Cervicogenic Concussion Rehabilitation With TopSpin360

Concussion, Mild Clinical Trial

Official title:

Novel Multi-planar Neuromuscular Neck Strengthening for the Treatment of Delayed Recovery of Concussion in Adolescence and Young Adults With Cervicogenic Symptoms

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04159298
• Other study ID #: CCRT360
• Status: Not yet recruiting
• Phase: N/A
• Start date: April 1, 2020
• Est. completion date: October 1, 2021

Study information

• Verified date: November 2019
• Source: Western University, Canada
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 56
• Est. completion date: October 1, 2021
• Est. primary completion date: October 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 13 Years to 21 Years

Eligibility

Inclusion Criteria:

• > 28 symptoms cervicogenic symptoms

Exclusion Criteria:

• < 28 symptoms

• no cervicogenic symptoms

Related Conditions & MeSH terms

• Brain Concussion
• Concussion, Mild

Intervention

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

Locations

Country	Name	City	State
Canada	Fowler Kennedy Sports Medicine Clinic	London	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
Western University, Canada	TopSpin Technologies Ltd

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cervical Flexion-Rotation Test (CFRT)	Static neck strength measurement tool	8 weeks
Primary	Multi-planar static neck strength (MicroFET2)	Dynamic neck strength assessment tool	8 weeks
Primary	Deep neck flexor endurance test	Timed test to determine how long a participant can hold an isometric contraction of the deep neck flexor	8 weeks
Secondary	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)	8 weeks
Secondary	Neck Disability Index (NDI)	Functional status questionnaire with 10 items including pain, personal care, lifting, reading, headaches, concentration, work, driving, sleeping and recreation.	8 weeks
Secondary	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.	8 weeks
Secondary	Global Disability Index	25 item self reported instrument assessing different aspects of disability	8 weeks
Secondary	SF-36	36-item self-report measure of health-related quality of life	8 weeks