NCT03844087

Brief Summary

The growing recognition of the short and long-term effects of head-neck trauma on athletes is stimulating the search for preventative measures while improving on-field performance. This study's goal is to evaluate the effect of a 12-week training protocol of the TopSpin360 neuromuscular training device on static and dynamic neck strength and sprinting performance in female varsity level athletes. This study will recruit athletes from the women's varsity soccer and rugby teams. As part of their standard out of season testing, they will have their static and dynamic neck strength, neck girth and 40 yard dash times assessed at inception into the study. The athletes will then be invited to participate in the TopSpin360 training program. This program incorporates training sessions on the TopSpin360 of 3-5 sets of 50 revolutions in each direction of clockwise and counterclockwise three times a week to improve static and dynamic neck strength but not sprint performance specifically. The sessions last 10-15 minutes and will run for 12 weeks. Members of the research team will supervise these training sessions 3 days per week as an addition to their out of season training program. Neck girth, static and dynamic neck strength and 40 yard dash times will be reassessed after the 12 week training intervention. The study hypothesis is that training on the TopSpin360 will result in improved static and dynamic neck strength and improved 40-yard dash times. A secondary hypothesis is that the change in neck strength will be positively associated with the change in 40-yard dash times, aligning with an emerging theory of athletic performance related to dynamic control of the entire kinetic chain including the neck. Routine re-evaluation of neck strength throughout the duration of the 12-week program will provide additional information on the trajectory of training effects and estimates of time-to-peak performance.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
87

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Mar 2019

Longer than P75 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 12, 2019

Completed
6 days until next milestone

First Posted

Study publicly available on registry

February 18, 2019

Completed
11 days until next milestone

Study Start

First participant enrolled

March 1, 2019

Completed
4.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2023

Completed
Last Updated

May 14, 2025

Status Verified

May 1, 2025

Enrollment Period

4.3 years

First QC Date

February 12, 2019

Last Update Submit

May 9, 2025

Conditions

Keywords

multiplanar, plyometric, neck strength

Outcome Measures

Primary Outcomes (3)

  • Change in static neck strength as measured using a handheld dynamometer

    Multiplanar static neck strength

    Change from Baseline Static Neck Strength after 12 weeks of training

  • Change in Dynamic neck strength

    Performance on the TopSpin360

    Change from Baseline Performance in Dynamic Neck Strength after12 weeks of training

  • Change in 40 yard dash time

    time to sprint 40 yards

    Change from Baseline 40 yard dash time after 12 weeks of training

Secondary Outcomes (2)

  • Change in Neck girth

    Change in Neck Girth after 12 weeks of training

  • Relationship between self-declared concussion history and static and neck strength

    As measured at Baseline

Study Arms (1)

multiplanar neuromuscular training arm

EXPERIMENTAL

The intervention arm will be involved in the training intervention outlined. Briefly, each participant will be asked to train on the TopSpin360 3 times per week for 3-5 sets for the duration of the study. Each set will take roughly 15-30 seconds to perform and training will take part during regularly scheduled training sessions.

Device: Multiplanar neuromuscular training

Interventions

See arm description

Also known as: TopSpin360 training
multiplanar neuromuscular training arm

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Healthy adults on Western University's women's soccer and rugby teams

You may not qualify if:

  • those who are not medically cleared to participate in out of season training, or anyone under the age of 18

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Western University

London, Ontario, N6A3K7, Canada

Location

Related Publications (2)

  • Versteegh T, Beaudet D, Greenbaum M, Hellyer L, Tritton A, Walton D. Evaluating the reliability of a novel neck-strength assessment protocol for healthy adults using self-generated resistance with a hand-held dynamometer. Physiother Can. 2015 Winter;67(1):58-64. doi: 10.3138/ptc.2013-66.

    PMID: 25931654BACKGROUND
  • Tong HC, Haig AJ, Yamakawa K. The Spurling test and cervical radiculopathy. Spine (Phila Pa 1976). 2002 Jan 15;27(2):156-9. doi: 10.1097/00007632-200201150-00007.

    PMID: 11805661BACKGROUND

Study Officials

  • David M Walton, PhD

    Western University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Model Details: This project will recruit 60 healthy players from Western University's women's soccer and rugby teams. In addition to the team's standard out-of-season baseline testing, participants will have their height, weight, dynamic and static neck strength, neck circumference and 40-yard dash times assessed at baseline. Players will be invited to participate in a 12-week neuromuscular strength training program using the TopSpin360 neuromuscular neck training device. This program will be supervised by a member of the research team 3 days per week in addition to their out-of-season standard training program that does not currently include any exercise specific to the muscles of the neck. Upon completion of the 12 week TopSpin360 training program the study participants will have their weight, neck circumference, dynamic and static neck strength and 40-yard dash times re-assessed.
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 12, 2019

First Posted

February 18, 2019

Study Start

March 1, 2019

Primary Completion

June 30, 2023

Study Completion

June 30, 2023

Last Updated

May 14, 2025

Record last verified: 2025-05

Data Sharing

IPD Sharing
Will not share

Locations