Assessment of Arm and Hand Sensorimotor Functions in Multiple Sclerosis SubjectsNCT04868370
Validation of a Novel Instrument Task for Assessing Upper Limb
An observational study of Assessment of Arm and Hand Sensorimotor Functions in Multiple Sclerosis Subjects, run by Swiss Federal Institute of Technology at 1 site in Switzerland.
Trial summary
The aim of this study i to investigate a new approach (Physical Peg Insertion Test, PPIT) to measure sensorimotor function in the arm and hand. To achieve this, this novel approach will be compared with an existing approach (Virtual Peg Insertion Test, VPIT). Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Assessment of Arm and Hand Sensorimotor Functions in Multiple Sclerosis Subjects
- What is being tested?
- Assessment of the upper limb (VPIT + PPIT)
- How many people
- 80 participants
- Where
- 1 siteSwitzerland
- Study dates
- 5 May 2021to 31 Jan 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 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Impaired subjects, that suffer from Multiple Sclerosis must be 18 years old and have mild to moderate upper limb disability. Further, they have no strong cognitive deficits or concomitant disease that might affect upper limb performance and they must be able to follow procedures and to give informed consent. Healthy subjects must be 18 years old and must not have any concomitant disease that might affect upper limb performance. Further, they have no strong cognitive deficits and must be able to follow procedures and to give informed consent.
Who may be able to join
- 18 years old
- mild to moderate upper lim disability
- no strong cognitive deficits
- no concomitant disease that might affect upper limb performance
- able to follow procedures and to give informed consent
- Cohort Group: Healthy Subjects
Show all 10Show fewer
- 18 years old
- no cognitive deficits
- no concomitant disease that might affect upper limb performance and
- able to follow procedures and to give informed consent
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Validation of a Novel Instrument Task for Assessing Upper Limb Sensorimotor Impairments in Persons With Chronic Neurological Disorders
The aim of this study i to investigate a new approach (Physical Peg Insertion Test, PPIT) to measure sensorimotor function in the arm and hand. To achieve this, this novel approach will be compared with an existing approach (Virtual Peg Insertion Test, VPIT).
Read the detailed description
In movement disorders, such as multiple sclerosis, impairments in sensorimotor control of goal-directed upper limb movements are commonly present, leading to a decreased ability to perform daily life activities and increased dependence on caregivers . Due to the disabling nature of upper limb impairments, they are often a focus during the neurorehabilitation process of persons with movement disorders. This process relies on a precise description of the presence and severity of sensorimotor impairments through so-called assessments. Specifically, these assessments are essential to individualize therapeutic interventions, to provide documentation for insurances justifying further therapy, and to shed light on the often unknown mechanisms underlying the impairments and their temporal evolution.
Technology-aided assessments can provide detailed movement (kinematic) and grip force (kinetic) data that allows an objective and traceable description of upper limb behaviour. This offers the potential to sensitively characterize sensorimotor impairments and could help significantly reducing sample sizes required in resource-demanding clinical trials. Such technology-aided assessments typically consist of a robotic interface (e.g., exoskeleton or end-effector) that functions as a joystick and a virtual reality environment with a goal-directed manipulation task that is rendered on a 2D computer screen located next to the robotic interface. While these approaches are widely used for research purposes and showed promising results in detecting sensorimotor impairments, certain subjects were observed to have atypical movement patterns and high variability when repeatedly performing the assessment task (high intra-subject variability). These artifacts can results from unintuitive perception of depth on the 2D screen and missing visuomotor collocation, which can induce a bias in the outcome measures of the assessment and reduce the ability of the assessment to capture longitudinal changes (reliability and sensitivity). To overcome these challenges, assessment tasks relying on virtual collocated visuomotor feedback or immersive head mounted displays have been proposed. However, the virtual collocated visuomotor feedback still has its limitations, especially when subjects are supposed to interact with the virtual objects, such as in 3D object manipulation tasks that are typically used in clinical settings. In addition, head mounted display are expected to have limited clinical feasibility in persons that are naïve to technologies or have cognitive impairments.
