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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04213560
Other study ID # 545-2016-2017
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date December 15, 2016
Est. completion date December 31, 2018

Study information

Verified date January 2024
Source VA Puget Sound Health Care System
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Purposes: 1) To determine the effects of weighted waist-hooping on balance in healthy individuals and 2) to observe whether these effects are attributed to neuromuscular conditioning or core strength gains. Methods: 27 females (ages 20-45) were included, 15 in the intervention group, and 12 in the control. The intervention consisted of six weeks of weighted waist-hooping four times a week for 10 minutes each session. Balance was assessed pre and post intervention using the BESS, SEBT, and Neurocom SOT. Core strength was assessed using hold duration of a bilateral and unilateral plank.


Recruitment information / eligibility

Status Completed
Enrollment 27
Est. completion date December 31, 2018
Est. primary completion date December 31, 2018
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years to 45 Years
Eligibility Inclusion Criteria: - healthy women age 18-45. Exclusion Criteria: - pregnancy and vertigo

Study Design


Related Conditions & MeSH terms


Intervention

Device:
weighted waist-hooping
weighted waist-hooping

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
The Sage Colleges

Outcome

Type Measure Description Time frame Safety issue
Primary Balance Error Scoring System (BESS) Participants were instructed to maintain each of the 6 positions for as long as possible and to continue to try until the 20 seconds were complete even if balance was lost, which was counted as an error along with the specific error criteria for this assessment. Total number of errors were recorded for each position according and the summated to provide a total error score. A higher score indicates greater occurrence of error and thus poorer balance. baseline
Primary Balance Error Scoring System (BESS) Participants were instructed to maintain each of the 6 positions for as long as possible and to continue to try until the 20 seconds were complete even if balance was lost, which was counted as an error along with the specific error criteria for this assessment. Total number of errors were recorded for each position according and the summated to provide a total error score. A higher score indicates greater occurrence of error and thus poorer balance. 6 - weeks
Primary Star Excursion Balance Test (SEBT) SEBT was conducted for both the right and left leg reaching. Position on the start was used to indicate where to reach. Reaching across the body with the right foot to the left side and reaching across the body with the left foot to the right side were both defined as a medial reach for the purpose of this study. baseline
Primary Star Excursion Balance Test (SEBT) SEBT was conducted for both the right and left leg reaching. Position on the start was used to indicate where to reach. Reaching across the body with the right foot to the left side and reaching across the body with the left foot to the right side were both defined as a medial reach for the purpose of this study. 6 - weeks
Primary equilibrium scores (EQ scores) of the Sensory Organization Test (SOT) on the NeuroCom The SOT parses out contributions and functionality of the visual, somatosensory, and vestibular systems provide information regarding the effects of each system on postural control.8 The EQ score is a composite score calculated by the NeuroCom by weighting each of the 6 conditions of typical and altered stimuli. A score closer to 100 indicates less postural sway and a score closer to 0 indicates more postural sway and increased likelihood of fall.8 An increase in EQ score indicates an improvement in postural control and potentially sensory selection since the purpose of the SOT is to determine if patients are able to appropriately reweight their senses in response to the six different conditions in an effort to maintain postural control. baseline
Primary equilibrium scores (EQ scores) of the Sensory Organization Test (SOT) on the NeuroCom The SOT parses out contributions and functionality of the visual, somatosensory, and vestibular systems provide information regarding the effects of each system on postural control.8 The EQ score is a composite score calculated by the NeuroCom by weighting each of the 6 conditions of typical and altered stimuli. A score closer to 100 indicates less postural sway and a score closer to 0 indicates more postural sway and increased likelihood of fall.8 An increase in EQ score indicates an improvement in postural control and potentially sensory selection since the purpose of the SOT is to determine if patients are able to appropriately reweight their senses in response to the six different conditions in an effort to maintain postural control. 6 - weeks
Primary Core Strength position 1 hold a standard bilateral plank position to assess core strength. The duration of time the participant was able to hold each position was recorded. If the participant was unable to attain proper form or unable to complete the task the duration of hold was recorded as 0 seconds. These assessments were conducted before and after the weighted waist-hooping intervention. baseline
Primary Core Strength position 1 hold a standard bilateral plank position to assess core strength. The duration of time the participant was able to hold each position was recorded. If the participant was unable to attain proper form or unable to complete the task the duration of hold was recorded as 0 seconds. These assessments were conducted before and after the weighted waist-hooping intervention. 6 - weeks
Primary Core Strength position 2 hold a unilateral plank with the dominant leg raised position to assess core strength. The duration of time the participant was able to hold the position was recorded. If the participant was unable to attain proper form or unable to complete the task the duration of hold was recorded as 0 seconds. These assessments were conducted before and after the weighted waist-hooping intervention. baseline
Primary Core Strength position 2 hold a unilateral plank with the dominant leg raised position to assess core strength. The duration of time the participant was able to hold the position was recorded. If the participant was unable to attain proper form or unable to complete the task the duration of hold was recorded as 0 seconds. These assessments were conducted before and after the weighted waist-hooping intervention. 6 - weeks
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