- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05445622
Assessing Student Learning of Spinal Mobilization With Real-time Objective Feedback
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Sampling: Subjects will be recruited using convenience sampling from second-year physical therapy students on the campus of Youngstown State University.
Research Design: Randomized controlled trial (RCT). Subjects will be randomly assigned to the experimental group or control group. Subjects will attend a spinal mobilization lecture followed by a practice lab.
Randomization: Once enrolled in the study, each student will be randomly assigned to experimental or control groups. Randomization will occur via a random number generator and allocation will be concealed in opaque envelopes.
Intervention:
The 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 utilizing it in the classroom setting. The device can display the amount of force generated by the student on a smartphone or a tablet in real-time so the students would be able to adjust the amount of force.
The Control group will participate in the same classroom lecture and activity. However, during the practice lab portion of the class, the control group will only receive traditional subjective feedback from the class instructor and/or student peers.
A perceived competence scale survey (score between 0-10 with 10 being confident and 0 being not confident) with demographic information will be administered immediately after the intervention. An independent blinded instructor will serve as the assessor of student skill level to avoid bias immediately after the intervention/procedure. Student t-test will be used for data analysis.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Ohio
-
Youngstown, Ohio, United States, 44555
- Youngstown State University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Second year Physical Therapy students; males or females; age between 20 and 60 years of age.
Exclusion Criteria:
- Student who is not a second year Physical Therapy student or unwilling to participate in the study.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
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.
|
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.
|
|
Active Comparator: Control
Subjects were taught spinal mobilization using the traditional approach.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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
Time Frame: immediately after the intervention/procedure
|
A self reporting survey (score between 0-10 with 10 being confident and 0 being not confident)
|
immediately after the intervention/procedure
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Student mobilization skill
Time Frame: immediately after the intervention/procedure
|
Assessed by instructor on 0-10 scale (10 being a satisfactory and 0 being not satisfactory)
|
immediately after the intervention/procedure
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Weiqing Ge, DPT, PhD, Youngstown State University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 174-19
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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