ProprioceptionNCT04712695
Comparing the Effectiveness of Various Interventions on Improving Lumbar Proprioception
A study testing Exercise Based Interventions in people with Proprioception, run by Black Hills State University at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Proprioception
- What is being tested?
- Exercise Based Interventions
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Feb 2020to 10 Nov 2020
- 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 18 to 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy university students ages 18-35
- Must be able to perform low intensity exercise
Who cannot join
- Past medical history of back surgery
- Back pain within the past 6 months
- Musculoskeletal injury within the past 6 months
Trial locations and contacts
1 site in 1 country.
United States1 site
Black Hills State University
Spearfish, South Dakota, 57783-9575
About this study
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.
Read more
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
- Conditions
- Proprioception
- Being tested
- Exercise Based Interventions
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exercise Based InterventionsOther
Proprioception Training Interventions
| Study group | Role | What they receive |
|---|---|---|
| Graded Motor Imagery Group | Experimental | Not described Receives: Other: Exercise Based Interventions |
| Mirror Visual Feedback Group | Experimental | Not described Receives: Other: Exercise Based Interventions |
| Augmented Biofeedback Group | Experimental | Not described Receives: Other: Exercise Based Interventions |
| Diaphragmatic Breathing Group | Sham comparator | Not described Receives: Other: Exercise Based Interventions |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proprioception
Change in lumbar proprioception as assessed through the seated forward flexion test measured in cm following a single training session.
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jan 2021
- Study start3 Feb 2020
- Primary completion10 Nov 2020
- Study completion10 Nov 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ProprioceptionStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Black Hills State University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Craig Triplett, Black Hills State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04712695
- Sponsor's protocol ID
- BlackHillsSU
- Status last verified
- Jan 2021
- First submitted
- 12 Jan 2021
- Last updated
- 19 Jan 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 19 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparing the Effectiveness of Various Interventions on Improving Lumbar Proprioception
- ClinicalTrials.gov ID
- NCT04712695
- Acronym / sponsor ID
- BlackHillsSU
- Conditions
- Proprioception
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Black Hills State UniversityUniversity, hospital or other
- Study start
- 3 Feb 2020 (actual)
- Primary completion
- 10 Nov 2020 (actual)
- Study completion
- 10 Nov 2020 (actual)
- First posted
- 15 Jan 2021 (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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Graded Motor Imagery Group | Experimental | Other: Exercise Based Interventions |
| Mirror Visual Feedback Group | Experimental | Other: Exercise Based Interventions |
| Augmented Biofeedback Group | Experimental | Other: Exercise Based Interventions |
| Diaphragmatic Breathing Group | Sham comparator | Other: Exercise Based Interventions |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Healthy university students ages 18-35
- Must be able to perform low intensity exercise
Key exclusion criteria (3 listed)
- Past medical history of back surgery
- Back pain within the past 6 months
- Musculoskeletal injury within the past 6 months
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 |
|---|---|---|
| Exercise Based InterventionsProprioception Training Interventions | Other | Augmented Biofeedback Group, Diaphragmatic Breathing Group, Graded Motor Imagery Group, Mirror Visual Feedback Group |
Primary outcome
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.
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 19 Jan 2021.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise Based Interventions in people with Proprioception, run by Black Hills 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 2 inclusion and 3 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 19 Jan 2021. 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. Some participants in this study may receive a placebo. 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?
Proprioception (time frame: Day 1). 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 19 Jan 2021.