The aim of this collaborative project between ETH Zurich (Prof. Dr. Gassert, Dr. Lambercy, Dr. Kanzler) and the Kliniken Valens (Dr. med. Dr. sc. nat. Roman Gonzenbach, Ramona Sylvester) is to validate the concept of assessing upper limb sensorimotor impairments with a robotic interface embedded in a novel physical 3D object manipulation task, the Physical Peg Insertion Test (PPIT), and compare it to an existing virtual assessment approach. In more details, the aim is to perform a longitudinal study with the PPIT and its previously validated virtual pendent, the Virtual Peg Insertion Test (VPIT), in persons with movement disorders. This will allow to compare the feasibility, validity, reliability, and sensitivity of both physical and virtual instrumented assessments. Both approaches rely on a CE-certified haptic end-effector device (Geomagic Touch, 3D Systems) and an instrumented handle. For the PPIT, an electromagnet that can be controlled through the applied grip forces is attached to the end-effector and is required to pick up physical magnetic pegs in a physical pegboard task. For the VPIT, a personal computer renders a virtual reality environment with virtual pegs that need to be transported into virtual holes. These approaches have been developed at the Rehabilitation Engineering Laboratory of ETH Zurich and have been shown to be feasible, safe, and time-efficient (5 repetitions of the task, approximately 15 min duration per body side) in able-bodied controls, and persons with stroke, multiple sclerosis, or cerebellar ataxia that have mild to moderate disability levels. While the PPIT has only been developed rather recently, the VPIT has already been extensively used in clinical studies world-wide. Most importantly, the VPIT has already been successfully established as a clinical routine assessment for all persons with multiple sclerosis that are admitted to the Kliniken Valens and is therefore well known to the clinic, which provides the basis for the smooth implementation of the planned project. Through these and other previous tests, sensor data from 120 able-bodied subjects, that serve as a normative database, and over 200 persons with movement disorders could already be recorded. The collected raw kinematic and kinetic data is typically transformed through a signal processing framework into 10 sensor-based metrics that provide information on different aspects of task performance, including for example movement smoothness, accuracy, and speed. Given that the PPIT provides the same sensor data as the VPIT, the signal processing framework of the VPIT can also be applied to the data collected with the PPIT, allowing to extract the 10 sensor-based metrics in both scenarios and serves as a basis for their comparison.
- Being tested
- Assessment of the upper limb (VPIT + PPIT)
- Keywords
- Rehabilitation, Multiple Sclerosis, Sensorimotor Impairment, Assessments, Neurological Disease
- Medical subject headings
- Multiple Sclerosis, Nervous System Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Assessment of the upper limb (VPIT + PPIT)Other
Assessment of the upper limb sensorimotor function (VPIT and PPIT)
| Study group | Role | What they receive |
|---|---|---|
| Multiple Sclerosis (MS) | Not described Receives: Other: Assessment of the upper limb (VPIT + PPIT) | |
| Healthy Subject | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Validation of the Physical Peg Insertion Test (PPIT)
Validate the concept of assessing upper limb sensorimotor impairments with a physical, instrumented 3D object manipulation task (PPIT) by comparing the intra-subject variability, validity, reliability, and sensitivity of the approach to the one of an established, virtual instrumented 3D object manipulation task (VPIT).
Measured: 2 years
Feasibility of the Physical Peg Insertion Test (PPIT)
To judge the feasibility, subjects will be asked to complete a standardized questionnaire based on the System Usability Scale. Subsequently, the 10 sensor-based metrics will be calculated for each assessment based on the same data processing pipeline.
Measured: 2 years
Reliability of the Physical Peg Insertion Test (PPIT)
For describing reliability, the following analysis will be performed across multiple repetitions of the tasks at the same measurement timepoint: the systematic change (learning effects), the standard deviation (intra-subject variability), the intra-class correlation coefficients (ICC, ability to discriminate subjects), and the minimal detectable change (MDC, signal to noise ratio) will be calculated.
Measured: 2 years
Sensitivity of the Physical Peg Insertion Test (PPIT)
The sensitivity of the assessment will be determined based on the number of subjects that the assessment indicates as having meaningful changes in sensorimotor function across the intervention. For this purpose, the magnitude of longitudinal changes will be compared to the noise level of the assessment, as defined by the MDC.
Measured: 2 years
Validity of the Physical Peg Insertion Test (PPIT)
For describing discriminant validity, a receiver operating curve (ROC) analysis between able-bodied controls and persons with movement disorders will be performed to judge the ability of the metrics to detect sensorimotor impairments. For describing concurrent validity, the outcome measures from the PPIT and VPIT will be correlated (Person correlation coefficients) to conventional clinical scales of sensorimotor impairments (e.g., the Nine Hole Peg Test and Box and Block Test).
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2021
- Study start5 May 2021
- Primary completion31 Jan 2023
- Study completion31 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Assessment of Arm and Hand Sensorimotor Functions in Multiple Sclerosis SubjectsStudies 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
- Prospective
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Swiss Federal Institute of Technology
- Sponsor type
- University, hospital or other
- Collaborators
- Kliniken Valens, Rehazentrum Valens, Taminaplatz 1, 7317 Valens
- Responsible party
- Sponsor
- Investigators
- Roman R. Gonzenbach, MD, Principal investigator, Rehazentrum Valens, Taminaplatz 1, 7317 Valens
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04868370
- Sponsor's protocol ID
- BASEC 2021-00633
- Status last verified
- Nov 2023
- First submitted
- 26 Apr 2021
- Last updated
- 29 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of a Novel Instrument Task for Assessing Upper Limb Sensorimotor Impairments in Persons With Chronic Neurological Disorders
- ClinicalTrials.gov ID
- NCT04868370
- Acronym / sponsor ID
- BASEC 2021-00633
- Keywords
- Rehabilitation, Multiple Sclerosis, Sensorimotor Impairment, Assessments, Neurological Disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Swiss Federal Institute of TechnologyUniversity, hospital or other
- Collaborators
- Kliniken Valens, Rehazentrum Valens, Taminaplatz 1, 7317 Valens
- Study start
- 5 May 2021 (actual)
- Primary completion
- 31 Jan 2023 (actual)
- Study completion
- 31 Jan 2023 (actual)
- First posted
- 30 Apr 2021 (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 aim of this study i to investigate a new approach (Physical Peg Insertion Test, PPIT) to measure sensorimotor function in the arm and hand. To achieve this, this novel approach will be compared with an existing approach (Virtual Peg Insertion Test, VPIT).
Detailed description
In movement disorders, such as multiple sclerosis, impairments in sensorimotor control of goal-directed upper limb movements are commonly present, leading to a decreased ability to perform daily life activities and increased dependence on caregivers . Due to the disabling nature of upper limb impairments, they are often a focus during the neurorehabilitation process of persons with movement disorders. This process relies on a precise description of the presence and severity of sensorimotor impairments through so-called assessments. Specifically, these assessments are essential to individualize therapeutic interventions, to provide documentation for insurances justifying further therapy, and to shed light on the often unknown mechanisms underlying the impairments and their temporal evolution.
Technology-aided assessments can provide detailed movement (kinematic) and grip force (kinetic) data that allows an objective and traceable description of upper limb behaviour. This offers the potential to sensitively characterize sensorimotor impairments and could help significantly reducing sample sizes required in resource-demanding clinical trials. Such technology-aided assessments typically consist of a robotic interface (e.g., exoskeleton or end-effector) that functions as a joystick and a virtual reality environment with a goal-directed manipulation task that is rendered on a 2D computer screen located next to the robotic interface. While these approaches are widely used for research purposes and showed promising results in detecting sensorimotor impairments, certain subjects were observed to have atypical movement patterns and high variability when repeatedly performing the assessment task (high intra-subject variability). These artifacts can results from unintuitive perception of depth on the 2D screen and missing visuomotor collocation, which can induce a bias in the outcome measures of the assessment and reduce the ability of the assessment to capture longitudinal changes (reliability and sensitivity). To overcome these challenges, assessment tasks relying on virtual collocated visuomotor feedback or immersive head mounted displays have been proposed. However, the virtual collocated visuomotor feedback still has its limitations, especially when subjects are supposed to interact with the virtual objects, such as in 3D object manipulation tasks that are typically used in clinical settings. In addition, head mounted display are expected to have limited clinical feasibility in persons that are naïve to technologies or have cognitive impairments.
The aim of this collaborative project between ETH Zurich (Prof. Dr. Gassert, Dr. Lambercy, Dr. Kanzler) and the Kliniken Valens (Dr. med. Dr. sc. nat. Roman Gonzenbach, Ramona Sylvester) is to validate the concept of assessing upper limb sensorimotor impairments with a robotic interface embedded in a novel physical 3D object manipulation task, the Physical Peg Insertion Test (PPIT), and compare it to an existing virtual assessment approach. In more details, the aim is to perform a longitudinal study with the PPIT and its previously validated virtual pendent, the Virtual Peg Insertion Test (VPIT), in persons with movement disorders. This will allow to compare the feasibility, validity, reliability, and sensitivity of both physical and virtual instrumented assessments. Both approaches rely on a CE-certified haptic end-effector device (Geomagic Touch, 3D Systems) and an instrumented handle. For the PPIT, an electromagnet that can be controlled through the applied grip forces is attached to the end-effector and is required to pick up physical magnetic pegs in a physical pegboard task. For the VPIT, a personal computer renders a virtual reality environment with virtual pegs that need to be transported into virtual holes. These approaches have been developed at the Rehabilitation Engineering Laboratory of ETH Zurich and have been shown to be feasible, safe, and time-efficient (5 repetitions of the task, approximately 15 min duration per body side) in able-bodied controls, and persons with stroke, multiple sclerosis, or cerebellar ataxia that have mild to moderate disability levels. While the PPIT has only been developed rather recently, the VPIT has already been extensively used in clinical studies world-wide. Most importantly, the VPIT has already been successfully established as a clinical routine assessment for all persons with multiple sclerosis that are admitted to the Kliniken Valens and is therefore well known to the clinic, which provides the basis for the smooth implementation of the planned project. Through these and other previous tests, sensor data from 120 able-bodied subjects, that serve as a normative database, and over 200 persons with movement disorders could already be recorded. The collected raw kinematic and kinetic data is typically transformed through a signal processing framework into 10 sensor-based metrics that provide information on different aspects of task performance, including for example movement smoothness, accuracy, and speed. Given that the PPIT provides the same sensor data as the VPIT, the signal processing framework of the VPIT can also be applied to the data collected with the PPIT, allowing to extract the 10 sensor-based metrics in both scenarios and serves as a basis for their comparison.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Multiple Sclerosis (MS) | – | Other: Assessment of the upper limb (VPIT + PPIT) |
| Healthy Subject | – | – |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Impaired subjects, that suffer from Multiple Sclerosis must be 18 years old and have mild to moderate upper limb disability. Further, they have no strong cognitive deficits or concomitant disease that might affect upper limb performance and they must be able to follow procedures and to give informed consent. Healthy subjects must be 18 years old and must not have any concomitant disease that might affect upper limb performance. Further, they have no strong cognitive deficits and must be able to follow procedures and to give informed consent.
Key inclusion criteria (10 listed)
- 18 years old
- mild to moderate upper lim disability
- no strong cognitive deficits
- no concomitant disease that might affect upper limb performance
- able to follow procedures and to give informed consent
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Assessment of the upper limb (VPIT + PPIT)Assessment of the upper limb sensorimotor function (VPIT and PPIT) | Other | Multiple Sclerosis (MS) |
Primary outcome
Validation of the Physical Peg Insertion Test (PPIT)
Time frame: 2 years
Validate the concept of assessing upper limb sensorimotor impairments with a physical, instrumented 3D object manipulation task (PPIT) by comparing the intra-subject variability, validity, reliability, and sensitivity of the approach to the one of an established, virtual instrumented 3D object manipulation task (VPIT).
Feasibility of the Physical Peg Insertion Test (PPIT)
Time frame: 2 years
To judge the feasibility, subjects will be asked to complete a standardized questionnaire based on the System Usability Scale. Subsequently, the 10 sensor-based metrics will be calculated for each assessment based on the same data processing pipeline.
Reliability of the Physical Peg Insertion Test (PPIT)
Time frame: 2 years
For describing reliability, the following analysis will be performed across multiple repetitions of the tasks at the same measurement timepoint: the systematic change (learning effects), the standard deviation (intra-subject variability), the intra-class correlation coefficients (ICC, ability to discriminate subjects), and the minimal detectable change (MDC, signal to noise ratio) will be calculated.
Sensitivity of the Physical Peg Insertion Test (PPIT)
Time frame: 2 years
The sensitivity of the assessment will be determined based on the number of subjects that the assessment indicates as having meaningful changes in sensorimotor function across the intervention. For this purpose, the magnitude of longitudinal changes will be compared to the noise level of the assessment, as defined by the MDC.
Validity of the Physical Peg Insertion Test (PPIT)
Time frame: 2 years
For describing discriminant validity, a receiver operating curve (ROC) analysis between able-bodied controls and persons with movement disorders will be performed to judge the ability of the metrics to detect sensorimotor impairments. For describing concurrent validity, the outcome measures from the PPIT and VPIT will be correlated (Person correlation coefficients) to conventional clinical scales of sensorimotor impairments (e.g., the Nine Hole Peg Test and Box and Block Test).
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 29 Nov 2023.
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.
Roman R. Gonzenbach, MD principal investigator
Rehazentrum Valens, Taminaplatz 1, 7317 Valens
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 Assessment of Arm and Hand Sensorimotor Functions in Multiple Sclerosis Subjects, run by Swiss Federal Institute of Technology at 1 site in Switzerland.
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 10 inclusion and 0 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 29 Nov 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 Switzerland. 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?
Validation of the Physical Peg Insertion Test (PPIT) (time frame: 2 years). The study lists 5 primary outcomes in all. 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 29 Nov 2023.