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Clinical Trial Details — Status: Enrolling by invitation

Administrative data

NCT number NCT05570890
Other study ID # YM111060E
Secondary ID
Status Enrolling by invitation
Phase N/A
First received
Last updated
Start date April 29, 2022
Est. completion date January 31, 2023

Study information

Verified date July 2022
Source National Yang Ming University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Noise stimulation had an immediate effect on improving balance control. The present study aimed to clarify the immediate neuromuscular adaptation induced by noise stimulation and find the correlation between neuromuscular adaptation and functional performance.


Description:

The mechanism behind noise stimulation is called Stochastic Resonance which improves the detectivity of sensory input with the presence of noise, making sub-sensory threshold input detectable. Noise stimulation had been proved to improve postural control, Ia afferent sensitivity, and muscle activity of the tibialis anterior. With this evidence of the effect of noise stimulation on balance enhancement, the neuromuscular adaptation induced by noise stimulation has not been researched yet. Therefore, the present study aims to clarify the immediate effect of noise on neuromuscular regulation during postural control.


Recruitment information / eligibility

Status Enrolling by invitation
Enrollment 20
Est. completion date January 31, 2023
Est. primary completion date November 30, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 20 Years to 40 Years
Eligibility Inclusion Criteria: - age between 20 and 40 years old - without ankle injury history in 1 year - without musculoskeletal or neurological diseases that would affect balance performance - without visual impairment (except vision correction or no visual problems) - without vestibular impairment. Exclusion Criteria: - subject who cannot tolerate the cutaneous electrical stimulation to induce H reflex - single-leg stance (SLS) without support is shorter than 80 secs

Study Design


Related Conditions & MeSH terms


Intervention

Device:
electrical noise stimulation
The intensity of electrical noise stimulation will be set at 90% of the sensory threshold of each participant.
Sham stimulation
Participants will not receive stimulation.
Foam
The foam will be used to make an unstable surface.

Locations

Country Name City State
Taiwan National Yang-Ming University Taipei

Sponsors (1)

Lead Sponsor Collaborator
National Yang Ming University

Country where clinical trial is conducted

Taiwan, 

Outcome

Type Measure Description Time frame Safety issue
Primary Mean sway path of the center of pressure The mean sway path in mm will represent balance performance 40 seconds under each condition
Primary Mean sway velocity of the center of pressure The mean sway velocity in mm/sec will represent balance performance 40 seconds under each condition
Primary Cortical excitability Power spectrum density of EEG will calculated for representing cortical excitability. 40 seconds under each condition
Primary Spinal reflex excitability H reflex amplitude will represent the excitability of peripheral control from spinal level nerve system. 40 seconds under each condition
Primary Co-activation index Co-activation index will be calculated by EMG activity of Tibialis Anterior and Soleus muscle to represent the muscle activity. 40 seconds after each condition
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