NCT05445622

Brief Summary

This is a research project on physical therapy education. Subjects will be recruited using convenience sampling from second-year physical therapy students on the campus of Youngstown State University. There are currently 28 students in the class. All students will be recruited to participate in the study. The objective of the study is to assess student learning of grades of spinal mobilization with real-time objective feedback.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
28

participants targeted

Target at P25-P50 for not_applicable healthy

Timeline
Completed

Started Apr 2019

Shorter than P25 for not_applicable healthy

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

April 10, 2019

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 10, 2019

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 10, 2019

Completed
2.5 years until next milestone

First Submitted

Initial submission to the registry

February 14, 2022

Completed
5 months until next milestone

First Posted

Study publicly available on registry

July 6, 2022

Completed
Last Updated

July 6, 2022

Status Verified

July 1, 2022

Enrollment Period

1 month

First QC Date

February 14, 2022

Last Update Submit

July 5, 2022

Conditions

Outcome Measures

Primary Outcomes (1)

  • A perceived competence scale survey instructor will serve as the assessor of student skill level to avoid bias. Student t test will be used for data analysis. Perceived competence scale survey

    A self reporting survey (score between 0-10 with 10 being confident and 0 being not confident)

    immediately after the intervention/procedure

Secondary Outcomes (1)

  • Student mobilization skill

    immediately after the intervention/procedure

Study Arms (2)

Experimental

EXPERIMENTAL

Subjects were able to practice spinal manipulation using the Activ5 device (Activbody, San Diego, CA, USA) for real-time objective visual feedback during in class lecture and lab. Activ5 device has a built-in force sensor that can provide realtime objective visual feedback via a Bluetooth connected mobile device.

Other: learning spinal mobilization with a force sensor

Control

ACTIVE COMPARATOR

Subjects were taught spinal mobilization using the traditional approach.

Other: learning spinal mobilization with a force sensor

Interventions

Experimental group will use a force sensor (Active5) while learning spinal mobilization during the practice lab portion of the class. The force sensor will provide objective feedback to the students. Each student will be instructed on how to use the Active 5 device prior to utilization it in the classroom setting.

ControlExperimental

Eligibility Criteria

Age20 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Second year Physical Therapy students; males or females; age between 20 and 60 years of age.

You may not qualify if:

  • Student who is not a second year Physical Therapy student or unwilling to participate in the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Youngstown State University

Youngstown, Ohio, 44555, United States

Location

Study Officials

  • Weiqing Ge, DPT, PhD

    Youngstown State University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 14, 2022

First Posted

July 6, 2022

Study Start

April 10, 2019

Primary Completion

May 10, 2019

Study Completion

August 10, 2019

Last Updated

July 6, 2022

Record last verified: 2022-07

Data Sharing

IPD Sharing
Will not share

Locations