Use of the Nine Holes Peg Test in Multiple Sclerosis: Participation of Elementary Neurological Components in the Functional Evaluation of Manual Dexterity
1 other identifier
interventional
30
1 country
1
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
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable multiple-sclerosis
Started Mar 2017
Typical duration for not_applicable multiple-sclerosis
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 15, 2017
CompletedFirst Submitted
Initial submission to the registry
March 24, 2017
CompletedFirst Posted
Study publicly available on registry
March 31, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 30, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
January 30, 2019
CompletedApril 17, 2019
April 1, 2019
1.9 years
March 24, 2017
April 16, 2019
Conditions
Keywords
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
EXPERIMENTALAll patients who participated in the NCT02805634 (CHUB-TST02) study.
Interventions
Clinical evaluation of the manual dexterity through the SARA scale.
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
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.
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.
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.
Eligibility Criteria
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
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Bernard Dachy, MD
CHU Brugmann
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