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

Primary Purpose

Neurological Diseases or Conditions, Sensory Disorders, Multiple Sclerosis

Status
Completed
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
Robotic assessment of finger proprioception
Sponsored by
Hasselt University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Neurological Diseases or Conditions

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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, …)

Sites / Locations

  • Jessa Ziekenhuis
  • Revalidatie & MS Centrum Overpelt

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Other

Other

Other

Arm Label

persons with Multiple Sclerosis (MS)

stroke patients

healthy controls

Arm Description

25 persons with MS Persons are tested on proprioception of the interphalangeal joints of teh fingers by means of a robotic device.

25 stroke patients Persons are tested on proprioception of the interphalangeal joints of teh fingers by means of a robotic device.

50 healthy controls Persons are tested on proprioception of the interphalangeal joints of teh fingers by means of a robotic device.

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

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

Full Information

First Posted
September 14, 2017
Last Updated
September 11, 2018
Sponsor
Hasselt University
Collaborators
Jessa Hospital, Revalidatie & MS Centrum Overpelt
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1. Study Identification

Unique Protocol Identification Number
NCT03619642
Brief Title
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

2. Study Status

Record Verification Date
September 2018
Overall Recruitment Status
Completed
Study Start Date
December 15, 2017 (Actual)
Primary Completion Date
May 31, 2018 (Actual)
Study Completion Date
May 31, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hasselt University
Collaborators
Jessa Hospital, Revalidatie & MS Centrum Overpelt

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neurological Diseases or Conditions, Sensory Disorders, Multiple Sclerosis, Stroke

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
persons with Multiple Sclerosis (MS)
Arm Type
Other
Arm Description
25 persons with MS Persons are tested on proprioception of the interphalangeal joints of teh fingers by means of a robotic device.
Arm Title
stroke patients
Arm Type
Other
Arm Description
25 stroke patients Persons are tested on proprioception of the interphalangeal joints of teh fingers by means of a robotic device.
Arm Title
healthy controls
Arm Type
Other
Arm Description
50 healthy controls Persons are tested on proprioception of the interphalangeal joints of teh fingers by means of a robotic device.
Intervention Type
Other
Intervention Name(s)
Robotic assessment of finger proprioception
Intervention Description
The assessment will be performed using a robotic device specifically designed for the assessment of finger proprioception at the metacarpophalangeal (MCP) joint .
Primary Outcome Measure Information:
Title
Error
Description
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.
Time Frame
day 2
Title
Error
Description
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.
Time Frame
day 3
Secondary Outcome Measure Information:
Title
sex
Description
man/female
Time Frame
day 1
Title
Age
Description
age
Time Frame
day 1
Title
medication use
Description
medication use at time of study
Time Frame
day 1
Title
the modified Ashworth scale
Description
Spasticity of the upper limb will be evaluated with the modified Ashworth scale
Time Frame
day 1
Title
Edinburgh Handedness Inventory
Description
Hand Dominance evaluated with Edinburgh Handedness Inventory
Time Frame
day 1
Title
Nine Hole Peg test
Description
manual dexterity test
Time Frame
day 1
Title
Box and block test
Description
gross and fine upper limb test
Time Frame
day 1
Title
Manual Ability Measure-36 (questionnaire)
Description
Patient reported measure for upper limb use in daily life activities
Time Frame
day 1
Title
Symbol digit modalities test
Description
Cognitive function (Symbol digit modalities test)
Time Frame
day 1
Title
25 foot walk test
Description
Gait velocity test
Time Frame
day 1
Title
Semmens-Weinstein monofilaments
Description
Tactile sensitivity in the fingers (Semmens-Weinstein monofilaments)
Time Frame
day 1
Title
Semmens-Weinstein monofilaments
Description
Tactile sensitivity in the fingers (Semmens-Weinstein monofilaments)
Time Frame
day 2
Title
Semmens-Weinstein monofilaments
Description
Tactile sensitivity in the fingers (Semmens-Weinstein monofilaments)
Time Frame
day 3
Title
Rydel Seiffer Tuning fork
Description
Vibration in the upper limb (Rydel Seiffer Tuning fork)
Time Frame
day 1
Title
Rydel Seiffer Tuning fork
Description
Vibration in the upper limb (Rydel Seiffer Tuning fork)
Time Frame
day 2
Title
Rydel Seiffer Tuning fork
Description
Vibration in the upper limb (Rydel Seiffer Tuning fork)
Time Frame
day 3
Title
The Erasmus MC modification of the Nottingham Sensory Assessment (EmNSA)
Description
Sensory function test
Time Frame
day 1
Title
The Erasmus MC modification of the Nottingham Sensory Assessment (EmNSA)
Description
Sensory function test
Time Frame
day 2
Title
The Erasmus MC modification of the Nottingham Sensory Assessment (EmNSA)
Description
Sensory function test
Time Frame
day 3
Title
The System Usability Scale (SUS)
Description
Questionnaire
Time Frame
day 2
Title
The System Usability Scale (SUS)
Description
questionnaire
Time Frame
day 3

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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, …)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
peter Feys, prof. dr.
Organizational Affiliation
Hasselt University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Joke Raats
Organizational Affiliation
Hasselt University
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Ilse Jamers
Organizational Affiliation
Hasselt University
Official's Role
Study Chair
Facility Information:
Facility Name
Jessa Ziekenhuis
City
Hasselt
ZIP/Postal Code
3590
Country
Belgium
Facility Name
Revalidatie & MS Centrum Overpelt
City
Overpelt
Country
Belgium

12. IPD Sharing Statement

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

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