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

Stroke Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03619642
• Other study ID #: proprioception01
• Status: Completed
• Phase: N/A
• Start date: December 15, 2017
• Est. completion date: May 31, 2018

Study information

• Verified date: September 2018
• Source: Hasselt University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: May 31, 2018
• Est. primary completion date: May 31, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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, …)

Related Conditions & MeSH terms

• Multiple Sclerosis
• Nervous System Diseases
• Neurological Diseases or Conditions
• Sensation Disorders
• Sensory Disorders
• Stroke

Intervention

Other:
• 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 .

Locations

Country	Name	City	State
Belgium	Jessa Ziekenhuis	Hasselt
Belgium	Revalidatie & MS Centrum Overpelt	Overpelt

Sponsors (3)

Lead Sponsor	Collaborator
Hasselt University	Jessa Hospital, Revalidatie and MS Centrum Overpelt

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	sex	man/female	day 1
Secondary	Age	age	day 1
Secondary	medication use	medication use at time of study	day 1
Secondary	the modified Ashworth scale	Spasticity of the upper limb will be evaluated with the modified Ashworth scale	day 1
Secondary	Edinburgh Handedness Inventory	Hand Dominance evaluated with Edinburgh Handedness Inventory	day 1
Secondary	Nine Hole Peg test	manual dexterity test	day 1
Secondary	Box and block test	gross and fine upper limb test	day 1
Secondary	Manual Ability Measure-36 (questionnaire)	Patient reported measure for upper limb use in daily life activities	day 1
Secondary	Symbol digit modalities test	Cognitive function (Symbol digit modalities test)	day 1
Secondary	25 foot walk test	Gait velocity test	day 1
Secondary	Semmens-Weinstein monofilaments	Tactile sensitivity in the fingers (Semmens-Weinstein monofilaments)	day 1
Secondary	Semmens-Weinstein monofilaments	Tactile sensitivity in the fingers (Semmens-Weinstein monofilaments)	day 2
Secondary	Semmens-Weinstein monofilaments	Tactile sensitivity in the fingers (Semmens-Weinstein monofilaments)	day 3
Secondary	Rydel Seiffer Tuning fork	Vibration in the upper limb (Rydel Seiffer Tuning fork)	day 1
Secondary	Rydel Seiffer Tuning fork	Vibration in the upper limb (Rydel Seiffer Tuning fork)	day 2
Secondary	Rydel Seiffer Tuning fork	Vibration in the upper limb (Rydel Seiffer Tuning fork)	day 3
Secondary	The Erasmus MC modification of the Nottingham Sensory Assessment (EmNSA)	Sensory function test	day 1
Secondary	The Erasmus MC modification of the Nottingham Sensory Assessment (EmNSA)	Sensory function test	day 2
Secondary	The Erasmus MC modification of the Nottingham Sensory Assessment (EmNSA)	Sensory function test	day 3
Secondary	The System Usability Scale (SUS)	Questionnaire	day 2
Secondary	The System Usability Scale (SUS)	questionnaire	day 3