Concussion, MildNCT04159298
Cervicogenic Concussion Rehabilitation With TopSpin360
A study testing Top Spin 360 in people with Concussion, Mild, run by Western University, Canada at 1 site in Canada.
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. Read more about this study
- Who is it for?
- Ages 13 years and older
- Conditions the study is for
- Concussion, Mild
- What is being tested?
- Top Spin 360
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 58 participants
- Where
- 1 siteCanada
- Study dates
- 6 May 2022to 2 Jan 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 13 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- > 28 symptoms cervicogenic symptoms
Who cannot join
- < 28 symptoms
- no cervicogenic symptoms
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Novel Multi-planar Neuromuscular Neck Strengthening for the Treatment of Delayed Recovery of Concussion in Adolescence and Young Adults With Cervicogenic Symptoms
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.
Read the 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 8 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 8 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 (8 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 4-8 will involve 3 sets of 40 revolutions in each direction.
- Conditions
- Concussion, Mild
- Being tested
- Top Spin 360
- Keywords
- rehabilitation, sports medicine, Test a New Treatment, randomized control trial
- Medical subject headings
- Brain Concussion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Top Spin 360Device
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 group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Intervention group who will undergo the Top Spin 360 study protocol. Receives: Device: Top Spin 360 |
| Traditional | No intervention | Control group who undergo traditional usual clinical care comprised of bi-weekly physiotherapy sessions and home-based exercise programs. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Multi-planar static neck strength (MicroFET2)
Static neck strength measurement tool
Measured: 8 weeks
Dynamic Neck Strength (TopSpin360)
Dynamic neck strength assessment tool
Measured: 8 weeks
Deep neck flexor endurance test
Timed test to determine how long a participant can hold an isometric contraction of the deep neck flexor
Measured: 8 weeks
Secondary outcomes (5)
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)
Measured: 8 weeks
Neck Disability Index (NDI)
Functional status questionnaire with 10 items including pain, personal care, lifting, reading, headaches, concentration, work, driving, sleeping and recreation.
Measured: 8 weeks
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.
Measured: 8 weeks
Global Disability Index
25 item self reported instrument assessing different aspects of disability
Measured: 8 weeks
SF-36
36-item self-report measure of health-related quality of life
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Nov 2019
- Study start6 May 2022
- Primary completion12 Dec 2023
- Study completion2 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Concussion, MildStudies of the same condition, open and under way.
- More trials run by Western University, CanadaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 58 participants (actual)
Sponsor and investigators
- Lead sponsor
- Western University, Canada
- Sponsor type
- University, hospital or other
- Collaborators
- TopSpin Technologies Ltd
- Responsible party
- Principal investigator, Dr. Lisa Fischer, Western University, Canada
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04159298
- Sponsor's protocol ID
- CCRT360
- Status last verified
- Jun 2026
- First submitted
- 30 Oct 2019
- Last updated
- 20 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Novel Multi-planar Neuromuscular Neck Strengthening for the Treatment of Delayed Recovery of Concussion in Adolescence and Young Adults With Cervicogenic Symptoms
- ClinicalTrials.gov ID
- NCT04159298
- Acronym / sponsor ID
- CCRT360
- Conditions
- Concussion, Mild
- Keywords
- rehabilitation, sports medicine, Test a New Treatment, randomized control trial
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 58 participants (actual)
- Lead sponsor
- Western University, CanadaUniversity, hospital or other
- Collaborators
- TopSpin Technologies Ltd
- Study start
- 6 May 2022 (actual)
- Primary completion
- 12 Dec 2023 (actual)
- Study completion
- 2 Jan 2024 (actual)
- First posted
- 12 Nov 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 8 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 8 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 (8 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 4-8 will involve 3 sets of 40 revolutions in each direction.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Device: Top Spin 360Intervention group who will undergo the Top Spin 360 study protocol. |
| Traditional | No intervention | –Control group who undergo traditional usual clinical care comprised of bi-weekly physiotherapy sessions and home-based exercise programs. |
Who may qualify
- Ages
- 13 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- > 28 symptoms cervicogenic symptoms
Key exclusion criteria (2 listed)
- < 28 symptoms
- no cervicogenic symptoms
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Top Spin 360The 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 | Device | Intervention |
Primary outcome
Multi-planar static neck strength (MicroFET2)
Time frame: 8 weeks
Static neck strength measurement tool
Dynamic Neck Strength (TopSpin360)
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
5 secondary outcomes
SCAT 5 Symptom Score
Time frame: 8 weeks
Neck Disability Index (NDI)
Time frame: 8 weeks
Headache Disability Inventory (HDI)
Time frame: 8 weeks
Global Disability Index
Time frame: 8 weeks
SF-36
Time frame: 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Top Spin 360 in people with Concussion, Mild, run by Western University, Canada at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Multi-planar static neck strength (MicroFET2) (time frame: 8 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Aug 2026.