StrokeNCT05215795
Validity and Reliability of Modified Box and Block Test and Targeted Box and Block Test in Patients With Stroke
An observational study of Stroke, run by Kutahya Health Sciences University at 1 site in Turkey (Türkiye).
Trial summary
The aim of our study is investigated validity and reliabilty of Modified Box and Block Test and Targeted Box and Block Test in patients with stroke. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Stroke
- How many people
- 50 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Sep 2021to 1 Oct 2022
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients with stroke
Who may be able to join
- Diagnosed with stroke and in the chronic phase (having been diagnosed with stroke at least 6 months ago),
- Over 18 years old,
- Mini Mental Test score ≥ 24 points,
- Able to grasp and release a 2.5 cm cube on both upper extremities,
- Brunnstrom Upper Extremity Staging ≥ 3
- Modified Ashworth Scale ≤ 2,
- Able to sit independently in a chair for 2 minutes
Who cannot join
- Having a neurological disease other than stroke
- Have had surgery in the last 6 months
- Severely affected upper extremity
- Uncooperative with physiotherapist
- Patients with neglect, aphasia and hemianopsia
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Kutahya Health Sciences University
Kütahya, 43100
About this study
The aim of our study is investigated validity and reliabilty of Modified Box and Block Test and Targeted Box and Block Test in patients with stroke.
Read the detailed description
Fifty patients with stroke will included in the study. Box and Block Test, Modified Box and Block Test, Targeted Box and Block Test, 9 Hole Peg Test, Fugl-Meyer Assessment of the upper extremity will used to assess upper extremity. To evaluate validity between Modified and Targeted Box and Block Tests and Box and Block Test, 9 Hole Peg Test, Fugl-Meyer Assessment will used to correlation analysis tests. The investigator will evaluate after one week to test-retest reliability to patients. Other pyhsiotherapist will evaluate to patients inter-rater reliability.
- Conditions
- Stroke
- Keywords
- Validity, Reliability, Modified Box and Block Test, Targeted Box and Block Test, Upper Extremity
- Medical subject headings
- Stroke
What is being measured
The primary outcome is the main question the study is designed to answer.
Modified Box and Block Test
The Modified Box and Block (mBBT) test is an upper extremity performance test.Unlike BBT, in mBBT, instead of randomly picking the cubes, 16 cubes are arranged in a certain order.
The cubes are asked to take the other cubes in that row, starting from the innermost left cube, first to the right, and then to the next upper row.
It is recorded how many seconds passed through 16 cubes placed at a certain level.
Measured: 10 minute
Targeted Box and Block Test
In tBBT, as in mBBT, the time of passing 16 cubes over the obstacle to the other side is recorded. However, the difference from mKBT is that 16 cubes are placed at a certain level, but the patients are asked to place the cubes on the other side in 4 cm squares where the cube will be placed.
These squares correspond to the left symmetrical position of the cube on the right.
In this way, patients have to place the cube they grasp only at the desired point.
Measured: 10 minute
Secondary outcomes (3)
9 Hole Peg Test
9HPT is a dexterity test.The patient is asked to place the 9 wooden blocks into the 9 holes in the maximum amount of time.Then he is asked to take it out and put it back in its place. The total time is recorded.
Measured: 10 minute
Fugl-Meyer Assessment for Upper Extremity
The Fugl-Meyer Assessment is a disease-specific impairment index designed to assess motor function, balance, sensation qualities and joint function in hemiplegic post-stroke patients.The scale consists of four categories (Shoulder/Elbow/Forearm, Wrist, Hand/Finger, and Coordination) and evaluates 23 different movements in 33 sections.The maximum score is 66 points
Measured: 15 minutes
Box and Block Test
Box and Block (mBBT) test is an upper extremity performance test. The patient is instructed to move as many blocks as possible, one at a time, from one compartment to the other for a period of 60 seconds. The number of cubes passed to the other side in 60 seconds is recorded.
