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ExercisePNFNCT06667115

Proprioceptive Neuromuscular Facilitation Exercise on Early Shoulder Muscle Activation in Healthy Individuals

A study testing PNF exercise, PNF exercise with virtual reality gaming and PNF with concurrent feedback in people with Exercise and Healthy, run by Dominican University New York 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

The study explores the effect of proprioceptive neuromuscular facilitation (PNF) exercises combined with virtual reality (VR) motion capture system and concurrent feedback (CF), on early shoulder muscle activation in healthy individuals. Read more about this study

Who is it for?
Ages 18 to 45 yearsHealthy volunteers can take part
Conditions the study is for
Exercise, Healthy
What is being tested?
PNF exercise, PNF exercise with virtual reality gaming and PNF with concurrent feedback
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
1 siteUnited States
Study dates
30 Apr 2023to 30 Dec 2023
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 45 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • being 18-45 years old
  • capable of performing PNF D2 shoulder flexion exercise

Who cannot join

  • any shoulder injuries in the dominant arm within the last 3 months
  • pain in the scapular region
  • rotator cuff tear or reconstruction
  • shoulder dislocation
  • shoulder instability
  • frozen shoulder
  • fracture
  • chronic neck pain

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Dominican University New York, Doctor of Physical Therapy Program

    Orangeburg, New York, 10962

Other trials in United States

About this study

Official title: The Effectiveness of Proprioceptive Neuromuscular Facilitation Exercise With Virtual Reality Motion Capture Gaming System and Concurrent Feedback on Early Shoulder Muscle Activation in Healthy Individuals

The study explores the effect of proprioceptive neuromuscular facilitation (PNF) exercises combined with virtual reality (VR) motion capture system and concurrent feedback (CF), on early shoulder muscle activation in healthy individuals. Thirty healthy individuals performed three PNF D2 shoulder exercises sequentially: first PNF alone, then PNF with VR (using U-Ball game (BeCure Global Inc.) on Xbox Kinect (PNF+VR), and PNF with VR and CF (PNF+VR+CF), with the latter two in a randomized order. Using wireless surface electromyography (EMG) and 3D inertial measurement units (Noraxon USA, Inc.), the activation of the upper trapezius (UT), lower trapezius (LT), infraspinatus (INF), and serratus anterior muscles (SA), along with shoulder flexion, abduction, and external rotation range of motion were recorded during three shoulder exercises.

Read the detailed description

Study Design A one-way repeated measures design was employed to investigate the potential benefits of augmenting PNF exercises with VR and concurrent feedback for enhancing early shoulder muscle activation in healthy individuals.

Participants Thirty healthy volunteers (14 males and 16 females with an average age of 26.2 ± 4 years) were recruited through convenience sampling. The inclusion criteria required being 18-45 years old and capable of performing PNF D2 shoulder flexion exercise. Exclusion criteria, designed to ensure sample homogeneity and data reliability, included any shoulder injuries in the dominant arm within the last 3 months, such as pain in the scapular region, rotator cuff tear or reconstruction, shoulder dislocation, shoulder instability, frozen shoulder, fracture, and chronic neck pain. This study received ethical approval from the Institutional Review Board (IRB) as minimal risk research (IRB # 2023-0322-01). The study protocol conforms to the ethical guidelines of the 1975 Declaration of Helsinki (Helsinki Declaration as revised in 2013).

Researchers screened potential participants for inclusion criteria. Eligible individuals were given a detailed explanation of the study's purpose, interventions, and their role, followed by informed consent. Participants then completed a demographic information form. To protect confidentiality, participants were assigned numerical identifiers, and all identifying information was stored separately from research data in a secure location.

Outcome measures This study utilized a combination of technologies to measure shoulder muscle activation and ROM. The NORAXON 3D Motion Capture system, equipped with Ultium EMG sensors and Ultium Motion sensors, provided precise tracking of muscle activity and movement patterns (ICC ranging from 0.87-0.98). The Ultium surface EMG Sensors were utilized to detect the Maximum Voluntary Contraction (MVC) as well as muscle activation in the form of % MVC during three different interventions. Ultium Motion ROM sensors were utilized to analyze the PNF D2 shoulder flexion exercise in three different planes of motion via flexion, abduction, and external rotation. Data collection was conducted using MyoMUSCLE and MyoMOTION software.

