NCT05012241

Brief 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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
33

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Sep 2021

Typical duration for all trials

Geographic Reach
1 country

2 active sites

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 12, 2021

Completed
7 days until next milestone

First Posted

Study publicly available on registry

August 19, 2021

Completed
13 days until next milestone

Study Start

First participant enrolled

September 1, 2021

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2022

Completed
2.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2024

Completed
Last Updated

April 30, 2024

Status Verified

April 1, 2024

Enrollment Period

6 months

First QC Date

August 12, 2021

Last Update Submit

April 29, 2024

Conditions

Keywords

occupational therapyfine motor skillsNine Hole Peg Testinter-rater reliabilityvariabilitymultiple sclerosis

Outcome Measures

Primary Outcomes (1)

  • results from the Nine Hole Peg Test

    time in seconds and hundreds of seconds

    10 minutes

Study Arms (1)

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.

Diagnostic Test: Nine Hole Peg Test

Interventions

Nine Hole Peg TestDIAGNOSTIC_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.

Also known as: questionnaire
Czech patients with multiple sclerosis

Eligibility Criteria

Age20 Years - 65 Years
Sexall(Gender-based eligibility)
Gender Eligibility Detailsbased on self-representation
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Czech patients with multiple sclerosis

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Center for Demyelinating Disease (MS center), Department of Neurology, First Faculty of Medicine, Charles University and General University Hospital in Prague

Prague, Czechia

Location

Department of Rehabilitation Medicine, First Faculty of Medicine, Charles University and General University Hospital in Prague

Prague, Czechia

Location

MeSH Terms

Conditions

Motor ActivityMultiple Sclerosis

Interventions

Pain Measurement

Condition Hierarchy (Ancestors)

BehaviorDemyelinating Autoimmune Diseases, CNSAutoimmune Diseases of the Nervous SystemNervous System DiseasesDemyelinating DiseasesAutoimmune DiseasesImmune System Diseases

Intervention Hierarchy (Ancestors)

Neurologic ExaminationPhysical ExaminationDiagnostic Techniques and ProceduresDiagnosis

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
occupational therapist

Study Record Dates

First Submitted

August 12, 2021

First Posted

August 19, 2021

Study Start

September 1, 2021

Primary Completion

February 28, 2022

Study Completion

December 31, 2024

Last Updated

April 30, 2024

Record last verified: 2024-04

Data Sharing

IPD Sharing
Will not share

Locations