NCT01862393

Brief Summary

This study aims to examine the variation in muscle torque and discomfort produced when electrically stimulating quadriceps femoris using pulsed current with three different phase durations in order to establish whether there are any advantages or disadvantages in varying the phase duration over the range examined.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
38

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2008

Shorter than P25 for not_applicable

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

Study Start

First participant enrolled

August 1, 2008

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2008

Completed
4.5 years until next milestone

First Submitted

Initial submission to the registry

May 17, 2013

Completed
7 days until next milestone

First Posted

Study publicly available on registry

May 24, 2013

Completed
Last Updated

September 1, 2016

Status Verified

August 1, 2016

Enrollment Period

4 months

First QC Date

May 17, 2013

Last Update Submit

August 31, 2016

Conditions

TorquePain Perception

Keywords

electrical stimulationtorque

Outcome Measures

Primary Outcomes (1)

  • Torque

    Torque will be measured using an isokinetic dynamometer. Torque will be registered in Newton meter \[N.m\]

    During 4 seconds of electrical stimulation

Secondary Outcomes (1)

  • Discomfort

    During 6 seconds of electrical stimulation

Study Arms (3)

400 microseconds

EXPERIMENTAL

Electrically-induced torque generated with stimulus phase duration set at 400 microseconds.

Device: 400 microseconds

700 microseconds

EXPERIMENTAL

Electrically-induced torque generated with stimulus phase duration set at 700 microseconds.

Device: 700 microseconds

1000 microseconds

EXPERIMENTAL

Electrically-induced torque generated with stimulus phase duration set at 1000 microseconds.

Device: 1000 microseconds

Interventions

400 microsecondsDEVICE

Neuromuscular electrical stimulation with stimulus phase duration of 400 microseconds

400 microseconds
700 microsecondsDEVICE

Neuromuscular electrical stimulation with stimulus phase duration of 700 microseconds

700 microseconds
1000 microsecondsDEVICE

Neuromuscular electrical stimulation with stimulus phase duration of 1000 microseconds

1000 microseconds

Eligibility Criteria

Age18 Years - 35 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • sedentary healthy university students.

You may not qualify if:

  • history of knee surgery or injury,
  • musculoskeletal, cardiovascular or neurological disease including impaired sensation.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Universidade Cidade de São Paulo

São Paulo, São Paulo, 03071-000, Brazil

Location

Study Officials

  • Richard E Liebano, PhD

    Universidade Cidade de Sao Paulo

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

May 17, 2013

First Posted

May 24, 2013

Study Start

August 1, 2008

Primary Completion

December 1, 2008

Study Completion

December 1, 2008

Last Updated

September 1, 2016

Record last verified: 2016-08

Locations

BR(1)