Participants' subjective feedback was collected using the Borg Rating of Perceived Exertion (RPE) scale and a customized questionnaire including enjoyment, confidence, frustration, boredom, and level of difficulty.

Interventions The Xbox Kinect and BeCure game software were utilized for VR exercises. The U-Ball game challenged participants to hit balls coming from random targets on a screen using the PNF D2 shoulder flexion on their dominant arm. The game setting ensured 14 balls appeared within the intervention period. Visual feedback was provided through an on-screen avatar mirroring the participant's movements. While the game displayed score elements, these were excluded from the study analysis to focus on proper exercise form.

This study implemented three distinct shoulder muscle activation interventions. Intervention I (PNF alone): Foundational PNF D2 shoulder flexion exercise, incorporating shoulder flexion, abduction, and external rotation. This exercise was performed at a metronome-guided pace of 14 beats per minute to establish a consistent baseline and match the U-Ball game's tempo. Intervention II (PNF+VR): Combined the PNF D2 shoulder flexion exercise with a VR motion capture game (the U-Ball game). Intervention III (PNF+VR+CF): PNF D2 shoulder flexion exercise combined with the U-Ball game and the addition of auditory concurrent feedback ("Sword") which referenced the action of unsheathing a sword in a diagonal upward direction. Each intervention lasted 60 seconds, followed by a two-minute rest period which included the survey completion.

Procedures EMG and ROM Sensor Placement Surface EMG electrodes were placed on the identified motor points of the upper trapezius (UT), lower trapezius (LT), infraspinatus (INF), and serratus anterior (SA) muscles. ROM sensors were attached to the upper spine (C7/T1), lower spine (T12/L1), and deltoid tuberosity on the participants' dominant arm. Anatomical landmarks utilized for sensor placement were confirmed by the same two researchers for consistency. A male and female researcher assisted with sensor placement to ensure a respectful and comfortable environment.

Introduction to PNF D2 Flexion Exercise At a learning station, participants were introduced to the PNF D2 shoulder flexion exercise and auditory concurrent feedback via a pre-recorded instructional video. In the video the researcher explained how the auditory "Sword" concurrent feedback was utilized. Another researcher then provided a live demonstration, allowing participants to practice the pattern and confirm their understanding.

MVC Measurements and Calibration Researchers conducted MVC tests for baseline muscle activity. Participants exerted maximum effort against manual resistance applied by the researcher who trained to apply consistent resistance across sessions. ROM sensor calibration took place 1.5 meters from the Xbox Kinect camera, aligning participants with the U-Ball game's software requirements for optimal interaction. Subsequently, muscle activation from UT, LT, SA and INF muscles and shoulder ROM (flexion, abduction, and external rotation) were monitored and recorded for one minute using the MyoMUSCLE and MyoMOTION software (Noraxon Inc.) during the three exercises.

Intervention Administration Participants began with the PNF D2 shoulder exercise at 14 beats per minute paced by a metronome to match the tempo of the U-Ball game for 1 minute. After this initial intervention, participants were given a 2-minute break where they completed a survey (Borg and customized questionnaire). Participants were then randomized for interventions II and III. This randomization involved blindly selecting one of two papers marked II or III, designed to minimize carryover effects.

Conditions
Exercise, Healthy
Being tested
PNF exercise, PNF exercise with virtual reality gaming, PNF with concurrent feedback
Keywords
proprioceptive neuromuscular facilitation, virtual reality, concurrent feedback, shoulder, muscle activation
Medical subject headings
Motor Activity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PNF exerciseOther

    Foundational PNF D2 shoulder flexion exercise incorporating shoulder flexion, abduction, and external rotation. This exercise was performed at a metronome-guided pace of 14 beats per minute to establish a consistent baseline.

  • PNF exercise with virtual reality gamingOther

    Combined the PNF D2 shoulder flexion exercise with a virtual reality motion capture game (the U-Ball game).

  • PNF with concurrent feedbackOther

    PNF exercise with the addition of auditory concurrent feedback ("Sword") which referenced the action of unsheathing a sword in a diagonal upward direction.

Study groups in NCT06667115
Study groupRoleWhat they receive
PNF and PNF with virtual reality and PNF with concurrent feedbackActive comparatorParticipants began with the PNF D2 shoulder exercise for 1 minute. Then participants did PNF D2 exercise with virtual reality gaming as second intervention for 1 minute and then they did PNF D2 exercise with concurrent feedback as third intervention for 1 minute. Between each intervention, participants were given a 2-minute break. Baseline was always PNF exercise, however second and third interventions for the arm 1 and arm 2 were different.
Receives: Other: PNF exercise; Other: PNF exercise with virtual reality gaming; Other: PNF with concurrent feedback
PNF and PNF with concurrent feedback and PNF with virtual reality gamingActive comparatorParticipants began with the PNF D2 shoulder exercise for 1 minute. Then participants did PNF D2 exercise with concurrent feedback as second intervention for 1 minute and then they did PNF D2 exercise with virtual reality gaming as third intervention for 1 minute. Between each intervention, participants were given a 2-minute break. Baseline was always PNF exercise, however second and third interventions for the arm 1 and arm 2 were different.
Receives: Other: PNF exercise; Other: PNF exercise with virtual reality gaming; Other: PNF with concurrent feedback

What is being measured

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

  1. muscle activation

    Using wireless surface electromyography (EMG) (Noraxon USA, Inc.), the activation of the upper trapezius (UT), lower trapezius (LT), infraspinatus (INF), and serratus anterior muscles (SA) were recorded as milivolt.

    Measured: Through study completion, an average of 6 months

  2. Range of motion

    Ultium Motion (Noraxon) range of motion sensors were utilized to record shoulde rmovements during the PNF D2 shoulder flexion exercise in three different planes of motion via flexion, abduction, and external rotation. "Degree" was used as unit measure to record the range of motion.

    Measured: Through study completion, an average of 6 months

Secondary outcomes (4)
  1. Age

    Participants filled demographics survey including age in years.

    Measured: Through study completion, an average of 6 months

  2. Height

    the participants filled demographics survey including height in inches

    Measured: Through study completion, an average of 6 months

  3. weight

    The participants filled demographics survey including weight in pound

    Measured: Through study completion, an average of 6 months

  4. The Borg Rating of Perceived Exertion scale

    The Borg Rating of Perceived Exertion scale that ranges from 6 to 20 where 6 means "no exertion at all" and 20 means "maximal exertion." was used to determine the level of physical activity during therapeutic exercise.

    Measured: Through study completion, an average of 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted31 Oct 2024
  2. Study start30 Apr 2023
  3. Primary completion30 Jun 2023
  4. Study completion30 Dec 2023

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
Crossover
Masking
Single blind
Who is masked
Participant
Enrolment
30 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06667115
Sponsor's protocol ID
Dominican University New York
Acronym
PNF
Status last verified
Oct 2024
First submitted
28 Oct 2024
Last updated
1 Nov 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Lupinacci G, Gatti G, Melegari C, Fontana S. Interactive design of patient-oriented video-games for rehabilitation: concept and application. Disabil Rehabil Assist Technol. 2018 Apr;13(3):234-244. doi: 10.1080/17483107.2017.1306592. Epub 2017 Apr 11.

    PubMed 28398175
  • Ekblom MM, Eriksson M. Concurrent EMG feedback acutely improves strength and muscle activation. Eur J Appl Physiol. 2012 May;112(5):1899-905. doi: 10.1007/s00421-011-2162-2. Epub 2011 Sep 16.

    PubMed 21922262
  • Morais N, Ferreira J, Gordo J, et al. A diagonal movement pattern of arm elevation and depression in overhead throwing athletes: An exploratory kinematic analysis for Clinical Application. Applied Sciences. 2023 Sept 26;13(19):1-15. doi:10.3390/app131910691

  • Forbush SW, Bandy WD, Garrison MK, Graves LC, Roberts R. TESTING INFRASPINATUS AND DELTOID MUSCLES WITH NEW TECHNIQUE TO DECREASE DELTOID ACTIVITY DURING TESTING USING EMG ANALYSIS. Int J Sports Phys Ther. 2018 Aug;13(5):896-904.

