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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03096977
Other study ID # CHUB-Nine Holes Peg Hands
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date March 15, 2017
Est. completion date January 30, 2019

Study information

Verified date April 2019
Source Brugmann University Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 30
Est. completion date January 30, 2019
Est. primary completion date January 30, 2019
Accepts healthy volunteers No
Gender All
Age group 20 Years to 60 Years
Eligibility Inclusion Criteria:

- All patients included in the NCT02805634 study

Exclusion Criteria:

Study Design


Related Conditions & MeSH terms


Intervention

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
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.
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.
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.

Locations

Country Name City State
Belgium CHU Brugmann Brussel

Sponsors (1)

Lead Sponsor Collaborator
Brugmann University Hospital

Country where clinical trial is conducted

Belgium, 

Outcome

Type Measure Description Time frame Safety issue
Primary Scale for the assessment and rating of ataxia (SARA) Scale for the assessment and rating of ataxia (SARA) 1 year
Primary Prehension force Prehension force, using a JAMAR hand dynamometer 1 year
Primary Tuned fork result Vibratory sensibility testing 1 year
Primary Sermes and Weinstein test Tactile pressure sensation testing 1 year
Primary Weber test Evaluate the discrimination of 2 motionless points 1 year
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