Cervicogenic Concussion Rehabilitation With TopSpin360

NCT04159298 | Unknown

• 1 other identifier: CCRT360
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

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.

Conditions

Concussion, Mild

Keywords

rehabilitation; sports medicine; Test a New Treatment; randomized control trial

Outcome Measures

Primary Outcomes (3)

• Cervical Flexion-Rotation Test (CFRT)

  Static neck strength measurement tool

  8 weeks

• Multi-planar static neck strength (MicroFET2)

  Dynamic neck strength assessment tool

  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

  8 weeks

Secondary Outcomes (5)

• SCAT 5 Symptom Score

  8 weeks

• Neck Disability Index (NDI)

  8 weeks

• Headache Disability Inventory (HDI)

  8 weeks

• Global Disability Index

  8 weeks

• SF-36

  8 weeks

Study Arms (2)

Intervention

EXPERIMENTAL

Intervention group who will undergo the Top Spin 360 study protocol.

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.

Interventions

Top Spin 360 DEVICE

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

Intervention

Eligibility Criteria

• Age: 13 Years - 21 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• \> 28 symptoms cervicogenic symptoms

You may not qualify if:

• \< 28 symptoms
• no cervicogenic symptoms

Sponsors & Collaborators

• Western University, Canada: lead
• TopSpin Technologies Ltd: collaborator

Study Sites (1)

Fowler Kennedy Sports Medicine Clinic

London, Ontario, N6A 3K7, Canada

Location

MeSH Terms

Conditions

Brain Concussion

Condition Hierarchy (Ancestors)

Brain Injuries, Traumatic; Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Head Injuries, Closed; Wounds and Injuries; Wounds, Nonpenetrating

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Sport and Exercise Medicine

Study Record Dates

• First Submitted: October 30, 2019
• First Posted: November 12, 2019
• Study Start: April 1, 2020
• Primary Completion: October 1, 2021
• Study Completion: October 1, 2021
• Last Updated: November 12, 2019

Record last verified: 2019-11

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)