Measured: 5 minute
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2022
- Study start1 Sep 2021
- Primary completion1 Oct 2022
- Study completion1 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- 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
- Other
- Time perspective
- Prospective
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kutahya Health Sciences University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lütfiye AKKURT, MSc, Kutahya Health Sciences University
- Investigators
- Lütfiye AKKURT, MSc, Principal investigator, Kutahya Health Sciences UniversityCihan Caner AKSOY, PhD, Study director, Kutahya Health Sciences UniversityFatıma YAMAN, MD, Principal investigator, Kutahya Health Sciences University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05215795
- Sponsor's protocol ID
- KutahyaHSU3
- Status last verified
- Jan 2023
- First submitted
- 19 Jan 2022
- Last updated
- 13 Jan 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validity and Reliability of Modified Box and Block Test and Targeted Box and Block Test in Patients With Stroke
- ClinicalTrials.gov ID
- NCT05215795
- Acronym / sponsor ID
- KutahyaHSU3
- Conditions
- Stroke
- Keywords
- Validity, Reliability, Modified Box and Block Test, Targeted Box and Block Test, Upper Extremity
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Kutahya Health Sciences UniversityUniversity, hospital or other
- Study start
- 1 Sep 2021 (actual)
- Primary completion
- 1 Oct 2022 (actual)
- Study completion
- 1 Oct 2022 (actual)
- First posted
- 31 Jan 2022 (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 aim of our study is investigated validity and reliabilty of Modified Box and Block Test and Targeted Box and Block Test in patients with stroke.
Detailed description
Fifty patients with stroke will included in the study. Box and Block Test, Modified Box and Block Test, Targeted Box and Block Test, 9 Hole Peg Test, Fugl-Meyer Assessment of the upper extremity will used to assess upper extremity. To evaluate validity between Modified and Targeted Box and Block Tests and Box and Block Test, 9 Hole Peg Test, Fugl-Meyer Assessment will used to correlation analysis tests. The investigator will evaluate after one week to test-retest reliability to patients. Other pyhsiotherapist will evaluate to patients inter-rater reliability.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with stroke
Key inclusion criteria (7 listed)
- Diagnosed with stroke and in the chronic phase (having been diagnosed with stroke at least 6 months ago),
- Over 18 years old,
- Mini Mental Test score ≥ 24 points,
- Able to grasp and release a 2.5 cm cube on both upper extremities,
- Brunnstrom Upper Extremity Staging ≥ 3
Key exclusion criteria (5 listed)
- Having a neurological disease other than stroke
- Have had surgery in the last 6 months
- Severely affected upper extremity
- Uncooperative with physiotherapist
- Patients with neglect, aphasia and hemianopsia
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Modified Box and Block Test
Time frame: 10 minute
The Modified Box and Block (mBBT) test is an upper extremity performance test.Unlike BBT, in mBBT, instead of randomly picking the cubes, 16 cubes are arranged in a certain order. The cubes are asked to take the other cubes in that row, starting from the innermost left cube, first to the right, and then to the next upper row. It is recorded how many seconds passed through 16 cubes placed at a certain level.
Targeted Box and Block Test
Time frame: 10 minute
In tBBT, as in mBBT, the time of passing 16 cubes over the obstacle to the other side is recorded. However, the difference from mKBT is that 16 cubes are placed at a certain level, but the patients are asked to place the cubes on the other side in 4 cm squares where the cube will be placed. These squares correspond to the left symmetrical position of the cube on the right. In this way, patients have to place the cube they grasp only at the desired point.
3 secondary outcomes
9 Hole Peg Test
Time frame: 10 minute
Fugl-Meyer Assessment for Upper Extremity
Time frame: 15 minutes
Box and Block Test
Time frame: 5 minute
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2023.
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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.
Lütfiye AKKURT, MSc principal investigator
Kutahya Health Sciences University
Cihan Caner AKSOY, PhD study director
Kutahya Health Sciences University
Fatıma YAMAN, MD principal investigator
Kutahya Health Sciences University
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 Stroke, run by Kutahya Health Sciences University at 1 site in Turkey (Türkiye).
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 7 inclusion and 5 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: finished, as of the sponsor's last update on 13 Jan 2023. 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 Turkey (Türkiye). 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Modified Box and Block Test (time frame: 10 minute). The study lists 2 primary outcomes in all. 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 13 Jan 2023.