Neurological Diseases or ConditionsNCT03619642
Reliability, Validity and Clinical Utility of a Robotic Assessment for Proprioception
A study testing Robotic assessment of finger proprioception in people with Neurological Diseases or Conditions and Sensory Disorders, run by Hasselt University at 2 sites in Belgium.
Trial summary
The aim of this case-controlled observational cross-sectional study is to investigate the test-retest reliability, validity and clinical utility of a rapid robotic assessment of finger proprioception using a passive gauge position matching tasks in MS and stroke subjects. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Neurological Diseases or Conditions, Sensory Disorders, Multiple Sclerosis
- What is being tested?
- Robotic assessment of finger proprioception
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 2 sitesBelgium
- Study dates
- 15 Dec 2017to 31 May 2018
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age > 18 years
- Diagnosis of MS (McDonald criteria)
- No relapse or relapse-related treatment within the last 3 months prior to the study
- Age > 18 years
- Diagnosis of stroke (ischemic or hemorrhagic),
- Between 2 weeks and 12 months post-stroke
Who cannot join
- Complete paralysis of both upper limbs
- Unable to detect any passive movement in hand and fingers
- Unable to place the hand in the robotic devices without any discomfort or pain
- Marked or severe intention tremor (Fahn's tremor rating scale on finger-to-nose test > 3)
- Marked or severe spasticity for finger and elbow flexors or shoulder adductors (Modified Asworth scale >3)
- Other medical conditions interfering with the hand function (peripheral nerve lesion, orthopedic or rheumatoid impairment, pain, edema)
- Severe cognitive or visual deficits interfering with testing and training (e.g. Aphasia, neglect, …)
Trial locations and contacts
2 sites in 1 country.
Belgium2 sites
Jessa Ziekenhuis
Hasselt, 3590
Revalidatie & MS Centrum Overpelt
Overpelt
About this study
Official title: Reliability, Validity and Clinical Utility of a Robotic Assessment of Finger Proprioception in Neurological Subjects
The aim of this case-controlled observational cross-sectional study is to investigate the test-retest reliability, validity and clinical utility of a rapid robotic assessment of finger proprioception using a passive gauge position matching tasks in MS and stroke subjects.
Session 1 Informed consent Descriptive measures Session 2 Clinical testing Robotic assessment (3x) Session 3 Clinical testing Robotic assessment (3x)
- Being tested
- Robotic assessment of finger proprioception
- Medical subject headings
- Sensation Disorders, Multiple Sclerosis, Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Robotic assessment of finger proprioceptionOther
The assessment will be performed using a robotic device specifically designed for the assessment of finger proprioception at the metacarpophalangeal (MCP) joint .
| Study group | Role | What they receive |
|---|---|---|
| persons with Multiple Sclerosis (MS) | Other | 25 persons with MS Persons are tested on proprioception of the interphalangeal joints of teh fingers by means of a robotic device. Receives: Other: Robotic assessment of finger proprioception |
| stroke patients | Other | 25 stroke patients Persons are tested on proprioception of the interphalangeal joints of teh fingers by means of a robotic device. Receives: Other: Robotic assessment of finger proprioception |
| healthy controls | Other | 50 healthy controls Persons are tested on proprioception of the interphalangeal joints of teh fingers by means of a robotic device. Receives: Other: Robotic assessment of finger proprioception |
What is being measured
The primary outcome is the main question the study is designed to answer.
Error
The extracted parameter is measured by the robotic device. The MCP angular position measured by the robot and the angle reported on the touchscreen by the subject.
Measured: day 2
Error
The extracted parameter is measured by the robotic device. The MCP angular position measured by the robot and the angle reported on the touchscreen by the subject.
Measured: day 3
Secondary outcomes (21)
sex
man/female
Measured: day 1
Age
age
Measured: day 1
medication use
medication use at time of study
Measured: day 1
the modified Ashworth scale
Spasticity of the upper limb will be evaluated with the modified Ashworth scale
Measured: day 1
Edinburgh Handedness Inventory
Hand Dominance evaluated with Edinburgh Handedness Inventory
Measured: day 1
Nine Hole Peg test
manual dexterity test
Measured: day 1
Box and block test
gross and fine upper limb test
Measured: day 1
Manual Ability Measure-36 (questionnaire)
Patient reported measure for upper limb use in daily life activities
Measured: day 1
Symbol digit modalities test
Cognitive function (Symbol digit modalities test)
Measured: day 1
25 foot walk test
Gait velocity test
Measured: day 1
Semmens-Weinstein monofilaments
Tactile sensitivity in the fingers (Semmens-Weinstein monofilaments)
Measured: day 1
Semmens-Weinstein monofilaments
Tactile sensitivity in the fingers (Semmens-Weinstein monofilaments)
Measured: day 2
Semmens-Weinstein monofilaments
Tactile sensitivity in the fingers (Semmens-Weinstein monofilaments)
Measured: day 3
Rydel Seiffer Tuning fork
Vibration in the upper limb (Rydel Seiffer Tuning fork)
Measured: day 1
Rydel Seiffer Tuning fork
Vibration in the upper limb (Rydel Seiffer Tuning fork)
Measured: day 2
Rydel Seiffer Tuning fork
Vibration in the upper limb (Rydel Seiffer Tuning fork)
Measured: day 3
The Erasmus MC modification of the Nottingham Sensory Assessment (EmNSA)
Sensory function test
Measured: day 1
The Erasmus MC modification of the Nottingham Sensory Assessment (EmNSA)
Sensory function test
Measured: day 2
The Erasmus MC modification of the Nottingham Sensory Assessment (EmNSA)
Sensory function test
Measured: day 3
The System Usability Scale (SUS)
Questionnaire
Measured: day 2
The System Usability Scale (SUS)
questionnaire
Measured: day 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2018
