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

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)

Study Overview

• Status: Completed
• Conditions: Stroke; Multiple Sclerosis; Neurological Diseases or Conditions; Sensory Disorders
• Intervention / Treatment: Other: Robotic assessment of finger proprioception

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Belgium
  • Hasselt, Belgium, 3590
    • Jessa Ziekenhuis
  • Overpelt, Belgium
    • Revalidatie & MS Centrum Overpelt

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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, …)

Study Plan

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: persons with Multiple Sclerosis (MS); 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; The assessment will be performed using a robotic device specifically designed for the assessment of finger proprioception at the metacarpophalangeal (MCP) joint .
Other: stroke patients; 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; The assessment will be performed using a robotic device specifically designed for the assessment of finger proprioception at the metacarpophalangeal (MCP) joint .
Other: healthy controls; 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; The assessment will be performed using a robotic device specifically designed for the assessment of finger proprioception at the metacarpophalangeal (MCP) joint .

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

Collaborators and Investigators

• Sponsor: Hasselt University
• Collaborators: Jessa Hospital; Revalidatie & MS Centrum Overpelt
• Investigators: Study Chair: Joke Raats, Hasselt University; Study Chair: Ilse Jamers, Hasselt University

Study record dates

Study Major Dates

• Study Start (Actual): December 15, 2017
• Primary Completion (Actual): May 31, 2018
• Study Completion (Actual): May 31, 2018

Study Registration Dates

• First Submitted: September 14, 2017
• First Submitted That Met QC Criteria: August 2, 2018
• First Posted (Actual): August 8, 2018

Study Record Updates

• Last Update Posted (Actual): September 13, 2018
• Last Update Submitted That Met QC Criteria: September 11, 2018
• Last Verified: September 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Immune System Diseases; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Demyelinating Diseases; Autoimmune Diseases; Neurologic Manifestations; Multiple Sclerosis; Nervous System Diseases; Sensation Disorders
• Other Study ID Numbers: proprioception01

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No