    PubMed 30276022
  • Januario LB, Cid MM, Zanca GG, Mattiello SM, Oliveira AB. Serratus anterior sEMG - sensor placement and test position for normalization purposes during maximal and submaximal exertions. Med Eng Phys. 2022 Mar;101:103765. doi: 10.1016/j.medengphy.2022.103765. Epub 2022 Feb 8.

    PubMed 35232545
  • Huang HY, Lin JJ, Guo YL, Wang WT, Chen YJ. EMG biofeedback effectiveness to alter muscle activity pattern and scapular kinematics in subjects with and without shoulder impingement. J Electromyogr Kinesiol. 2013 Feb;23(1):267-74. doi: 10.1016/j.jelekin.2012.09.007. Epub 2012 Nov 2.

    PubMed 23123099
  • Cheng, L., Li, J., Guo, A. et al. Recent advances in flexible noninvasive electrodes for surface electromyography acquisition. npj Flex Electron 7, 39 (2023). https://doi.org/10.1038/s41528-023-00273-0

  • Szczepan S, Zaton K, Fernandez FC, et al. The effects of concurrent visual versus verbal feedback on swimming strength task execution. Balt J Health Phys Act. 2018;10(4):61-71. doi:10.29359/BJHPA.10.4.05.

  • Chen MJ, Fan X, Moe ST. Criterion-related validity of the Borg ratings of perceived exertion scale in healthy individuals: a meta-analysis. J Sports Sci. 2002 Nov;20(11):873-99. doi: 10.1080/026404102320761787.

    PubMed 12430990
  • Chen C, Weyland S, Fritsch J, Woll A, Niessner C, Burchartz A, Schmidt SCE, Jekauc D. A Short Version of the Physical Activity Enjoyment Scale: Development and Psychometric Properties. Int J Environ Res Public Health. 2021 Oct 20;18(21):11035. doi: 10.3390/ijerph182111035.

    PubMed 34769552
  • Grime A, Daines S, Pringle L, et al. The within-day reliability of scapular and shoulder EMG measurements in asymptomatic individuals during shoulder abduction. NZJP. 2023;46(2):67-72. doi:10.15619/NZJP/46.2.02.

  • Alizadehkhaiyat O, Hawkes DH, Kemp GJ, Frostick SP. ELECTROMYOGRAPHIC ANALYSIS OF SHOULDER GIRDLE MUSCLES DURING COMMON INTERNAL ROTATION EXERCISES. Int J Sports Phys Ther. 2015 Oct;10(5):645-54.

    PubMed 26491615
  • Campanini I, Disselhorst-Klug C, Rymer WZ, Merletti R. Surface EMG in Clinical Assessment and Neurorehabilitation: Barriers Limiting Its Use. Front Neurol. 2020 Sep 2;11:934. doi: 10.3389/fneur.2020.00934. eCollection 2020.

    PubMed 32982942
  • San Juan JG, Gunderson SR, Kane-Ronning K, Suprak DN. Scapular kinematic is altered after electromyography biofeedback training. J Biomech. 2016 Jun 14;49(9):1881-1886. doi: 10.1016/j.jbiomech.2016.04.036. Epub 2016 May 3.

    PubMed 27161990
  • Vitali RV, Barone VJ, Ferris J, Stirling LA, Sienko KH. Effects of Concurrent and Terminal Visual Feedback on Ankle Co-Contraction in Older Adults during Standing Balance. Sensors (Basel). 2021 Nov 2;21(21):7305. doi: 10.3390/s21217305.

    PubMed 34770611

Questions about this trial

What is this clinical trial studying?

A study testing PNF exercise, PNF exercise with virtual reality gaming and PNF with concurrent feedback in people with Exercise and Healthy, run by Dominican University New York 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 8 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 1 Nov 2024. 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?

muscle activation (time frame: Through study completion, an average of 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06667115, which also lists 21 linked publications.

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 1 Nov 2024.

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