HealthyNCT05445622
Assessing Student Learning of Spinal Mobilization With Real-time Objective Feedback
A study testing learning spinal mobilization with a force sensor in people with Healthy, run by Youngstown State University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- learning spinal mobilization with a force sensor
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Apr 2019to 10 Aug 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Second year Physical Therapy students; males or females; age between 20 and 60 years of age.
Who cannot join
- Student who is not a second year Physical Therapy student or unwilling to participate in the study.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Healthy
- Being tested
- learning spinal mobilization with a force sensor
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
learning spinal mobilization with a force sensorOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: learning spinal mobilization with a force sensor |
| Control | Active comparator | Subjects were taught spinal mobilization using the traditional approach. Receives: Other: learning spinal mobilization with a force sensor |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: immediately after the intervention/procedure
Secondary outcomes (1)
Student mobilization skill
Assessed by instructor on 0-10 scale (10 being a satisfactory and 0 being not satisfactory)
Measured: immediately after the intervention/procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2022
- Study start10 Apr 2019
- Primary completion10 May 2019
- Study completion10 Aug 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Youngstown State University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Weiqing Ge, DPT, PhD, Principal investigator, Youngstown State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05445622
- Sponsor's protocol ID
- 174-19
- Status last verified
- Jul 2022
- First submitted
- 14 Feb 2022
- Last updated
- 6 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing Student Learning of Spinal Mobilization With Real-time Objective Feedback
- ClinicalTrials.gov ID
- NCT05445622
- Acronym / sponsor ID
- 174-19
- Conditions
- Healthy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Youngstown State UniversityUniversity, hospital or other
- Study start
- 10 Apr 2019 (actual)
- Primary completion
- 10 May 2019 (actual)
- Study completion
- 10 Aug 2019 (actual)
- First posted
- 6 Jul 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental | Experimental | Other: learning spinal mobilization with a force sensorSubjects 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. |
| Control | Active comparator | Other: learning spinal mobilization with a force sensorSubjects were taught spinal mobilization using the traditional approach. |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Second year Physical Therapy students; males or females; age between 20 and 60 years of age.
Key exclusion criteria (1 listed)
- Student who is not a second year Physical Therapy student or unwilling to participate in the study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| learning spinal mobilization with a force sensorExperimental 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. | Other | Control, Experimental |
Primary outcome
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)
1 secondary outcome
Student mobilization skill
Time frame: immediately after the intervention/procedure
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jul 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Weiqing Ge, DPT, PhD principal investigator
Youngstown State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing learning spinal mobilization with a force sensor in people with Healthy, run by Youngstown State University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jul 2022.