Use of the Nine Holes Peg Test in Multiple Sclerosis: Participation of Elementary Neurological Components in the Functional Evaluation of Manual Dexterity
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|ClinicalTrials.gov Identifier: NCT03096977|
Recruitment Status : Recruiting
First Posted : March 31, 2017
Last Update Posted : July 12, 2018
|Condition or disease||Intervention/treatment||Phase|
|Multiple Sclerosis||Diagnostic Test: Scale for the assessment and rating of ataxia (SARA) Device: JAMAR hand dynamometer Device: Vibratory sensibility testing Device: Sermes and Weinstein test Device: Weber test||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Supportive Care|
|Official Title:||Use of the Nine Holes Peg Test in Multiple Sclerosis: Participation of Elementary Neurological Components in the Functional Evaluation of Manual Dexterity|
|Actual Study Start Date :||March 15, 2017|
|Estimated Primary Completion Date :||January 2020|
|Estimated Study Completion Date :||January 2020|
Experimental: CHUB-TST02 patients
All patients who participated in the NCT02805634 (CHUB-TST02) study.
Diagnostic Test: Scale for the assessment and rating of ataxia (SARA)
Clinical evaluation of the manual dexterity through the SARA scale.
Device: 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
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.
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.
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.
- Scale for the assessment and rating of ataxia (SARA) [ Time Frame: 1 year ]Scale for the assessment and rating of ataxia (SARA)
- Prehension force [ Time Frame: 1 year ]Prehension force, using a JAMAR hand dynamometer
- Tuned fork result [ Time Frame: 1 year ]Vibratory sensibility testing
- Sermes and Weinstein test [ Time Frame: 1 year ]Tactile pressure sensation testing
- Weber test [ Time Frame: 1 year ]Evaluate the discrimination of 2 motionless points
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03096977
|Contact: Bernard DACHY, MD||32 2 4772446||Bernard.DACHY@chu-brugmann.be|
|Brussel, Belgium, 1020|
|Contact: Bernard Dachy, MD Bernard.DACHY@chu-brugmann.be|
|Principal Investigator:||Bernard Dachy, MD||CHU Brugmann|