Developmental Coordination DisorderNCT03285776
Reliability and Validity of a Computerized Tool to Assess Proprioception Among Children With Coordination Disorders
An observational study of Developmental Coordination Disorder and Developmental Dyspraxia, run by Jay Zuckerman at 1 site in Israel.
Trial summary
Coordination disorders are common among children that arrive to child development services. Children with coordination disorders have impaired proprioceptive sensation and motor planning. Read more about this study
- Who is it for?
- Ages 5 to 7 yearsHealthy volunteers can take part
- Conditions the study is for
- Developmental Coordination Disorder, Developmental Dyspraxia, Clumsy Child Syndrome
- How many people
- 52 participants
- Where
- 1 siteIsrael
- Study dates
- 5 Dec 2017to 1 Jun 2019
- 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 5 to 7 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: The participants will include fifty children between the ages of 5 to 7 years: the study group - 25 children in a waiting list for an occupational therapy evaluation (in Orlansky Children's Development Center, Dan -Petah Tikva Region, Clalit Health Services), the control group - 25 children with typical development.
Who may be able to join
- Children aged 5-7, insured by "Clalit Health Services", and their parents. Inclusion into groups will be done according to the DCDQ'07 Developmental Questionnaire (DCDQ'07).
- Inclusion to study group: children in a waiting list for an occupational therapy evaluation due to difficulties in fine or gross motor difficulties in performing daily activities as self-treatment, Play and recreation, and suspicion of developmental delay and DCD. children are able to communicate and understand instructions in Hebrew, and their parents know the Hebrew language at the level of reading and writing. A score of 15-46 indicating DCD or suspected DCD in the DCDQ'07 questionnaire.
- Inclusion into control group: healthy children with a typical development who are able to communicate and understand Hebrew instructions, and whose parents know the Hebrew language at the level of reading and writing. A score of 47-75 indicates that there is no DCD in the DCDQ'07 questionnaire.
Who cannot join
- Children with developmental syndromes such as autism, cerebral palsy, orthopedic or neurological diseases, including sensory systems, such as impaired vision, will not be included in the study (according to parents' questioning, if no information will be available in the medical record). Children who study in special education frames (according to parental questioning) will not be included in the study. Children who have previously been treated in occupational therapy will not included.
Trial locations and contacts
1 site in 1 country.
About this study
Coordination disorders are common among children that arrive to child development services. Children with coordination disorders have impaired proprioceptive sensation and motor planning. It is important to carry out a comprehensive assessment of these children in order to design an appropriate and effective treatment. There is a lack of an objective and standard assessment tools for proprioception and motor planning. Technology based assessment tools might offer a solution, as they enable automated and accurate measurement. The purpose of this study is to examine the validity and reliability of a new diagnostic computerized kit, which was developed for assessment of proprioception and motor planning among children with coordination disorders. The hypothesis includes:
- Examine the construct validity of the new diagnostic computerized kit (the known group procedure). Whether there is a difference in the outcomes between children with typical development and children with coordination disorders.
- Examine the construct validity of the new diagnostic computerized kit outcomes - correlation with the following associated variables: (a) motor skills; (b) sensory function; (c) participation in daily activities.
- Examine of test-retest reliability of the new diagnostic computerized kit. Whether the outcomes are stable in repeated measurements.
Read more
The participants will include fifty children between the ages of 5 to 7 years: 25 children with coordination disorders (study group), and 25 children with typical development (control group).
Each child will arrive for an evaluation meeting that includes: (a) the new diagnostic computerized kit; (b) standard and routine tests for motor skills (Movement Assessment Battery for Children-2-MABC-2, and two sub-test of the Beery-Buktenica developmental test of visual-motor integration- Beery VMI). In addition, the children's parents will complete two questionnaires: (a) Sensory Processing Measurement (SPM) for sensory function assessment; (b) Participation in Childhood Occupations Questionnaire (PICO-Q) for daily participation assessment. After two weeks, ten children from the control group will be evaluated once again by the new diagnostic computerized kit for examine test-retest reliability.
