NCT06667115

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 30, 2023

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2023

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2023

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

October 28, 2024

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 31, 2024

Completed
Last Updated

November 1, 2024

Status Verified

October 1, 2024

Enrollment Period

2 months

First QC Date

October 28, 2024

Last Update Submit

October 30, 2024

Conditions

Keywords

proprioceptive neuromuscular facilitationvirtual realityconcurrent feedbackshouldermuscle activation

Outcome Measures

Primary Outcomes (2)

  • 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.

    Through study completion, an average of 6 months

  • 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.

    Through study completion, an average of 6 months

Secondary Outcomes (4)

  • Age

    Through study completion, an average of 6 months

  • Height

    Through study completion, an average of 6 months

  • weight

    Through study completion, an average of 6 months

  • The Borg Rating of Perceived Exertion scale

    Through study completion, an average of 6 months

Study Arms (2)

PNF and PNF with virtual reality and PNF with concurrent feedback

ACTIVE COMPARATOR

Participants 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.

Other: PNF exerciseOther: PNF exercise with virtual reality gamingOther: PNF with concurrent feedback

PNF and PNF with concurrent feedback and PNF with virtual reality gaming

ACTIVE COMPARATOR

Participants 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.

Other: PNF exerciseOther: PNF exercise with virtual reality gamingOther: PNF with concurrent feedback

Interventions

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 and PNF with concurrent feedback and PNF with virtual reality gamingPNF and PNF with virtual reality and PNF with concurrent feedback

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

PNF and PNF with concurrent feedback and PNF with virtual reality gamingPNF and PNF with virtual reality and PNF with concurrent feedback

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

PNF and PNF with concurrent feedback and PNF with virtual reality gamingPNF and PNF with virtual reality and PNF with concurrent feedback

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dominican University New York, Doctor of Physical Therapy Program

Orangeburg, New York, 10962, United States

Location

Related Publications (21)

  • 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.

  • 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.

  • 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

    RESULT
  • 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.

  • 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.

  • 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.

  • 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

    RESULT
  • 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.

    RESULT
  • 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.

  • 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.

  • 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.

    RESULT
  • 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.

  • 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.

  • 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.

  • 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.

  • Youdas JW, Arend DB, Exstrom JM, Helmus TJ, Rozeboom JD, Hollman JH. Comparison of muscle activation levels during arm abduction in the plane of the scapula vs. proprioceptive neuromuscular facilitation upper extremity patterns. J Strength Cond Res. 2012 Apr;26(4):1058-65. doi: 10.1519/JSC.0b013e31822e597f.

  • Knippenberg E, Verbrugghe J, Lamers I, Palmaers S, Timmermans A, Spooren A. Markerless motion capture systems as training device in neurological rehabilitation: a systematic review of their use, application, target population and efficacy. J Neuroeng Rehabil. 2017 Jun 24;14(1):61. doi: 10.1186/s12984-017-0270-x.

  • Lee HL, Khairunizam W, Cahyadi BN, et al. Progress monitoring in upper limb stroke rehabilitation by using muscle activation and hand speed. J Phys: Conf Ser. 2020;1529(4):042019. doi:10.1088/1742-6596/1529/4/042019

    RESULT
  • Fuertes Munoz G, Mollineda RA, Gallardo Casero J, Pla F. A RGBD-Based Interactive System for Gaming-Driven Rehabilitation of Upper Limbs. Sensors (Basel). 2019 Aug 9;19(16):3478. doi: 10.3390/s19163478.

  • Zaidi S, Ahamad A, Fatima A, Ahmad I, Malhotra D, Al Muslem WH, Abdulaziz S, Nuhmani S. Immediate and Long-Term Effectiveness of Proprioceptive Neuromuscular Facilitation and Static Stretching on Joint Range of Motion, Flexibility, and Electromyographic Activity of Knee Muscles in Older Adults. J Clin Med. 2023 Mar 30;12(7):2610. doi: 10.3390/jcm12072610.

  • Witt D, Talbott N, Kotowski S. Electromyographic activity of scapular muscles during diagonal patterns using elastic resistance and free weights. Int J Sports Phys Ther. 2011 Dec;6(4):322-32.

MeSH Terms

Conditions

Motor Activity

Interventions

Muscle Stretching Exercises

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Exercise TherapyRehabilitationAftercareContinuity of Patient CarePatient CareTherapeuticsPhysical Therapy ModalitiesExerciseMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Ayse Edeer, PT, PhD

    Dominican University New York

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

October 28, 2024

First Posted

October 31, 2024

Study Start

April 30, 2023

Primary Completion

June 30, 2023

Study Completion

December 30, 2023

Last Updated

November 1, 2024

Record last verified: 2024-10

Data Sharing

IPD Sharing
Will not share

Locations