Clinical trial NCT03619642: Reliability, Validity and Clinical Utility of a Robotic Assessment for Proprioception
Official title: Reliability, Validity and Clinical Utility of a Robotic Assessment of Finger Proprioception in Neurological Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Neurological Diseases or Conditions
Sensory Disorders
Multiple Sclerosis
Stroke
Lead sponsor: Hasselt University
Sponsor class: OTHER
Collaborators: name: Jessa Hospital
name: Revalidatie & MS Centrum Overpelt
First posted: 2018-08-08
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief 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.

Session 1 Informed consent Descriptive measures Session 2 Clinical testing Robotic assessment (3x) Session 3 Clinical testing Robotic assessment (3x)


Eligibility criteria: Inclusion Criteria:

Inclusion criteria MS subjects

* Age \> 18 years
* Diagnosis of MS (McDonald criteria)
* No relapse or relapse-related treatment within the last 3 months prior to the study

Inclusion criteria Stroke subjects

* Age \> 18 years
* Diagnosis of stroke (ischemic or hemorrhagic),
* Between 2 weeks and 12 months post-stroke

Exclusion Criteria:

* 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, ...)

Primary outcomes:
measure: Error
timeFrame: day 2
measure: Error
timeFrame: day 3
Secondary outcomes:
measure: sex
timeFrame: day 1
measure: Age
timeFrame: day 1
measure: medication use
timeFrame: day 1
measure: the modified Ashworth scale
timeFrame: day 1
measure: Edinburgh Handedness Inventory
timeFrame: day 1
measure: Nine Hole Peg test
timeFrame: day 1
measure: Box and block test
timeFrame: day 1
measure: Manual Ability Measure-36 (questionnaire)
timeFrame: day 1
measure: Symbol digit modalities test
timeFrame: day 1
measure: 25 foot walk test
timeFrame: day 1
measure: Semmens-Weinstein monofilaments
timeFrame: day 1
measure: Semmens-Weinstein monofilaments
timeFrame: day 2
measure: Semmens-Weinstein monofilaments
timeFrame: day 3
measure: Rydel Seiffer Tuning fork
timeFrame: day 1
measure: Rydel Seiffer Tuning fork
timeFrame: day 2
measure: Rydel Seiffer Tuning fork
timeFrame: day 3
measure: The Erasmus MC modification of the Nottingham Sensory Assessment (EmNSA)
timeFrame: day 1
measure: The Erasmus MC modification of the Nottingham Sensory Assessment (EmNSA)
timeFrame: day 2
measure: The Erasmus MC modification of the Nottingham Sensory Assessment (EmNSA)
timeFrame: day 3
measure: The System Usability Scale (SUS)
timeFrame: day 2
measure: The System Usability Scale (SUS)
timeFrame: day 3
Other outcomes:
Locations:
city: Hasselt
country: Belgium
facility: Jessa Ziekenhuis
city: Overpelt
country: Belgium
facility: Revalidatie & MS Centrum Overpelt
Study officials:
affiliation: Hasselt University
name: peter Feys, prof. dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: Hasselt University
name: Joke Raats
role: STUDY_CHAIR
affiliation: Hasselt University
name: Ilse Jamers
role: STUDY_CHAIR
References: