ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03096977
Recruitment Status : Recruiting
First Posted : March 31, 2017
Last Update Posted : March 31, 2017
Sponsor:
Information provided by (Responsible Party):
Bernard Dachy, Brugmann University Hospital

Brief Summary:
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.

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 : March 2018
Estimated Study Completion Date : March 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.





Primary Outcome Measures :
  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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   20 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • All patients included in the NCT02805634 study

Exclusion Criteria:


Information from the National Library of Medicine

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


Contacts
Contact: Bernard DACHY, MD 32 2 4772446 Bernard.DACHY@chu-brugmann.be

Locations
Belgium
CHU Brugmann Recruiting
Brussel, Belgium, 1020
Contact: Bernard Dachy, MD       Bernard.DACHY@chu-brugmann.be   
Sponsors and Collaborators
Brugmann University Hospital
Investigators
Principal Investigator: Bernard Dachy, MD CHU Brugmann

Responsible Party: Bernard Dachy, Head of Clinic, Brugmann University Hospital
ClinicalTrials.gov Identifier: NCT03096977     History of Changes
Other Study ID Numbers: CHUB-Nine Holes Peg Hands
First Posted: March 31, 2017    Key Record Dates
Last Update Posted: March 31, 2017
Last Verified: March 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Bernard Dachy, Brugmann University Hospital:
Hand dexterity
Multiple sclerosis
Nine Holes Peg

Additional relevant MeSH terms:
Sclerosis
Multiple Sclerosis
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases