Motor ActivityNCT05012241
The Reliability of the Nine Hole Peg Test in Patients With Multiple Sclerosis
An observational study of Motor Activity, run by Charles University, Czech Republic at 2 sites in Czechia.
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. Read more about this study
- Who is it for?
- Ages 20 to 65 years
- Conditions the study is for
- Motor Activity
- What is being tested?
- Nine Hole Peg Test
- How many people
- 33 participants
- Where
- 2 sitesCzechia
- Study dates
- 1 Sep 2021to 31 Dec 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Czech patients with multiple sclerosis
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
Czechia2 sites
Center for Demyelinating Disease (MS center), Department of Neurology, First Faculty of Medicine, Charles University and General University Hospital in Prague
Prague
Department of Rehabilitation Medicine, First Faculty of Medicine, Charles University and General University Hospital in Prague
Prague
About this study
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.
Read the 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.
- Conditions
- Motor Activity
- Being tested
- Nine Hole Peg Test
- Keywords
- occupational therapy, fine motor skills, Nine Hole Peg Test, inter-rater reliability, variability, multiple sclerosis
- Medical subject headings
- Motor Activity, Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nine Hole Peg TestDiagnostic test
Also called questionnaire
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Diagnostic Test: Nine Hole Peg Test |
What is being measured
The primary outcome is the main question the study is designed to answer.
results from the Nine Hole Peg Test
time in seconds and hundreds of seconds
Measured: 10 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2021
- Study start1 Sep 2021
- Primary completion28 Feb 2022
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Motor ActivityStudies of the same condition, open and under way.
- More trials run by Charles University, Czech RepublicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- Charles University, Czech Republic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kateřina Rybářová, Charles University, Czech Republic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05012241
- Sponsor's protocol ID
- 76/21 S-IV
- Status last verified
- Apr 2024
- First submitted
- 12 Aug 2021
- Last updated
- 30 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Reliability of the Nine Hole Peg Test in Patients With Multiple Sclerosis
- ClinicalTrials.gov ID
- NCT05012241
- Acronym / sponsor ID
- 76/21 S-IV
- Conditions
- Motor Activity
- Keywords
- occupational therapy, fine motor skills, Nine Hole Peg Test, inter-rater reliability, variability, multiple sclerosis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 33 participants (actual)
- Lead sponsor
- Charles University, Czech RepublicUniversity, hospital or other
- Study start
- 1 Sep 2021 (actual)
- Primary completion
- 28 Feb 2022 (actual)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 19 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Czech patients with multiple sclerosis | – | Diagnostic Test: Nine Hole Peg TestCzech 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. |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Czech patients with multiple sclerosis
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nine Hole Peg TestAlso: questionnaireAt 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. | Diagnostic test | Czech patients with multiple sclerosis |
Primary outcome
results from the Nine Hole Peg Test
Time frame: 10 minutes
time in seconds and hundreds of seconds
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Motor Activity, run by Charles University, Czech Republic at 2 sites in Czechia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 30 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Czechia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
results from the Nine Hole Peg Test (time frame: 10 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Apr 2024.