NCT04785079

Brief Summary

This study is designed to evaluate the short term change in blood flow in the superficial human tissue layers after the application of 3 min Graston instrumented assisted soft tissue mobilization on the plantar aspect of the foot and the trapezius muscle.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
35

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2020

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

Study Start

First participant enrolled

August 1, 2020

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

March 1, 2021

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 5, 2021

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2022

Completed
Last Updated

July 27, 2022

Status Verified

July 1, 2022

Enrollment Period

1.6 years

First QC Date

March 1, 2021

Last Update Submit

July 26, 2022

Conditions

Asymptomatic Condition

Keywords

Instrument assisted soft tissue mobilizationMusculoskeletal Ultrasound ImagingBood circulationPerception

Outcome Measures

Primary Outcomes (1)

  • GE LOGIQe ultrasound machine to measure maximum power doppler imaging quantification (PDIQ) ratios

    ultrasound images are used to calculate the ratio of color to grey scale pixels called the power doppler quantification ratio (PDIQ).

    One day measure-First measure will be taken before the treatment intervention, immediate after the intervention and three minutes afterward. Total time for the experiment is 15 minutes

Study Arms (1)

Graston effect medial arch, plantar fascia, and trapezius

EXPERIMENTAL

Pre and post Graston change in blood flow at the medial arch foot, plantar fascia, and the trapezius region

Procedure: Graston Instrument assisted Soft tissue Mobilization

Interventions

Graston Instrument assisted Soft tissue MobilizationPROCEDURE

Instrument assisted soft tissue mobilization using the Graston tool and technique for 3 minutes on each of the three locations

Graston effect medial arch, plantar fascia, and trapezius

Eligibility Criteria

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

You may qualify if:

  • A-symptomatic individuals over the age of 18

You may not qualify if:

  • Anyone under 18 and anyone with any conditions contraindicated for IASTM including compromised tissue integrity, deep vein thrombosis (DVT), area of infection in the treatment area, or acute fracture.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Florida Gulf Coast University

Fort Myers, Florida, 33965, United States

Location

MeSH Terms

Conditions

Asymptomatic Diseases

Condition Hierarchy (Ancestors)

Disease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: Quasi-experimental study using a single group
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistent Professor

Study Record Dates

First Submitted

March 1, 2021

First Posted

March 5, 2021

Study Start

August 1, 2020

Primary Completion

March 1, 2022

Study Completion

March 1, 2022

Last Updated

July 27, 2022

Record last verified: 2022-07

Data Sharing

IPD Sharing
Will not share

Locations

US(1)