NCT03619642

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)

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 2017

Shorter than P25 for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 14, 2017

Completed
3 months until next milestone

Study Start

First participant enrolled

December 15, 2017

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2018

Completed
2 months until next milestone

First Posted

Study publicly available on registry

August 8, 2018

Completed
Last Updated

September 13, 2018

Status Verified

September 1, 2018

Enrollment Period

6 months

First QC Date

September 14, 2017

Last Update Submit

September 11, 2018

Conditions

Neurological Diseases or ConditionsSensory DisordersMultiple SclerosisStroke

Outcome Measures

Primary Outcomes (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 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 Outcomes (21)

  • sex

    day 1

  • Age

    day 1

  • medication use

    day 1

  • the modified Ashworth scale

    day 1

  • Edinburgh Handedness Inventory

    day 1

  • +16 more secondary outcomes

Study Arms (3)

persons with Multiple Sclerosis (MS)

OTHER

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

stroke patients

OTHER

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

healthy controls

OTHER

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

Interventions

Robotic assessment of finger proprioceptionOTHER

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

healthy controlspersons with Multiple Sclerosis (MS)stroke patients

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age \> 18 years
  • Diagnosis of MS (McDonald criteria)
  • No relapse or relapse-related treatment within the last 3 months prior to the study
  • Age \> 18 years
  • Diagnosis of stroke (ischemic or hemorrhagic),
  • Between 2 weeks and 12 months post-stroke

You may not qualify if:

  • 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, …)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Jessa Ziekenhuis

Hasselt, 3590, Belgium

Location

Revalidatie & MS Centrum Overpelt

Overpelt, Belgium

Location

MeSH Terms

Conditions

Sensation DisordersMultiple SclerosisStroke

Condition Hierarchy (Ancestors)

Neurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsDemyelinating Autoimmune Diseases, CNSAutoimmune Diseases of the Nervous SystemDemyelinating DiseasesAutoimmune DiseasesImmune System DiseasesCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • peter Feys, prof. dr.

    Hasselt University

    PRINCIPAL INVESTIGATOR

  • Joke Raats

    Hasselt University

    STUDY CHAIR

  • Ilse Jamers

    Hasselt University

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

September 14, 2017

First Posted

August 8, 2018

Study Start

December 15, 2017

Primary Completion

May 31, 2018

Study Completion

May 31, 2018

Last Updated

September 13, 2018

Record last verified: 2018-09

Locations

BE(2)