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

Primary Purpose

Multiple Sclerosis

Status
Completed
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
Scale for the assessment and rating of ataxia (SARA)
JAMAR hand dynamometer
Vibratory sensibility testing
Sermes and Weinstein test
Weber test
Sponsored by
Brugmann University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Multiple Sclerosis focused on measuring Hand dexterity, Multiple sclerosis, Nine Holes Peg

Eligibility Criteria

20 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • All patients included in the NCT02805634 study

Exclusion Criteria:

  • None

Sites / Locations

  • CHU Brugmann

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

CHUB-TST02 patients

Arm Description

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

Outcomes

Primary Outcome Measures

Scale for the assessment and rating of ataxia (SARA)
Scale for the assessment and rating of ataxia (SARA)
Prehension force
Prehension force, using a JAMAR hand dynamometer
Tuned fork result
Vibratory sensibility testing
Sermes and Weinstein test
Tactile pressure sensation testing
Weber test
Evaluate the discrimination of 2 motionless points

Secondary Outcome Measures

Full Information

First Posted
March 24, 2017
Last Updated
April 16, 2019
Sponsor
Brugmann University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03096977
Brief Title
Use of the Nine Holes Peg Test in Multiple Sclerosis: Participation of Elementary Neurological Components in the Functional Evaluation of Manual Dexterity
Official Title
Use of the Nine Holes Peg Test in Multiple Sclerosis: Participation of Elementary Neurological Components in the Functional Evaluation of Manual Dexterity
Study Type
Interventional

2. Study Status

Record Verification Date
April 2019
Overall Recruitment Status
Completed
Study Start Date
March 15, 2017 (Actual)
Primary Completion Date
January 30, 2019 (Actual)
Study Completion Date
January 30, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Brugmann University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Sclerosis
Keywords
Hand dexterity, Multiple sclerosis, Nine Holes Peg

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
CHUB-TST02 patients
Arm Type
Experimental
Arm Description
All patients who participated in the NCT02805634 (CHUB-TST02) study.
Intervention Type
Diagnostic Test
Intervention Name(s)
Scale for the assessment and rating of ataxia (SARA)
Intervention Description
Clinical evaluation of the manual dexterity through the SARA scale.
Intervention Type
Device
Intervention Name(s)
JAMAR hand dynamometer
Intervention Description
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
Intervention Name(s)
Vibratory sensibility testing
Intervention Description
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
Intervention Name(s)
Sermes and Weinstein test
Intervention Description
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
Intervention Name(s)
Weber test
Intervention Description
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 Measure Information:
Title
Scale for the assessment and rating of ataxia (SARA)
Description
Scale for the assessment and rating of ataxia (SARA)
Time Frame
1 year
Title
Prehension force
Description
Prehension force, using a JAMAR hand dynamometer
Time Frame
1 year
Title
Tuned fork result
Description
Vibratory sensibility testing
Time Frame
1 year
Title
Sermes and Weinstein test
Description
Tactile pressure sensation testing
Time Frame
1 year
Title
Weber test
Description
Evaluate the discrimination of 2 motionless points
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: All patients included in the NCT02805634 study Exclusion Criteria: None
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bernard Dachy, MD
Organizational Affiliation
CHU Brugmann
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU Brugmann
City
Brussel
ZIP/Postal Code
1020
Country
Belgium

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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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