- Study start15 Dec 2017
- Primary completion31 May 2018
- Study completion31 May 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neurological Diseases or ConditionsStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hasselt University
- Sponsor type
- University, hospital or other
- Collaborators
- Jessa Hospital, Revalidatie & MS Centrum Overpelt
- Responsible party
- Principal investigator, Peter Feys, Hasselt University
- Investigators
- peter Feys, prof. dr., Principal investigator, Hasselt UniversityJoke Raats, Study chair, Hasselt UniversityIlse Jamers, Study chair, Hasselt University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03619642
- Sponsor's protocol ID
- proprioception01
- Status last verified
- Sep 2018
- First submitted
- 14 Sep 2017
- Last updated
- 13 Sep 2018
- 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 13 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reliability, Validity and Clinical Utility of a Robotic Assessment of Finger Proprioception in Neurological Subjects
- ClinicalTrials.gov ID
- NCT03619642
- Acronym / sponsor ID
- proprioception01
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Hasselt UniversityUniversity, hospital or other
- Collaborators
- Jessa Hospital, Revalidatie & MS Centrum Overpelt
- Study start
- 15 Dec 2017 (actual)
- Primary completion
- 31 May 2018 (actual)
- Study completion
- 31 May 2018 (actual)
- First posted
- 8 Aug 2018 (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 case-controlled observational cross-sectional study is to investigate the test-retest reliability, validity and clinical utility of a rapid robotic assessment of finger proprioception using a passive gauge position matching tasks in MS and stroke subjects.
Session 1 Informed consent Descriptive measures Session 2 Clinical testing Robotic assessment (3x) Session 3 Clinical testing Robotic assessment (3x)
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| persons with Multiple Sclerosis (MS) | Other | Other: Robotic assessment of finger proprioception25 persons with MS Persons are tested on proprioception of the interphalangeal joints of teh fingers by means of a robotic device. |
| stroke patients | Other | Other: Robotic assessment of finger proprioception25 stroke patients Persons are tested on proprioception of the interphalangeal joints of teh fingers by means of a robotic device. |
| healthy controls | Other | Other: Robotic assessment of finger proprioception50 healthy controls Persons are tested on proprioception of the interphalangeal joints of teh fingers by means of a robotic device. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age > 18 years
- Diagnosis of MS (McDonald criteria)
- No relapse or relapse-related treatment within the last 3 months prior to the study
- Age > 18 years
- Diagnosis of stroke (ischemic or hemorrhagic),
Key exclusion criteria (7 listed)
- Complete paralysis of both upper limbs
- Unable to detect any passive movement in hand and fingers
- Unable to place the hand in the robotic devices without any discomfort or pain
- Marked or severe intention tremor (Fahn's tremor rating scale on finger-to-nose test > 3)
- Marked or severe spasticity for finger and elbow flexors or shoulder adductors (Modified Asworth scale >3)
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 |
|---|---|---|
| Robotic assessment of finger proprioceptionThe assessment will be performed using a robotic device specifically designed for the assessment of finger proprioception at the metacarpophalangeal (MCP) joint . | Other | healthy controls, persons with Multiple Sclerosis (MS), stroke patients |
Primary outcome
Error
Time frame: day 2
The extracted parameter is measured by the robotic device. The MCP angular position measured by the robot and the angle reported on the touchscreen by the subject.
Error
Time frame: day 3
The extracted parameter is measured by the robotic device. The MCP angular position measured by the robot and the angle reported on the touchscreen by the subject.
21 secondary outcomes
sex
Time frame: day 1
Age
Time frame: day 1
medication use
Time frame: day 1
the modified Ashworth scale
Time frame: day 1
Edinburgh Handedness Inventory
Time frame: day 1
Nine Hole Peg test
Time frame: day 1
Box and block test
Time frame: day 1
Manual Ability Measure-36 (questionnaire)
Time frame: day 1
Symbol digit modalities test
Time frame: day 1
25 foot walk test
Time frame: day 1
Semmens-Weinstein monofilaments
Time frame: day 1
Semmens-Weinstein monofilaments
Time frame: day 2
Semmens-Weinstein monofilaments
Time frame: day 3
Rydel Seiffer Tuning fork
Time frame: day 1
Rydel Seiffer Tuning fork
Time frame: day 2
Rydel Seiffer Tuning fork
Time frame: day 3
The Erasmus MC modification of the Nottingham Sensory Assessment (EmNSA)
Time frame: day 1
The Erasmus MC modification of the Nottingham Sensory Assessment (EmNSA)
Time frame: day 2
The Erasmus MC modification of the Nottingham Sensory Assessment (EmNSA)
Time frame: day 3
The System Usability Scale (SUS)
Time frame: day 2
The System Usability Scale (SUS)
Time frame: day 3
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 13 Sep 2018.
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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.
peter Feys, prof. dr. principal investigator
Hasselt University
Joke Raats study chair
Hasselt University
Ilse Jamers study chair
Hasselt University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Robotic assessment of finger proprioception in people with Neurological Diseases or Conditions and Sensory Disorders, run by Hasselt University at 2 sites in Belgium.
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 6 inclusion and 7 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 13 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Belgium. 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?
Error (time frame: day 2). 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?
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 13 Sep 2018.