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TopSpin360 in Female Varsity Athletes

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT03844087
Recruitment Status : Active, not recruiting
First Posted : February 18, 2019
Last Update Posted : October 12, 2021
Information provided by (Responsible Party):
TopSpin Technologies Ltd

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.

Condition or disease Intervention/treatment Phase
Neuromuscular Strength Training Device: Multiplanar neuromuscular training Phase 1 Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: 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.
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Effect of Training on the TopSpin360 on Neck Strength and 40-yard Dash Times in Female Varsity Level Athletes
Actual Study Start Date : March 1, 2019
Actual Primary Completion Date : June 30, 2021
Estimated Study Completion Date : February 2022

Arm Intervention/treatment
Experimental: multiplanar neuromuscular training arm
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
See arm description
Other Name: TopSpin360 training

Primary Outcome Measures :
  1. Change in static neck strength as measured using a handheld dynamometer [ Time Frame: Change from Baseline Static Neck Strength after 12 weeks of training ]
    Multiplanar static neck strength

  2. Change in Dynamic neck strength [ Time Frame: Change from Baseline Performance in Dynamic Neck Strength after12 weeks of training ]
    Performance on the TopSpin360

  3. Change in 40 yard dash time [ Time Frame: Change from Baseline 40 yard dash time after 12 weeks of training ]
    time to sprint 40 yards

Secondary Outcome Measures :
  1. Change in Neck girth [ Time Frame: Change in Neck Girth after 12 weeks of training ]
    neck girth measurement

  2. Relationship between self-declared concussion history and static and neck strength [ Time Frame: As measured at Baseline ]
    Independent t-tests between average static and dynamic neck strength of those with a history of concussion compared to the average static and dynamic neck strength of those without a history of concussion

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

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

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03844087

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Canada, Ontario
Western University
London, Ontario, Canada, N6A3K7
Sponsors and Collaborators
TopSpin Technologies Ltd
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Principal Investigator: David M Walton, PhD Western University
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Responsible Party: TopSpin Technologies Ltd Identifier: NCT03844087    
Other Study ID Numbers: 112841
First Posted: February 18, 2019    Key Record Dates
Last Update Posted: October 12, 2021
Last Verified: October 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by TopSpin Technologies Ltd:
multiplanar, plyometric, neck strength