- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04712695
Comparing the Effectiveness of Various Interventions on Improving Lumbar Proprioception
University students ages 18-45, with no recent history of back injury and no history of back surgery, were recruited. Participants completed proprioception testing consisting of a standing side bending and seated spinal flexion test. Participants performed each test once, then were blindfolded and asked to replicate the tests 10 times. After the initial proprioceptive testing, the participants were randomly split into four groups and performed a 10-minute intervention exercise, before repeating the proprioceptive tests for final measurements. The four groups included: graded motor imagery, mirror visual feedback, augmented biofeedback, and diaphragmatic breathing. Participants also completed a Physical Activity Enjoyment Scale to rate their enjoyment of their intervention task
-For the seated forward flexion test, the participants' C7 and S2 vertebrae were identified and used as markers. The participants were asked to bend forward until the tape measure increased 5 cm from the original distance between the C7 and S2 vertebrae. Similar to the seated flexion test, during the side-bending task, the participants were asked to side bend until the tip of their middle finger was 10 cm closer to the floor. The participants were asked to memorize that point in their mind; they were then blindfolded and asked to repeat the movement 10 times, trying to recreate the original position to the best of their ability.
Between initial and final measurements of proprioception, the participants were randomly assigned to one of the following four groups for interventions for a 10-minute training session:
- Graded Motor Imagery Group: Participants were shown several flashcards with pictures of individuals' back oriented to either the flexed or side bent position. The participants stated which direction the image depicted and visualized themselves making the movement identified in the picture.
- Mirror Visual Feedback Group:
Participants viewed themselves in a mirror while performing flexion and side bending movements.
-Augmented Biofeedback Group: Participants used an augmented musculoskeletal feedback system smartphone application app and small sensors with Bluetooth technology to translate the movement of the participant into an avatar on the game.
-Diaphragmatic Breathing Group: Participants were told to sit on a chair with their back straight and feet flat on the floor with one hand on their chest and one hand on their stomach. They performed diaphragmatic breathing in a slow 4 second box method: breathing in for 4 seconds, holding for 4 seconds, breathing out for 4 seconds, and then hold for 4 seconds
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
South Dakota
-
Spearfish, South Dakota, United States, 57783-9575
- Black Hills State University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Healthy university students ages 18-35
- Must be able to perform low intensity exercise
Exclusion Criteria:
- Past medical history of back surgery
- Back pain within the past 6 months
- Musculoskeletal injury within the past 6 months
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Graded Motor Imagery Group
|
Proprioception Training Interventions
|
Experimental: Mirror Visual Feedback Group
|
Proprioception Training Interventions
|
Experimental: Augmented Biofeedback Group
|
Proprioception Training Interventions
|
Sham Comparator: Diaphragmatic Breathing Group
|
Proprioception Training Interventions
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Proprioception
Time Frame: Day 1
|
Change in lumbar proprioception as assessed through the seated forward flexion test measured in cm following a single training session.
|
Day 1
|
Collaborators and Investigators
Sponsor
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
- BlackHillsSU
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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