NCT05009121

Brief Summary

The main aim of the pilot project is to establish inter-rater reliability, internal variability and variability of results got in Box and Block Test administered according to the new Czech extended version of its manual.

Trial Health

55
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started May 2021

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
active not recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 31, 2021

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

August 12, 2021

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 17, 2021

Completed
7 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 30, 2024

Completed
Last Updated

April 30, 2024

Status Verified

April 1, 2024

Enrollment Period

9 months

First QC Date

August 12, 2021

Last Update Submit

April 29, 2024

Conditions

Keywords

standardized testoccupational therapyfine motor skillsBox and Block Testinter-rater reliabilityvariabilityCzech languageStroke

Outcome Measures

Primary Outcomes (1)

  • results from the Box and Block Test

    number of transported blocks

    30 minutes

Study Arms (1)

Czech adult people after stroke

Czech adult people after stroke will be asked basic questions about present feelings according to their condition using a questionnaire. Then they will be tested by the Box and Block Test in only one session. Video of their performance will be obtained. The Box and Block Test will be done during their regular rehabilitation by occupational therapist.

Diagnostic Test: Box and Block Test

Interventions

Box and Block TestDIAGNOSTIC_TEST

At first, each person will be asked basic questions about present feelings according to their condition using a questionnaire. Than he/she will be tested by the Box and Block Test according to the Czech version of extended manual for this test in only one session. Audio recording of verbal instructions will be used. The results will be used only for establishing of the variability and inter-rater reliability of the Box and Block Test, not for patients' other interventions.

Also known as: questionnaire
Czech adult people after stroke

Eligibility Criteria

Age18 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 adult people after stroke

You may qualify if:

  • Czech language as a mother tongue
  • Adult (age 18 and more)
  • Patient after Stroke attending the Department of Rehabilitation Medicine, First Faculty of Medicine, Charles University and General University Hospital in Prague
  • Able to move 25mm X 25mm block at least by 10 cm
  • Able to complete testing with full 3 attempts
  • Able to sit for 20 minutes

You may not qualify if:

  • use of drugs affecting attention
  • vision impairment uncorrectable with glasses
  • severe hearing loss
  • inability to understand instructions
  • inability to complete testing

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Prague, Czechia

Location

MeSH Terms

Conditions

Motor ActivityStroke

Interventions

Pain Measurement

Condition Hierarchy (Ancestors)

BehaviorCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular 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 17, 2021

Study Start

May 31, 2021

Primary Completion

February 28, 2022

Study Completion

December 30, 2024

Last Updated

April 30, 2024

Record last verified: 2024-04

Data Sharing

IPD Sharing
Will not share

Locations