Read the detailed description
Coordination disorders are common among children that arrive to child development services. Children with coordination disorders have impaired proprioceptive sensation and motor planning. It is important to carry out a comprehensive assessment of these children in order to design an appropriate and effective treatment. There is a lack of an objective and standard assessment tools for proprioception and motor planning. Technology based assessment tools might offer a solution, as they enable automated and accurate measurement. The purpose of this study is to examine the validity and reliability of a new diagnostic computerized kit, which was developed for assessment of proprioception and motor planning among children with coordination disorders.
The new diagnostic computerized kit consists a computerized thumb- fingers matching test (for proprioception).
The hypothesis includes:
- Examine the construct validity of the new diagnostic computerized kit (the known group procedure). Whether there is a difference in the outcomes between children with typical development and children with coordination disorders.
- Examine the construct validity of the new diagnostic computerized kit outcomes - correlation with the following associated variables: (a) motor skills; (b) sensory function; (c) participation in daily activities.
- Examine of test-retest reliability of the new diagnostic computerized kit. Whether the outcomes are stable in repeated measurements.
The participants will include fifty children between the ages of 5 to 7 years: 25 children with coordination disorders (study group) in a waiting list for an occupational therapy evaluation (in Orlansky Children's Development Center, Dan -Petah Tikva Region, Clalit Health Services), and 25 children with typical development (control group).
The participants will be recruited by a convenience sample. Participation in the study will be offered by telephone to parents of children who may meet the inclusion /exclusion criteria. For the study group the recruitment will be to children in a waiting list for an occupational therapy evaluation (in Orlansky Children's Development Center). For the control group, the recruitment will be by a snowball sample (a friend brings a friend), through acquaintances of the investigators. Children whose parents agree to participate in the study will attend one meeting, accompanied by at least one parent. At the beginning of the meeting, the parents will receive a detailed explanation about the purpose and the study process. The new diagnostic computerized kit will be presented and explained how to use it. Parents will be assured total privacy. In addition, parents of children from the study group will be told that their child's medical record will be used to ensure inclusion and exclusion criteria. Parents who express their consent to participate in the study will sign an informed consent form and then complete a demographic questionnaire and a screening questionnaire. Children that will be find suitable for the study will Be evaluated by: (a) the new diagnostic computerized kit; (b) standard and routine tests for motor skills (Movement Assessment Battery for Children-2-MABC-2, and two sub-test of the Beery-Buktenica developmental test of visual-motor integration- Beery VMI). In addition, the children's parents will complete two questionnaires: (a) Sensory Processing Measurement (SPM) for sensory function assessment; (b) Participation in Childhood Occupations Questionnaire (PICO-Q) for daily participation assessment. After two weeks, ten children from the control group will be evaluated once again by the new diagnostic computerized kit for examine test-retest reliability.
Analysis of the data will be done using the SPSS version 32. Descriptive statistics will be used for description of the population and the variables. Shapiro-wilks test will be used to examine the type of distribution of the dependent variables. According to the type of distribution will use t-test for two independent samples or Mann-Whitney test to examine the differences between groups (hypothesis 1). Pearson Correlation Coefficient test or Spearman's Rank Correlation Coefficient test will be used to examine correlation between the outcomes of the assessment tools (hypothesis 2 and 3). The significance level for all the statistical tests will be p<0.05.
- Medical subject headings
- Motor Skills Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Study group | Children with coordination disorder between the ages of 5 to 7 years. | |
| control group | children with typical development between the ages of 5 to 7 years. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total time- outcome of the new diagnostic computerized kit - computerized thumb fingers matching test.
Time is one of the outcome measures of the computerized thumb fingers matching test, that is measured in a ratio scale.
Measured: Time duration for this test is 5 minutes.
