Cervicogenic Concussion Rehabilitation With TopSpin360
Primary Purpose
Concussion, Mild
Status
Unknown status
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Top Spin 360
Sponsored by
About this trial
This is an interventional supportive care trial for Concussion, Mild focused on measuring rehabilitation, sports medicine, Test a New Treatment, randomized control trial
Eligibility Criteria
Inclusion Criteria:
- > 28 symptoms cervicogenic symptoms
Exclusion Criteria:
- < 28 symptoms
- no cervicogenic symptoms
Sites / Locations
- Fowler Kennedy Sports Medicine Clinic
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Intervention
Traditional
Arm Description
Intervention group who will undergo the Top Spin 360 study protocol.
Control group who undergo traditional usual clinical care comprised of bi-weekly physiotherapy sessions and home-based exercise programs.
Outcomes
Primary Outcome Measures
Cervical Flexion-Rotation Test (CFRT)
Static neck strength measurement tool
Multi-planar static neck strength (MicroFET2)
Dynamic neck strength assessment tool
Deep neck flexor endurance test
Timed test to determine how long a participant can hold an isometric contraction of the deep neck flexor
Secondary Outcome Measures
SCAT 5 Symptom Score
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)
Functional status questionnaire with 10 items including pain, personal care, lifting, reading, headaches, concentration, work, driving, sleeping and recreation.
Headache Disability Inventory (HDI)
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
25 item self reported instrument assessing different aspects of disability
SF-36
36-item self-report measure of health-related quality of life
Full Information
NCT ID
NCT04159298
First Posted
October 30, 2019
Last Updated
November 6, 2019
Sponsor
Western University, Canada
Collaborators
TopSpin Technologies Ltd
1. Study Identification
Unique Protocol Identification Number
NCT04159298
Brief Title
Cervicogenic Concussion Rehabilitation With TopSpin360
Official Title
Novel Multi-planar Neuromuscular Neck Strengthening for the Treatment of Delayed Recovery of Concussion in Adolescence and Young Adults With Cervicogenic Symptoms
Study Type
Interventional
2. Study Status
Record Verification Date
November 2019
Overall Recruitment Status
Unknown status
Study Start Date
April 1, 2020 (Anticipated)
Primary Completion Date
October 1, 2021 (Anticipated)
Study Completion Date
October 1, 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Western University, Canada
Collaborators
TopSpin Technologies Ltd
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Concussion, Mild
Keywords
rehabilitation, sports medicine, Test a New Treatment, randomized control trial
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
56 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Intervention
Arm Type
Experimental
Arm Description
Intervention group who will undergo the Top Spin 360 study protocol.
Arm Title
Traditional
Arm Type
No Intervention
Arm Description
Control group who undergo traditional usual clinical care comprised of bi-weekly physiotherapy sessions and home-based exercise programs.
Intervention Type
Device
Intervention Name(s)
Top Spin 360
Intervention Description
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
Primary Outcome Measure Information:
Title
Cervical Flexion-Rotation Test (CFRT)
Description
Static neck strength measurement tool
Time Frame
8 weeks
Title
Multi-planar static neck strength (MicroFET2)
Description
Dynamic neck strength assessment tool
Time Frame
8 weeks
Title
Deep neck flexor endurance test
Description
Timed test to determine how long a participant can hold an isometric contraction of the deep neck flexor
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
SCAT 5 Symptom Score
Description
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)
Time Frame
8 weeks
Title
Neck Disability Index (NDI)
Description
Functional status questionnaire with 10 items including pain, personal care, lifting, reading, headaches, concentration, work, driving, sleeping and recreation.
Time Frame
8 weeks
Title
Headache Disability Inventory (HDI)
Description
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.
Time Frame
8 weeks
Title
Global Disability Index
Description
25 item self reported instrument assessing different aspects of disability
Time Frame
8 weeks
Title
SF-36
Description
36-item self-report measure of health-related quality of life
Time Frame
8 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
13 Years
Maximum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
> 28 symptoms cervicogenic symptoms
Exclusion Criteria:
< 28 symptoms
no cervicogenic symptoms
Facility Information:
Facility Name
Fowler Kennedy Sports Medicine Clinic
City
London
State/Province
Ontario
ZIP/Postal Code
N6A 3K7
Country
Canada
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lisa Fischer, MD
Phone
519 661 3011
First Name & Middle Initial & Last Name & Degree
Stacey Wanlin
Phone
519 661 3011
First Name & Middle Initial & Last Name & Degree
Doug Fraser, MD
First Name & Middle Initial & Last Name & Degree
Laura Graham, PT, PhD
First Name & Middle Initial & Last Name & Degree
Michael Robinson, PhD
First Name & Middle Initial & Last Name & Degree
Lisa Fishcer, MD
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Cervicogenic Concussion Rehabilitation With TopSpin360
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