NCT05570890

Brief 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.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

Study Start

First participant enrolled

April 29, 2022

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

August 14, 2022

Completed
2 months until next milestone

First Posted

Study publicly available on registry

October 7, 2022

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2022

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2023

Completed
Last Updated

October 7, 2022

Status Verified

July 1, 2022

Enrollment Period

7 months

First QC Date

August 14, 2022

Last Update Submit

October 6, 2022

Conditions

BalancedElectroencephalographyElectromyography

Keywords

Center of pressureElectroencephalographyElectromyographyH reflexElectrical noise stimulation

Outcome Measures

Primary Outcomes (5)

  • Mean sway path of the center of pressure

    The mean sway path in mm will represent balance performance

    40 seconds under each condition

  • Mean sway velocity of the center of pressure

    The mean sway velocity in mm/sec will represent balance performance

    40 seconds under each condition

  • Cortical excitability

    Power spectrum density of EEG will calculated for representing cortical excitability.

    40 seconds under each condition

  • Spinal reflex excitability

    H reflex amplitude will represent the excitability of peripheral control from spinal level nerve system.

    40 seconds under each condition

  • 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

Study Arms (4)

Sham stimulation on stable surface

EXPERIMENTAL

The participant will not receive stimulation and will stand on flat ground.

Device: Sham stimulation

Noise stimulation on stable surface

EXPERIMENTAL

The participant will receive stimulation with intensity set at 90% of their sensory threshold and will stand on flat ground.

Device: electrical noise stimulation

Sham stimulation on unstable surface

EXPERIMENTAL

The participant will not receive stimulation and will stand on foam.

Device: Sham stimulationDevice: Foam

Noise stimulation on unstable surface

EXPERIMENTAL

The participant will receive stimulation with intensity set at 90% of their sensory threshold and will stand on foam.

Device: electrical noise stimulationDevice: Foam

Interventions

electrical noise stimulationDEVICE

The intensity of electrical noise stimulation will be set at 90% of the sensory threshold of each participant.

Noise stimulation on stable surfaceNoise stimulation on unstable surface
Sham stimulationDEVICE

Participants will not receive stimulation.

Sham stimulation on stable surfaceSham stimulation on unstable surface
FoamDEVICE

The foam will be used to make an unstable surface.

Noise stimulation on unstable surfaceSham stimulation on unstable surface

Eligibility Criteria

Age20 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • subject who cannot tolerate the cutaneous electrical stimulation to induce H reflex
  • single-leg stance (SLS) without support is shorter than 80 secs

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Yang-Ming University

Taipei, 112, Taiwan

Location

MeSH Terms

Interventions

Transcranial Direct Current StimulationVaginal Creams, Foams, and Jellies

Intervention Hierarchy (Ancestors)

Electric Stimulation TherapyTherapeuticsConvulsive TherapyPsychiatric Somatic TherapiesBehavioral Disciplines and ActivitiesElectroshockPsychological TechniquesDosage FormsPharmaceutical PreparationsFeminine Hygiene ProductsEquipment and Supplies

Study Officials

  • Li-Wei Chou, PhD

    National Yang Ming Chiao Tung University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
The stimulation intensity is set under the sensory threshold, therefore participants will be masked in the study.
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 14, 2022

First Posted

October 7, 2022

Study Start

April 29, 2022

Primary Completion

November 30, 2022

Study Completion

January 31, 2023

Last Updated

October 7, 2022

Record last verified: 2022-07

Data Sharing

IPD Sharing
Will not share

The informed Consent Form used in this research does not mention IPD sharing.

Locations

TW(1)