HealthyNCT05819047
Assessment of Upper Limb Motor Performance Using an Interface With Haptic Feedback
An observational study of Healthy, run by Universidad Nacional de Entre Rios at 1 site in Argentina.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Functional test with a haptic device
- Type of treatment
- Medical device
- How many people
- 30 participants
- Where
- 1 siteArgentina
- Study dates
- 9 May 2023to 14 Dec 2023
- Phase
- Observational
- 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 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Healthy volunteers
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 12Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
Argentina1 site
Facultad de Ingeniería, Universidad Nacional de Entre Ríos
Oro Verde, Entre Ríos Province, 3100
About this study
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.
Read the detailed description
Experimental setup Volunteers will be received at the Center of Rehabilitation Engineering and Neuromuscular and Sensory Research (CIRINS). They will be informed, in simple terms, of the purpose of the project and the measurements that will be done during the session. The Informed Consent Form will be read to each volunteer and, if they decide to participate, they will be asked to sign a copy that will be filed in the Laboratory together with their contact information, which will be stored confidentially.
At the beginning of the session, the volunteer will be asked to sit comfortably. The EEG electrodes will then be attached using a 16-electrode cap in the standard 10-20 location, together with the exoskeleton in the position determined by the investigator. The position of the camera that will be used to follow the movements of the upper limb will also be adjusted to ensure that the movements will be within the camera's field of view.
Subsequently, the subject will be placed in its initial position: seated, with approximately 45° of shoulder abduction, 10° of shoulder flexion and 90° of elbow flexion.
Once the subject is in the proper position, they will be asked, using the implemented test interface, to perform the virtual nine-hole peg test (NHPT) in Cue Based and Self Paced variants. The volunteer will be asked to complete these tests with both hands, in order to assess whether there are differences in performance associated with the side with which the test is performed, and whether using the system is sensitive enough to detect these changes. The researcher conducting the experiment should record which test was performed with the dominant hand and which was not.
To evaluate whether the results obtained are satisfactory, they will be compared with those reported for healthy individuals.
Evaluation tests Cue-based nine-hole peg test: this test works with time or event dependent cues, dividing the test into several repetitions of the same task. Each trial starts at the same predetermined position, and consists of placing as quickly as possible a random peg in a random hole. This randomness is given in the order of the first nine attempts without repeating the peg. Then, in case of additional attempts, the order of the first nine attempts is repeated. In case of failure to complete an attempt within a certain time or placing the peg in the wrong hole, it is given as failed. The signals presented to the user are visual. The pegs change color from white (inactive) to red, which marks the peg that should move (but without giving the signal to move yet), when the peg changes to green, the movement should begin. Likewise, the hole into which the peg should be inserted is marked with the addition of a translucent light blue object. Inactive holes have no color or object inside. At the end of a repetition, the position of the pegs is reset. The starting point of each repetition of the test is marked with a translucent sphere, which is the position that the robot cursor must take before the next attempt. This object sees its position reflected along with the other elements of the virtual environment when changing hands.
Self-paced nine-hole peg test : this test gives the user the freedom to place the desired peg in the desired hole at the desired speed. This test is the most similar to the original NHPT, and ends when all nine pegs are placed in the nine holes, giving as a result the total duration of the test.
- Conditions
- Healthy
- Being tested
- Functional test with a haptic device
- Keywords
- Haptic technology, Musculoskeletal pain, Virtual environment
- Medical subject headings
- Musculoskeletal Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Functional test with a haptic deviceDevice
Volunteers will complete two tests based on the Nine Hole Peg Test with a haptic device.
| Study group | Role | What they receive |
|---|---|---|
| Healthy | Healthy volunteers Receives: Device: Functional test with a haptic device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Movement smoothness
Smoothness of the participant movement calculated through the fourth derivative of the trajectory (jerk).
Measured: Average of 36 trials during a single experimental session with a duration of 30 minutes
Secondary outcomes (7)
Log jerk transport
Smoothness of the peg transport trajectory, from the initial position to the hole.
