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

Not Applicable

Completed

• Conditions: Multiple Sclerosis; Neurological Diseases or Conditions; Sensory Disorders; Stroke

• Registration Number: NCT03619642
• Lead Sponsor: Hasselt University

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)

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-09-14
• Study Start: 2017-12-15
• Primary Completion: 2018-05-31
• Study Completion: 2018-05-31
• Study First Submitted QC: 2018-08-02
• Study First Posted: 2018-08-08
• Status Verified: 2018-09
• Last Update Submitted: 2018-09-11
• Last Update Posted: 2018-09-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Error	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.

Secondary Outcome Measures

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

Trial Locations

Locations (2)

Jessa Ziekenhuis; 🇧🇪 Hasselt, Belgium

Revalidatie & MS Centrum Overpelt; 🇧🇪 Overpelt, Belgium