Use of the Nine Holes Peg Test in Multiple Sclerosis: Participation of Elementary Neurological Components in the Functional Evaluation of Manual Dexterity

NCT ID: NCT03096977

Last Updated: 2019-04-17

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

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-03-15

Study Completion Date

2019-01-30

Brief Summary

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This study lies in the continuity of the study with identification number NCT02805634. It will be performed on the same group of patients and will aim to assess the manual dexterity, in order to better assign kinesitherapy treatments and increase the utilisation capacity of the hand.

Detailed Description

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Conditions

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Multiple Sclerosis

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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CHUB-TST02 patients

All patients who participated in the NCT02805634 (CHUB-TST02) study.

Group Type EXPERIMENTAL

Scale for the assessment and rating of ataxia (SARA)

Intervention Type DIAGNOSTIC_TEST

Clinical evaluation of the manual dexterity through the SARA scale.

JAMAR hand dynamometer

Intervention Type DEVICE

Clinical evaluation of the prehension force using a JAMAR Dynamometer.

The prehension effort is made with the arm along the body, forearm horizontal, elbow flexed at 90 degrees, wrist in neutral position. The handle of the dynamometer is set to the second notch. The effort required is maximum effort.

Verbal encouragement is given during four successive tentative: the last three are averaged.

Each effort will be separated by a rest period of one minute. Interval: 1 min - Repeat: 3 times per hand

Vibratory sensibility testing

Intervention Type DEVICE

Test carried out using a tuned fork applied to the styloid radial process.

Position of the evaluated: elbow to the body with forearms horizontal and the wrist in neutral position. Stimulate the tuning fork and apply it to the styloid process of the radius. Ask the patient to say when he no longer feels the vibration.

Repeat 3 times for each hand.

Sermes and Weinstein test

Intervention Type DEVICE

Instrumental, quantitative method of tactile pressure sensation (dermal contact at constant pressure) using monofilaments. The monofilaments bend when a threshold force is applied to them.There is a kit of 5 monofilaments, each one corresponding to a different functional level.

Familiarize the patient with the test, eyes open, on a normal healthy side. Determine the level of perception of the healthy side, eyes closed. Start with the finest monofilament. If the answer is negative, go to the next monofilament.

The monofilaments applications are randomly made in the Wynn Parry areas, 3 times / area for blue and green filaments, then 1 time / zone for others.

The monofilament must be applied in 1.5 sec, held 1.5 sec, removed in 1.5 sec. The patient must give a verbal response "yes" when he perceives the contact and the response time must be less than 3 sec.

Weber test

Intervention Type DEVICE

Evaluate the discrimination of 2 motionless points. The tactile discrimination threshold is the smallest distance separating 2 simultaneous stimulations that are located and perceived separately.

The pressure stops at the whitening of the skin. The patient should specify if he feels one or two spikes.

To determine the discrimination threshold:

Perform 10 stimulations of the same spacing in the same area. The smallest interval for which 7 correct answers are obtained is retained as threshold value.

Perform the test 3 times.

Interventions

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Scale for the assessment and rating of ataxia (SARA)

Clinical evaluation of the manual dexterity through the SARA scale.

Intervention Type DIAGNOSTIC_TEST

JAMAR hand dynamometer

Clinical evaluation of the prehension force using a JAMAR Dynamometer.

The prehension effort is made with the arm along the body, forearm horizontal, elbow flexed at 90 degrees, wrist in neutral position. The handle of the dynamometer is set to the second notch. The effort required is maximum effort.

Verbal encouragement is given during four successive tentative: the last three are averaged.

Each effort will be separated by a rest period of one minute. Interval: 1 min - Repeat: 3 times per hand

Intervention Type DEVICE

Vibratory sensibility testing

Test carried out using a tuned fork applied to the styloid radial process.

Position of the evaluated: elbow to the body with forearms horizontal and the wrist in neutral position. Stimulate the tuning fork and apply it to the styloid process of the radius. Ask the patient to say when he no longer feels the vibration.

Repeat 3 times for each hand.

Intervention Type DEVICE

Sermes and Weinstein test

Instrumental, quantitative method of tactile pressure sensation (dermal contact at constant pressure) using monofilaments. The monofilaments bend when a threshold force is applied to them.There is a kit of 5 monofilaments, each one corresponding to a different functional level.

Familiarize the patient with the test, eyes open, on a normal healthy side. Determine the level of perception of the healthy side, eyes closed. Start with the finest monofilament. If the answer is negative, go to the next monofilament.

The monofilaments applications are randomly made in the Wynn Parry areas, 3 times / area for blue and green filaments, then 1 time / zone for others.

The monofilament must be applied in 1.5 sec, held 1.5 sec, removed in 1.5 sec. The patient must give a verbal response "yes" when he perceives the contact and the response time must be less than 3 sec.

Intervention Type DEVICE

Weber test

Evaluate the discrimination of 2 motionless points. The tactile discrimination threshold is the smallest distance separating 2 simultaneous stimulations that are located and perceived separately.

The pressure stops at the whitening of the skin. The patient should specify if he feels one or two spikes.

To determine the discrimination threshold:

Perform 10 stimulations of the same spacing in the same area. The smallest interval for which 7 correct answers are obtained is retained as threshold value.

Perform the test 3 times.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* All patients included in the NCT02805634 study

Exclusion Criteria

* None
Minimum Eligible Age

20 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Brugmann University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Bernard Dachy

Head of Clinic

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Bernard Dachy, MD

Role: PRINCIPAL_INVESTIGATOR

CHU Brugmann

Locations

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CHU Brugmann

Brussels, , Belgium

Site Status

Countries

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Belgium

Other Identifiers

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CHUB-Nine Holes Peg Hands

Identifier Type: -

Identifier Source: org_study_id

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