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Completed

NCT Number: NCT03096977

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

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.

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Key information

Age range

20 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHU Brugmann

Brussels, 1020, Belgium

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • All patients included in the NCT02805634 study

Exclusion criteria

  • None

Treatment and study plan

Scale for the assessment and rating of ataxia (SARA)

Diagnostic Test

Clinical evaluation of the manual dexterity through the SARA scale.

JAMAR hand dynamometer

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

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

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

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.

Primary outcomes

  1. Scale for the assessment and rating of ataxia (SARA)

    Time frame: 1 year

    Scale for the assessment and rating of ataxia (SARA)

  2. Prehension force

    Time frame: 1 year

    Prehension force, using a JAMAR hand dynamometer

  3. Tuned fork result

    Time frame: 1 year

    Vibratory sensibility testing

  4. Sermes and Weinstein test

    Time frame: 1 year

    Tactile pressure sensation testing

  5. Weber test

    Time frame: 1 year

    Evaluate the discrimination of 2 motionless points

Sponsors and collaborators

Lead sponsor

Brugmann University Hospital

Other

Registry information

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Mar 31, 2017
Registry last updated
Apr 17, 2019

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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