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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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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

Other trials in United States

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 groups in NCT04712695
Study groupRoleWhat they receive
Graded Motor Imagery GroupExperimentalNot described
Receives: Other: Exercise Based Interventions
Mirror Visual Feedback GroupExperimentalNot described
Receives: Other: Exercise Based Interventions
Augmented Biofeedback GroupExperimentalNot described
Receives: Other: Exercise Based Interventions
Diaphragmatic Breathing GroupSham comparatorNot described
Receives: Other: Exercise Based Interventions

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

  1. First posted15 Jan 2021
  2. Study start3 Feb 2020
  3. Primary completion10 Nov 2020
  4. Study completion10 Nov 2020

Resources

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)
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

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.

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