily living for prolonged periods of time. Concussions are an epidemic, with the incidence rates for sports related concussions (SRC) in adolescents up to 0.47 per 1000 athlete exposures. Research would suggest that multi-planar neck strength is a protective factor of SRC risk in adolescents as greater neck strength is associated with a lower SRC risk.(Collins et al) Neck pain is a common symptom associated with SRC that is also associated with prolonged recovery from SRC. (King et al, Van der Naalt et al) Neck pain is also associated with decreased neck muscle strength (DeKoning et al). Our study will address a critical gap in concussion management - multi-planar cervical spine strengthening to specifically rehabilitate the cervicogenic component of prolonged post-concussion symptoms with a cervicogenic component and determine if this approach restores normal neck strength, decreases neck pain and headaches, improves daily global function and allow patients to return to sport and school. work more quickly than those without specific multi-planar neck strengthening.
Detailed Description

Overall Design: This will be a randomized clinical trial using a prospective cohort model. A total of 56 adolescents/young adults with concussion symptoms that persist >4 weeks post-trauma and +ve screening for cervical involvement (rated neck pain as a symptom, TOP para cervical or suboccipital spine, +ve cervical flexion-rotation test (Hall et al)) will be assigned randomly into one of two groups: 1) Control group who undergo traditional usual clinical care comprised of bi-weekly physiotherapy sessions and home-based exercise programs (TRADITIONAL), and 2) In combination with standard clinical care as described above, 2 sessions per week training on the TopSpin360 (protocol outlined below). (INTERVENTION). The intervention will last up to 7 weeks or until medical clearance to return to normal daily activities. Balancing as much as possible the impact of age and sport is critical because mechanisms and patterns of injury differ with the patient and the sport in which the concussion occurred. The randomization process will balance the influence of one's sex on the measured outcomes.

Randomization: Patients will be randomized into one of the two groups using a 1:1 ratio to balance recruitment and covariates. A random number generator will be used to assign groups.

Test Sequence: Based on previous work, it is anticipated that 7 weeks of intervention will be required. (Versteegh et al) Following baseline measures (Week 0) upon study entry, tests will be conducted at the midway point (4 weeks) and upon completion (7 weeks) or upon medical clearance to return to sport. The test sessions ideally will occur following the clinical examination with the physician . This will increase convenience for the patient's family who, for this age group, will be with the patient. At each test session a physiotherapist will bring the participant through 1. Cervical Flexion-Rotation test, 2. Deep neck flexor endurance test, 3. a multi-planar static neck strength assessment using a handheld dynamometer (Versteegh et al), 4. Dynamic necks strength assessed via peak RPM and time to complete 20 revolutions clockwise and counterclockwise on the TopSpin360, 5. Joint position error testing (Revel et al), 6. and complete standard questionnaires: SCAT 5 symptom score, Neck Disability Index, Headache Inventory and

Intervention training protocol using TopSpin360: Participants allocated to the INTERVENTION group will participate in 2 training sessions per week using the TopSpin360 neuromuscular neck-training device. Each session will be separated by a minimum of 2 days. Given the target population for this study will include younger subjects than previous training studies using the TopSpin360 and given they will have some neck pathology, a significantly reduced training load (number of revolutions used per set) will be used. The advantage of the TopSpin360 as a training tool is its safety profile in that the device uses self-generated resistance to create the muscular load and training effect.

The attached weight is only 125gm, and the resistance is generated through the centripetal force created as the participant swings the weight about the centrally mounted axis. Much like a hula-hoop, the participant is only capable of spinning the weight as quickly as his or her neck muscles and coordination are capable of getting it spinning, if they fatigue or lose coordination, the weight stops spinning and the resistance is removed. The first 2 weeks will involve 3 sets of 20 revolutions in each direction of clockwise and counterclockwise. Weeks 3 and 4 will involve 3 sets of 30 revolutions in each direction and weeks 4-7 will involve 3 sets of 40 revolutions in each direction.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Condition  ICMJE Concussion, Mild
Intervention  ICMJE Device: Top Spin 360
The TopSpin360 is a dynamic multi-planar neuromuscular training device that has been shown to improve static and dynamic multi-planar neck strength in a healthy athletic population
Study Arms  ICMJE
  • Experimental: Intervention
    Intervention group who will undergo the Top Spin 360 study protocol.
    Intervention: Device: Top Spin 360
  • No Intervention: Traditional
    Control group who undergo traditional usual clinical care comprised of bi-weekly physiotherapy sessions and home-based exercise programs.
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 Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: November 6, 2019)
56
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE October 1, 2021
Estimated Primary Completion Date October 1, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • > 28 symptoms cervicogenic symptoms

Exclusion Criteria:

  • < 28 symptoms
  • no cervicogenic symptoms
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 13 Years to 21 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Listed Location Countries  ICMJE Canada
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04159298
Other Study ID Numbers  ICMJE CCRT360
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 Dr. Lisa Fischer, Western University, Canada
Study Sponsor  ICMJE Western University, Canada
Collaborators  ICMJE TopSpin Technologies Ltd
Investigators  ICMJE Not Provided
PRS Account Western University, Canada
Verification Date November 2019

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