Measured: Average of 36 trials during a single experimental session with a duration of 30 minutes
Log jerk return
Smoothness of the return trajectory, from the position of the hole where the last peg was inserted to the initial position of the next peg.
Measured: Average of 36 trials during a single experimental session with a duration of 30 minutes
SPARC return
Smoothness of the return trajectory, from the position of the hole where the last peg was inserted to the initial position of the next peg.
Measured: Average of 36 trials during a single experimental session with a duration of 30 minutes
Path length ratio transport
Efficiency of the peg transport trajectory, from the initial position to the hole.
Measured: Average of 36 trials during a single experimental session with a duration of 30 minutes
Path length ratio return
Efficiency of the return trajectory, from the position of the hole where the last peg was inserted to the initial position of the next peg.
Measured: Average of 36 trials during a single experimental session with a duration of 30 minutes
Velocity max. return
Maximum velocity during the return trajectory, from the position of the hole where the last peg was inserted to the initial position of the next peg.
Measured: Average of 36 trials during a single experimental session with a duration of 30 minutes
Jerk peg approach
Precision of the ballistic movement during the approach to the peg (near the end of the return and just before the beginning of transport).
Measured: Average of 36 trials during a single experimental session with a duration of 30 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2023
- Study start9 May 2023
- Primary completion14 Dec 2023
- Study completion14 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (17)Papers the sponsor has linked to this study.
- Other trials for HealthyStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad Nacional de Entre Rios
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rosa María Weisz, Universidad Nacional de Entre Rios
- Investigators
- Rosa M Weisz, MSc. in Biomed Eng, Principal investigator, Universidad Nacional de Entre Rios
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05819047
- Sponsor's protocol ID
- IS003960
- Status last verified
- Dec 2023
- First submitted
- 5 Apr 2023
- Last updated
- 19 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All collected IPD except video recordings.
Publications
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.
PubMed 29505418Hodges 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.
PubMed 21087823Karos 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.
PubMed 28444803Tsay 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.
PubMed 25783221Rigsby 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.
PubMed 31021805Kanzler 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.
PubMed 32977810Kanzler 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.
PubMed 32529042Schwarz 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.
PubMed 30776997Wright 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.
PubMed 21462065Feys 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.
PubMed 28206826Spuler 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.
PubMed 25859204J. 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
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.
PubMed 34489855Mista 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.
PubMed 31251430Gatti 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.
PubMed 32781497
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Upper Limb Motor Performance Using an Interface With Haptic Feedback
- ClinicalTrials.gov ID
- NCT05819047
- Acronym / sponsor ID
- IS003960
- Conditions
- Healthy
- Keywords
- Haptic technology, Musculoskeletal pain, Virtual environment
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Universidad Nacional de Entre RiosUniversity, hospital or other
- Study start
- 9 May 2023 (actual)
- Primary completion
- 14 Dec 2023 (actual)
- Study completion
- 14 Dec 2023 (actual)
- First posted
- 19 Apr 2023 (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.
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.
Detailed description
Experimental setup Volunteers will be received at the Center of Rehabilitation Engineering and Neuromuscular and Sensory Research (CIRINS). They will be informed, in simple terms, of the purpose of the project and the measurements that will be done during the session. The Informed Consent Form will be read to each volunteer and, if they decide to participate, they will be asked to sign a copy that will be filed in the Laboratory together with their contact information, which will be stored confidentially.
At the beginning of the session, the volunteer will be asked to sit comfortably. The EEG electrodes will then be attached using a 16-electrode cap in the standard 10-20 location, together with the exoskeleton in the position determined by the investigator. The position of the camera that will be used to follow the movements of the upper limb will also be adjusted to ensure that the movements will be within the camera's field of view.
Subsequently, the subject will be placed in its initial position: seated, with approximately 45° of shoulder abduction, 10° of shoulder flexion and 90° of elbow flexion.
