- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05012241
The Reliability of the Nine Hole Peg Test in Patients With Multiple Sclerosis
April 29, 2024 updated by: Kateřina Rybářová, Charles University, Czech Republic
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.
Study Overview
Status
Active, not recruiting
Conditions
Intervention / Treatment
Detailed 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.
Study Type
Observational
Enrollment (Actual)
33
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Praha, Czechia
- Department of Rehabilitation Medicine, First Faculty of Medicine, Charles University and General University Hospital in Prague
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Praha, Czechia
- Center for Demyelinating Disease (MS center), Department of Neurology, First Faculty of Medicine, Charles University and General University Hospital in Prague
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
20 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Sampling Method
Non-Probability Sample
Study Population
Czech patients with multiple sclerosis
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Czech patients with multiple sclerosis
Czech patients with multiple sclerosis will be asked to fill in a questionnaire.
Then they will be tested by the Nine Hole Peg Test.
Video of their performance will be obtained.
|
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.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
results from the Nine Hole Peg Test
Time Frame: 10 minutes
|
time in seconds and hundreds of seconds
|
10 minutes
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
September 1, 2021
Primary Completion (Actual)
February 28, 2022
Study Completion (Estimated)
December 31, 2024
Study Registration Dates
First Submitted
August 12, 2021
First Submitted That Met QC Criteria
August 12, 2021
First Posted (Actual)
August 19, 2021
Study Record Updates
Last Update Posted (Estimated)
April 30, 2024
Last Update Submitted That Met QC Criteria
April 29, 2024
Last Verified
April 1, 2024
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 76/21 S-IV
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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