Motor ActivityNCT05009121
The Reliability of the Box and Block Test in People After Stroke
An observational study of Motor Activity, run by Charles University, Czech Republic at 1 site in Czechia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Motor Activity
- What is being tested?
- Box and Block Test
- How many people
- 20 participants
- Where
- 1 siteCzechia
- Study dates
- 31 May 2021to 30 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Czech adult people after stroke
Who may be able to join
- 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
Who cannot join
- use of drugs affecting attention
- vision impairment uncorrectable with glasses
- severe hearing loss
- inability to understand instructions
- inability to complete testing
- failure to sign Informed consent for probation with inclusion to research and Consent to the collection and processing of personal data during the study at the General University Hospital in Prague
Trial locations and contacts
1 site in 1 country.
Czechia1 site
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 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.
Read the detailed description
New Czech manual for the Box and Block Test was made by back-translation method. It was updated and extended by new rules for unification of it´s performing. The manual include instructions for performing three trials.
At least 20 adult people after stroke will be tested by this test according to this new Czech manual. Video of patients' performance will be obtained.
The inter-rater reliability, internal variability and variability of results will be established.
- Conditions
- Motor Activity
- Being tested
- Box and Block Test
- Keywords
- standardized test, occupational therapy, fine motor skills, Box and Block Test, inter-rater reliability, variability, Czech language, Stroke
- Medical subject headings
- Motor Activity, Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Box and Block TestDiagnostic test
Also called questionnaire
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Diagnostic Test: Box and Block Test |
What is being measured
The primary outcome is the main question the study is designed to answer.
results from the Box and Block Test
number of transported blocks
Measured: 30 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2021
- Study start31 May 2021
- Primary completion28 Feb 2022
- Study completion30 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
- 20 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
- NCT05009121
- Sponsor's protocol ID
- 75/21 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 Box and Block Test in People After Stroke
- ClinicalTrials.gov ID
- NCT05009121
- Acronym / sponsor ID
- 75/21 S-IV
- Conditions
- Motor Activity
- Keywords
- standardized test, occupational therapy, fine motor skills, Box and Block Test, inter-rater reliability, variability, Czech language, Stroke
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Charles University, Czech RepublicUniversity, hospital or other
- Study start
- 31 May 2021 (actual)
- Primary completion
- 28 Feb 2022 (actual)
- Study completion
- 30 Dec 2024 (estimated)
- First posted
- 17 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 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.
Detailed description
New Czech manual for the Box and Block Test was made by back-translation method. It was updated and extended by new rules for unification of it´s performing. The manual include instructions for performing three trials.
At least 20 adult people after stroke will be tested by this test according to this new Czech manual. Video of patients' performance will be obtained.
The inter-rater reliability, internal variability and variability of results will be established.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Czech adult people after stroke | – | Diagnostic Test: Box and Block TestCzech 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Czech adult people after stroke
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (6 listed)
- use of drugs affecting attention
- vision impairment uncorrectable with glasses
- severe hearing loss
- inability to understand instructions
- inability to 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 |
|---|---|---|
| Box and Block TestAlso: questionnaireAt 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. | Diagnostic test | Czech adult people after stroke |
Primary outcome
results from the Box and Block Test
Time frame: 30 minutes
number of transported blocks
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.
1 site 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 1 site 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 6 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 1 site 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 Box and Block Test (time frame: 30 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.