Assessment of Upper Limb Motor Performance Using an Interface With Haptic Feedback

NCT05819047 | Completed

• 1 other identifier: IS003960
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of the study is to test an evaluation environment based on a device that has the ability to provide the user with tactile (haptic) sensations. This environment will be used to investigate how the arm movements of a healthy person are performed, and then - at a later stage - to find out whether it is possible to measure changes during musculoskeletal pain. Electrical signals produced by the brain (called electroencephalogram or EEG) will be recorded by means of electrodes on the surface of the scalp (non-invasive). In addition, the angle of the elbow joint during movement will be measured, with the intention of using objective measures to aid future evidence-based clinical decision making. It is expected that the developed environment can be used -in the near future-, to evaluate the progression of pathologies associated with muscle pain, or to quantify the effectiveness of rehabilitation therapies.

Conditions

Healthy

Keywords

Haptic technology; Musculoskeletal pain; Virtual environment

Outcome Measures

Primary Outcomes (1)

• Movement smoothness

  Smoothness of the participant movement calculated through the fourth derivative of the trajectory (jerk).

  Average of 36 trials during a single experimental session with a duration of 30 minutes

Secondary Outcomes (7)

• Log jerk transport

  Average of 36 trials during a single experimental session with a duration of 30 minutes

• Log jerk return

  Average of 36 trials during a single experimental session with a duration of 30 minutes

• SPARC return

  Average of 36 trials during a single experimental session with a duration of 30 minutes

• Path length ratio transport

  Average of 36 trials during a single experimental session with a duration of 30 minutes

• Path length ratio return

  Average of 36 trials during a single experimental session with a duration of 30 minutes

Study Arms (1)

Healthy

Healthy volunteers

Device: Functional test with a haptic device

Interventions

Functional test with a haptic device DEVICE

Volunteers will complete two tests based on the Nine Hole Peg Test with a haptic device.

Healthy

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Healthy volunteers

You may qualify if:

• No history of neurological disease, chronic pain, or musculoskeletal disorders.
• Willingness and ability to fully understand the content and scope of the experiment and to comply with the instructions.
• Signature of the informed consent document.

You may not qualify if:

• Pregnancy.
• History of chronic pain or neuromuscular disorders.
• History of addictive behavior, defined as abuse of alcohol, cannabis, opioids or other drugs.
• History of heat sensitivity disorders.
• Presence of fever, tuberculosis, malignant tumors, infectious processes, acute inflammatory processes.
• Implantation of pacemakers or metallic prostheses.
• Use of analgesics within 24 hours prior to participation in the experiment.
• Lack of cooperation.
• Trauma of the segment to be evaluated in the last 4 weeks.
• Surgical history of the upper quadrant.
• Metabolic diseases.
• Ingestion of pain medication in the last 24 hs.

Sponsors & Collaborators

• Universidad Nacional de Entre Rios: lead

Study Sites (1)

Facultad de Ingeniería, Universidad Nacional de Entre Ríos

Oro Verde, Entre Ríos Province, 3100, Argentina

Location

Related Publications (17)

• Mista CA, Monterde S, Ingles M, Salvat I, Graven-Nielsen T. Reorganized Force Control in Elbow Pain Patients During Isometric Wrist Extension. Clin J Pain. 2018 Aug;34(8):732-738. doi: 10.1097/AJP.0000000000000596.

  PMID: 29505418 BACKGROUND

• Hodges PW, Tucker K. Moving differently in pain: a new theory to explain the adaptation to pain. Pain. 2011 Mar;152(3 Suppl):S90-S98. doi: 10.1016/j.pain.2010.10.020. Epub 2010 Nov 18. No abstract available.

  PMID: 21087823 BACKGROUND

• Karos K, Meulders A, Gatzounis R, Seelen HAM, Geers RPG, Vlaeyen JWS. Fear of pain changes movement: Motor behaviour following the acquisition of pain-related fear. Eur J Pain. 2017 Sep;21(8):1432-1442. doi: 10.1002/ejp.1044. Epub 2017 Apr 25.

  PMID: 28444803 BACKGROUND

• Tsay A, Allen TJ, Proske U, Giummarra MJ. Sensing the body in chronic pain: a review of psychophysical studies implicating altered body representation. Neurosci Biobehav Rev. 2015 May;52:221-32. doi: 10.1016/j.neubiorev.2015.03.004. Epub 2015 Mar 14.

  PMID: 25783221 BACKGROUND

• Rigsby B, Reed KB. Accuracy of Dynamic Force Compensation Varies With Direction and Speed. IEEE Trans Haptics. 2019 Oct-Dec;12(4):658-664. doi: 10.1109/TOH.2019.2912375. Epub 2019 Apr 23.