Once the subject is in the proper position, they will be asked, using the implemented test interface, to perform the virtual nine-hole peg test (NHPT) in Cue Based and Self Paced variants. The volunteer will be asked to complete these tests with both hands, in order to assess whether there are differences in performance associated with the side with which the test is performed, and whether using the system is sensitive enough to detect these changes. The researcher conducting the experiment should record which test was performed with the dominant hand and which was not.
To evaluate whether the results obtained are satisfactory, they will be compared with those reported for healthy individuals.
Evaluation tests Cue-based nine-hole peg test: this test works with time or event dependent cues, dividing the test into several repetitions of the same task. Each trial starts at the same predetermined position, and consists of placing as quickly as possible a random peg in a random hole. This randomness is given in the order of the first nine attempts without repeating the peg. Then, in case of additional attempts, the order of the first nine attempts is repeated. In case of failure to complete an attempt within a certain time or placing the peg in the wrong hole, it is given as failed. The signals presented to the user are visual. The pegs change color from white (inactive) to red, which marks the peg that should move (but without giving the signal to move yet), when the peg changes to green, the movement should begin. Likewise, the hole into which the peg should be inserted is marked with the addition of a translucent light blue object. Inactive holes have no color or object inside. At the end of a repetition, the position of the pegs is reset. The starting point of each repetition of the test is marked with a translucent sphere, which is the position that the robot cursor must take before the next attempt. This object sees its position reflected along with the other elements of the virtual environment when changing hands.
Self-paced nine-hole peg test : this test gives the user the freedom to place the desired peg in the desired hole at the desired speed. This test is the most similar to the original NHPT, and ends when all nine pegs are placed in the nine holes, giving as a result the total duration of the test.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Healthy | – | Device: Functional test with a haptic deviceHealthy volunteers |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Healthy volunteers
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (12 listed)
- 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.
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 |
|---|---|---|
| Functional test with a haptic deviceVolunteers will complete two tests based on the Nine Hole Peg Test with a haptic device. | Device | Healthy |
Primary outcome
Movement smoothness
Time frame: Average of 36 trials during a single experimental session with a duration of 30 minutes
Smoothness of the participant movement calculated through the fourth derivative of the trajectory (jerk).
7 secondary outcomes
Log jerk transport
Time frame: Average of 36 trials during a single experimental session with a duration of 30 minutes
Log jerk return
Time frame: Average of 36 trials during a single experimental session with a duration of 30 minutes
SPARC return
Time frame: Average of 36 trials during a single experimental session with a duration of 30 minutes
Path length ratio transport
Time frame: Average of 36 trials during a single experimental session with a duration of 30 minutes
Path length ratio return
Time frame: Average of 36 trials during a single experimental session with a duration of 30 minutes
Velocity max. return
Time frame: Average of 36 trials during a single experimental session with a duration of 30 minutes
Jerk peg approach
Time frame: Average of 36 trials during a single experimental session with a duration of 30 minutes
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 Dec 2023.
- Background: PubMed 29505418Mista 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.
- Background: PubMed 21087823Hodges 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.
- Background: PubMed 28444803Karos 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.
- Background: PubMed 25783221Tsay 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.
- Background: PubMed 31021805Rigsby 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.
- Background: PubMed 32977810Kanzler 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.
- Background: PubMed 32529042Kanzler 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.
- Background: PubMed 30776997Schwarz 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.
- Background: PubMed 21462065Wright 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.
- Background: PubMed 28206826Feys 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.
- Background: PubMed 25859204Spuler 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.
- BackgroundJ. 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
- Individual participant dataSharing planned: Yes. All collected IPD except video recordings.
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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.
Rosa M Weisz, MSc. in Biomed Eng principal investigator
Universidad Nacional de Entre Rios
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Healthy, run by Universidad Nacional de Entre Rios at 1 site in Argentina.
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 3 inclusion and 12 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 Dec 2023. 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 Argentina. 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?
Movement smoothness (time frame: Average of 36 trials during a single experimental session with a duration of 30 minutes). 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 NCT05819047, which also lists 17 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 19 Dec 2023.