Reliability, Validity and Clinical Utility of a Robotic Assessment for Proprioception

Study Overview
=================
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)

Official Title
-----------------
Reliability, Validity and Clinical Utility of a Robotic Assessment of Finger Proprioception in Neurological Subjects

Conditions
-----------------
Neurological Diseases or Conditions, Sensory Disorders, Multiple Sclerosis, Stroke

Intervention / Treatment
-----------------
* Other: Robotic assessment of finger proprioception


Participation Criteria
=================
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, …)

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Other
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: persons with Multiple Sclerosis (MS)<br>25 persons with MS Persons are tested on proprioception of the interphalangeal joints of teh fingers by means of a robotic device. | Other: Robotic assessment of finger proprioception<br>* The assessment will be performed using a robotic device specifically designed for the assessment of finger proprioception at the metacarpophalangeal (MCP) joint .<br>|
| Other: stroke patients<br>25 stroke patients Persons are tested on proprioception of the interphalangeal joints of teh fingers by means of a robotic device. | Other: Robotic assessment of finger proprioception<br>* The assessment will be performed using a robotic device specifically designed for the assessment of finger proprioception at the metacarpophalangeal (MCP) joint .<br>|
| Other: healthy controls<br>50 healthy controls Persons are tested on proprioception of the interphalangeal joints of teh fingers by means of a robotic device. | Other: Robotic assessment of finger proprioception<br>* The assessment will be performed using a robotic device specifically designed for the assessment of finger proprioception at the metacarpophalangeal (MCP) joint .<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | day 3 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| sex | man/female | day 1 | 
| Age | age | day 1 | 
| medication use | medication use at time of study | day 1 | 
| the modified Ashworth scale | Spasticity of the upper limb will be evaluated with the modified Ashworth scale | day 1 | 
| Edinburgh Handedness Inventory | Hand Dominance evaluated with Edinburgh Handedness Inventory | day 1 | 
| Nine Hole Peg test | manual dexterity test | day 1 | 
| Box and block test | gross and fine upper limb test | day 1 | 
| Manual Ability Measure-36 (questionnaire) | Patient reported measure for upper limb use in daily life activities | day 1 | 
| Symbol digit modalities test | Cognitive function (Symbol digit modalities test) | day 1 | 
| 25 foot walk test | Gait velocity test | day 1 | 
| Semmens-Weinstein monofilaments | Tactile sensitivity in the fingers (Semmens-Weinstein monofilaments) | day 1 | 
| Semmens-Weinstein monofilaments | Tactile sensitivity in the fingers (Semmens-Weinstein monofilaments) | day 2 | 
| Semmens-Weinstein monofilaments | Tactile sensitivity in the fingers (Semmens-Weinstein monofilaments) | day 3 | 
| Rydel Seiffer Tuning fork | Vibration in the upper limb (Rydel Seiffer Tuning fork) | day 1 | 
| Rydel Seiffer Tuning fork | Vibration in the upper limb (Rydel Seiffer Tuning fork) | day 2 | 
| Rydel Seiffer Tuning fork | Vibration in the upper limb (Rydel Seiffer Tuning fork) | day 3 | 
| The Erasmus MC modification of the Nottingham Sensory Assessment (EmNSA) | Sensory function test | day 1 | 
| The Erasmus MC modification of the Nottingham Sensory Assessment (EmNSA) | Sensory function test | day 2 | 
| The Erasmus MC modification of the Nottingham Sensory Assessment (EmNSA) | Sensory function test | day 3 | 
| The System Usability Scale (SUS) | Questionnaire | day 2 | 
| The System Usability Scale (SUS) | questionnaire | day 3 |