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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT05012241
Other study ID # 76/21 S-IV
Secondary ID
Status Active, not recruiting
Phase
First received
Last updated
Start date September 1, 2021
Est. completion date December 31, 2024

Study information

Verified date April 2024
Source Charles University, Czech Republic
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The main aim of the project is to establish inter-rater reliability, internal variability and variability of results got in two different ways of the Nine Hole Peg Test administered according to the new Czech extended version manual in patients with multiple sclerosis.


Description:

At least 30 patients with multiple sclerosis will be tested by Nine Hole Peg Test according to new Czech manual for this test. The testing will take place in one session. Video of patients' performance will be obtained. The inter-rater reliability, internal variability and variability of results got in two different ways will be established.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 33
Est. completion date December 31, 2024
Est. primary completion date February 28, 2022
Accepts healthy volunteers No
Gender All
Age group 20 Years to 65 Years
Eligibility Inclusion Criteria: - outpatients with clinically definite multiple sclerosis - Czech language as a mother tongue - age from 20 to 65 years - clinically stable disease (more than 30 days since the last attack of the disease) - Expanded Disability Status Scale (EDSS) score between 1.5-8.0 Exclusion Criteria: - inability to complete the test attempt of the Nine Hole Peg Test - vision impairment uncorrectable with glasses - severe hearing loss - inability to understand instructions - inability to complete complete testing - failure to sign Informed consent for the patient and Consent to the collection and processing of personal data during the study at the General University Hospital in Prague

Study Design


Related Conditions & MeSH terms


Intervention

Diagnostic Test:
Nine Hole Peg Test
At first, each patient will be asked to fill in the questionnaire. Then he/she will be tested by the Nine Hole Peg Test according to the new Czech version of extended manual for this test. Audio recording of verbal instructions will be used.

Locations

Country Name City State
Czechia Center for Demyelinating Disease (MS center), Department of Neurology, First Faculty of Medicine, Charles University and General University Hospital in Prague Praha
Czechia Department of Rehabilitation Medicine, First Faculty of Medicine, Charles University and General University Hospital in Prague Praha

Sponsors (1)

Lead Sponsor Collaborator
Charles University, Czech Republic

Country where clinical trial is conducted

Czechia, 

Outcome

Type Measure Description Time frame Safety issue
Primary results from the Nine Hole Peg Test time in seconds and hundreds of seconds 10 minutes
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