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Completed

NCT Number: NCT03619642

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

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)

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Key information

Conditions

Neurological Diseases or Conditions Autoimmune Diseases Autoimmune Diseases of the Nervous System Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Demyelinating Autoimmune Diseases, CNS Demyelinating Diseases Immune System Diseases Multiple Sclerosis Nervous System Diseases Neurologic Manifestations Pathological Conditions, Signs and Symptoms Sensation Disorders Sensory Disorders Signs and Symptoms Stroke Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Jessa Ziekenhuis, Hasselt, Belgium

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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, …)

Treatment and study plan

Robotic assessment of finger proprioception

Other

The assessment will be performed using a robotic device specifically designed for the assessment of finger proprioception at the metacarpophalangeal (MCP) joint .

Primary outcomes

  1. Error

    Time frame: day 2

    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.

  2. Error

    Time frame: 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 outcomes

  1. sex

    Time frame: day 1

    man/female

  2. Age

    Time frame: day 1

    age

  3. medication use

    Time frame: day 1

    medication use at time of study

  4. the modified Ashworth scale

    Time frame: day 1

    Spasticity of the upper limb will be evaluated with the modified Ashworth scale

  5. Edinburgh Handedness Inventory

    Time frame: day 1

    Hand Dominance evaluated with Edinburgh Handedness Inventory

  6. Nine Hole Peg test

    Time frame: day 1

    manual dexterity test

  7. Box and block test

    Time frame: day 1

    gross and fine upper limb test

  8. Manual Ability Measure-36 (questionnaire)

    Time frame: day 1

    Patient reported measure for upper limb use in daily life activities

  9. Symbol digit modalities test

    Time frame: day 1

    Cognitive function (Symbol digit modalities test)

  10. 25 foot walk test

    Time frame: day 1

    Gait velocity test

  11. Semmens-Weinstein monofilaments

    Time frame: day 1

    Tactile sensitivity in the fingers (Semmens-Weinstein monofilaments)

  12. Semmens-Weinstein monofilaments

    Time frame: day 2

    Tactile sensitivity in the fingers (Semmens-Weinstein monofilaments)

  13. Semmens-Weinstein monofilaments

    Time frame: day 3

    Tactile sensitivity in the fingers (Semmens-Weinstein monofilaments)

  14. Rydel Seiffer Tuning fork

    Time frame: day 1

    Vibration in the upper limb (Rydel Seiffer Tuning fork)

  15. Rydel Seiffer Tuning fork

    Time frame: day 2

    Vibration in the upper limb (Rydel Seiffer Tuning fork)

  16. Rydel Seiffer Tuning fork

    Time frame: day 3

    Vibration in the upper limb (Rydel Seiffer Tuning fork)

  17. The Erasmus MC modification of the Nottingham Sensory Assessment (EmNSA)

    Time frame: day 1

    Sensory function test

  18. The Erasmus MC modification of the Nottingham Sensory Assessment (EmNSA)

    Time frame: day 2

    Sensory function test

  19. The Erasmus MC modification of the Nottingham Sensory Assessment (EmNSA)

    Time frame: day 3

    Sensory function test

  20. The System Usability Scale (SUS)

    Time frame: day 2

    Questionnaire

  21. The System Usability Scale (SUS)

    Time frame: day 3

    questionnaire

Sponsors and collaborators

Lead sponsor

Hasselt University

Other

Collaborators

  • Jessa Hospital
  • Revalidatie & MS Centrum Overpelt

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Aug 8, 2018
Registry last updated
Sep 13, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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