NCT03096977

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at P25-P50 for not_applicable multiple-sclerosis

Timeline
Completed

Started Mar 2017

Typical duration for not_applicable multiple-sclerosis

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 15, 2017

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

March 24, 2017

Completed
7 days until next milestone

First Posted

Study publicly available on registry

March 31, 2017

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 30, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 30, 2019

Completed
Last Updated

April 17, 2019

Status Verified

April 1, 2019

Enrollment Period

1.9 years

First QC Date

March 24, 2017

Last Update Submit

April 16, 2019

Conditions

Keywords

Hand dexterityMultiple sclerosisNine Holes Peg

Outcome Measures

Primary Outcomes (5)

  • Scale for the assessment and rating of ataxia (SARA)

    Scale for the assessment and rating of ataxia (SARA)

    1 year

  • Prehension force

    Prehension force, using a JAMAR hand dynamometer

    1 year

  • Tuned fork result

    Vibratory sensibility testing

    1 year

  • Sermes and Weinstein test

    Tactile pressure sensation testing

    1 year

  • Weber test

    Evaluate the discrimination of 2 motionless points

    1 year

Study Arms (1)

CHUB-TST02 patients

EXPERIMENTAL

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

Diagnostic Test: Scale for the assessment and rating of ataxia (SARA)Device: JAMAR hand dynamometerDevice: Vibratory sensibility testingDevice: Sermes and Weinstein testDevice: Weber test

Interventions

Clinical evaluation of the manual dexterity through the SARA scale.

CHUB-TST02 patients

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

CHUB-TST02 patients

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.

CHUB-TST02 patients

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.

CHUB-TST02 patients

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.

CHUB-TST02 patients

Eligibility Criteria

Age20 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • All patients included in the NCT02805634 study

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU Brugmann

Brussels, 1020, Belgium

Location

MeSH Terms

Conditions

Multiple Sclerosis

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNSAutoimmune Diseases of the Nervous SystemNervous System DiseasesDemyelinating DiseasesAutoimmune DiseasesImmune System Diseases

Study Officials

  • Bernard Dachy, MD

    CHU Brugmann

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head of Clinic

Study Record Dates

First Submitted

March 24, 2017

First Posted

March 31, 2017

Study Start

March 15, 2017

Primary Completion

January 30, 2019

Study Completion

January 30, 2019

Last Updated

April 17, 2019

Record last verified: 2019-04

Data Sharing

IPD Sharing
Will not share

Locations