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

NCT ID: NCT03619642

Last Updated: 2018-09-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-12-15

Study Completion Date

2018-05-31

Brief Summary

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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

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Conditions

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Neurological Diseases or Conditions Sensory Disorders Multiple Sclerosis Stroke

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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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.

Group Type OTHER

Robotic assessment of finger proprioception

Intervention Type OTHER

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

stroke patients

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

Group Type OTHER

Robotic assessment of finger proprioception

Intervention Type OTHER

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

healthy controls

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

Group Type OTHER

Robotic assessment of finger proprioception

Intervention Type OTHER

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

Interventions

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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 .

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* 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

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, …)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Jessa Hospital

OTHER

Sponsor Role collaborator

Revalidatie & MS Centrum Overpelt

OTHER

Sponsor Role collaborator

Hasselt University

OTHER

Sponsor Role lead

Responsible Party

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Peter Feys

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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peter Feys, prof. dr.

Role: PRINCIPAL_INVESTIGATOR

Hasselt University

Joke Raats

Role: STUDY_CHAIR

Hasselt University

Ilse Jamers

Role: STUDY_CHAIR

Hasselt University

Locations

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Jessa Ziekenhuis

Hasselt, , Belgium

Site Status

Revalidatie & MS Centrum Overpelt

Overpelt, , Belgium

Site Status

Countries

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Belgium

Other Identifiers

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proprioception01

Identifier Type: -

Identifier Source: org_study_id

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