NCT03023943

Brief Summary

The research design will be single group pretest-posttest design. The subject will be instructed to position the knee joint to a position previously set by the experimenter. Intervention will be 10 minutes of GT1 instrument application at anterior thigh using sweep technique.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at P25-P50 for not_applicable healthy-volunteers

Timeline
Completed

Started Feb 2017

Typical duration for not_applicable healthy-volunteers

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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 11, 2017

Completed
7 days until next milestone

First Posted

Study publicly available on registry

January 18, 2017

Completed
16 days until next milestone

Study Start

First participant enrolled

February 3, 2017

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2018

Completed
Last Updated

January 10, 2020

Status Verified

January 1, 2020

Enrollment Period

1.3 years

First QC Date

January 11, 2017

Last Update Submit

January 7, 2020

Conditions

Healthy Volunteers

Outcome Measures

Primary Outcomes (1)

  • Proprioception determined using the reposition error

    Proprioception will be determined by measuring the reposition error of the knee joint. The subject will be instructed to position the knee joint to a position (flexion) previously set by the experimenter at 30 degree flexion. The difference will be calculated as the reposition error. The position of the knee joint will be measure using a goniometer. An alternative is to use an App (e.g. Angle Meter) on a smart phone or an iPad for accuracy.

    5 minutes

Study Arms (1)

IASTM group

EXPERIMENTAL

Intervention will be 10 minutes of GT1 instrument application at anterior thigh using sweep technique.

Other: Instrument Assisted Soft Tissue Mobilization

Interventions

Instrument Assisted Soft Tissue MobilizationOTHER

Intervention will be 10 minutes of GT1 instrument application at anterior thigh using sweep technique.

Also known as: IASTM
IASTM group

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • male or female, age 18 to 65.

You may not qualify if:

  • sensory impairments or a present contraindications to IASTM which include cancer, burn scars, kidney dysfunction, pregnancy, varicose veins, osteoporosis, body art, chronic regional pain syndrome, polyneuropathies, fractures, autoimmune disorders, diabetes, vitamin C \& D/Calcium deficiencies, rheumatoid arthritis, ankylosing spondylitis, congestive heart failure, acute inflammation, lymphedema, flu or illness with flu-like symptoms, and medications (anticoagulant, steroids, hormone replacements, NSAIDS, fluoroquinolone antibiotics, herbal supplements).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Youngstown State University

Youngstown, Ohio, 44555, United States

Location

Study Officials

  • Michael Hripko

    Youngstown State University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

January 11, 2017

First Posted

January 18, 2017

Study Start

February 3, 2017

Primary Completion

May 31, 2018

Study Completion

May 31, 2018

Last Updated

January 10, 2020

Record last verified: 2020-01

Locations

US(1)