  PMID: 31021805 BACKGROUND

• Kanzler CM, Schwarz A, Held JPO, Luft AR, Gassert R, Lambercy O. Technology-aided assessment of functionally relevant sensorimotor impairments in arm and hand of post-stroke individuals. J Neuroeng Rehabil. 2020 Sep 25;17(1):128. doi: 10.1186/s12984-020-00748-5.

  PMID: 32977810 BACKGROUND

• Kanzler CM, Rinderknecht MD, Schwarz A, Lamers I, Gagnon C, Held JPO, Feys P, Luft AR, Gassert R, Lambercy O. A data-driven framework for selecting and validating digital health metrics: use-case in neurological sensorimotor impairments. NPJ Digit Med. 2020 May 29;3:80. doi: 10.1038/s41746-020-0286-7. eCollection 2020.

  PMID: 32529042 BACKGROUND

• Schwarz A, Kanzler CM, Lambercy O, Luft AR, Veerbeek JM. Systematic Review on Kinematic Assessments of Upper Limb Movements After Stroke. Stroke. 2019 Mar;50(3):718-727. doi: 10.1161/STROKEAHA.118.023531.

  PMID: 30776997 BACKGROUND

• Wright DJ, Holmes PS, Smith D. Using the movement-related cortical potential to study motor skill learning. J Mot Behav. 2011;43(3):193-201. doi: 10.1080/00222895.2011.557751.

  PMID: 21462065 BACKGROUND

• Feys P, Lamers I, Francis G, Benedict R, Phillips G, LaRocca N, Hudson LD, Rudick R; Multiple Sclerosis Outcome Assessments Consortium. The Nine-Hole Peg Test as a manual dexterity performance measure for multiple sclerosis. Mult Scler. 2017 Apr;23(5):711-720. doi: 10.1177/1352458517690824. Epub 2017 Feb 16.

  PMID: 28206826 BACKGROUND

• Spuler M, Niethammer C. Error-related potentials during continuous feedback: using EEG to detect errors of different type and severity. Front Hum Neurosci. 2015 Mar 26;9:155. doi: 10.3389/fnhum.2015.00155. eCollection 2015.

  PMID: 25859204 BACKGROUND

• J. D. Guzmán, E. F. Fonseca, C. F. Rengifo, D. E. Guzmán, J. Londoño and E. Muñoz, "Implementación de la prueba de funcionalidad motriz de miembro superior nine-hole peg test en un entorno virtual 3D", Iberdiscap, 2017

  BACKGROUND

• Ahmed T, Thopalli K, Rikakis T, Turaga P, Kelliher A, Huang JB, Wolf SL. Automated Movement Assessment in Stroke Rehabilitation. Front Neurol. 2021 Aug 19;12:720650. doi: 10.3389/fneur.2021.720650. eCollection 2021.

  PMID: 34489855 BACKGROUND

• Mista CA, Laugero SJ, Adur JF, Andersen OK, Biurrun Manresa JA. A new experimental model of muscle pain in humans based on short-wave diathermy. Eur J Pain. 2019 Oct;23(9):1733-1742. doi: 10.1002/ejp.1449. Epub 2019 Jul 24.

  PMID: 31251430 BACKGROUND

• Gatti R, Atum Y, Schiaffino L, Jochumsen M, Biurrun Manresa J. Decoding kinetic features of hand motor preparation from single-trial EEG using convolutional neural networks. Eur J Neurosci. 2021 Jan;53(2):556-570. doi: 10.1111/ejn.14936. Epub 2020 Aug 25.

  PMID: 32781497 BACKGROUND

• W. Wei, "Virtual reality enhanced robotic systems for disability rehabilitation," in Virtual and Augmented Reality: Concepts, Methodologies, Tools, and Applications, 2018

  BACKGROUND

• S. Mahamad, S. M. Taib, and M. N. Ibrahim, "Analyzing speed accuracy trade-off in control movement mechanism with error enforcement," in Applied Mechanics and Materials, 2011.

  BACKGROUND

MeSH Terms

Conditions

Musculoskeletal Pain

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Rosa M Weisz, MSc. in Biomed Eng

  Universidad Nacional de Entre Rios

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 5, 2023
• First Posted: April 19, 2023
• Study Start: May 9, 2023
• Primary Completion: December 14, 2023
• Study Completion: December 14, 2023
• Last Updated: December 19, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ANALYTIC CODE
• Time Frame: The study protocol is available since the protocol registration. IPD, SAP and analytic code will be available 6 months after data collection.
• Access Criteria: Open access in a public platform.

Locations

AR (1)