Standard Deviation (SD) of touch time- outcome of the new diagnostic computerized kit - computerized thumb fingers matching test.
Standard Deviation (SD) of touch time is one of the outcome measures of the computerized thumb fingers matching test, that is measured in a ratio scale by sensors of the touches.
Measured: Time duration for this test is 5 minutes.
Correct sequence- outcome of the new diagnostic computerized kit - computerized thumb fingers matching test.
Correct sequence is one of the outcome measures of the computerized thumb fingers matching test, that is measured in a ratio scale by sensors of the touches.
Measured: Time duration for this test is 5 minutes.
Secondary outcomes (13)
Visual-motor integration outcome of the Beery-Buktenica developmental test of visual-motor integration (Beery VMI).
Visual-motor integration grade is measured in a ratio scale from the Beery VMI test.
Measured: Time duration for this test is 10 minutes. only one time point
Motor coordination outcome of the Beery-Buktenica developmental test of visual-motor integration (Beery VMI).
Motor coordination grade is measured in a ratio scale from the Beery VMI test.
Measured: Time duration for this test is 5 minutes. only one time point
Physical awareness outcome of the Sensory Processing Measurement (SPM).
Questionaire for the parents that is measured in a Likert scale.
Measured: Time duration for this questionaire is 20 minutes. only one time point
Balance and movement outcome of the Sensory Processing Measurement (SPM) .
Questionaire for the parents that is measured in a Likert scale.
Measured: Time duration for this questionaire is 20 minutes. only one time point
Planning and ideation outcome of the Sensory Processing Measurement (SPM).
Questionaire for the parents that is measured in a Likert scale.
Measured: Time duration for this questionaire is 20 minutes. only one time point
Total sensory systems outcome of the Sensory Processing Measurement (SPM).
Questionaire for the parents that is measured in a Likert scale.
Measured: Time duration for this questionaire is 20 minutes. only one time point
Difficulty in performance outcome of the Participation in Childhood Occupations Questionaire (PICO-Q).
Questionaire for the parents that is measured in a Likert scale.
Measured: Time duration for this questionaire is 15 minutes. only one time point
Frequency of performance outcome of the Participation in Childhood Occupations Questionaire (PICO-Q).
Questionaire for the parents that is measured in a Likert scale.
Measured: Time duration for this questionaire is 15 minutes. only one time point
Enjoyment outcome of the Participation in Childhood Occupations Questionaire (PICO-Q).
Questionaire for the parents that is measured in a Likert scale.
Measured: Time duration for this questionaire is 15 minutes. only one time point
Movement Assessment Battery for Children-2 (MABC-2)- general grade.
General grade of the subject's motor performance, that is measured in a ratio scale from the MABC-2.
Measured: Time duration for this test is 30 minutes. only one time point
Balance outcome of the Movement Assessment Battery for Children-2 (MABC-2).
Balance grade is measured in a ratio scale from the MABC-2.
Measured: Time duration for this test is 10 minutes. only one time point
Ball skills outcome of the Movement Assessment Battery for Children-2 (MABC-2).
Ball skills grade is measured in a ratio scale from the MABC-2.
Measured: Time duration for this test is 10 minutes. only one time point
Fine manual skills outcome of the Movement Assessment Battery for Children-2 (MABC-2).
Fine manual skills grade is measured in a ratio scale from the MABC-2.
Measured: Time duration for this test is 10 minutes. only one time point
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2017
- Study start5 Dec 2017
- Primary completion1 Jan 2019
- Study completion1 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Developmental Coordination DisorderStudies 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
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jay Zuckerman
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Jay Zuckerman, Meir Medical Center
- Investigators
- jay zuckerman, DR, Principal investigator, Israel: Clalit Health Services
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03285776
- Sponsor's protocol ID
- MMC170038-17kCTIL
- Status last verified
- Mar 2020
- First submitted
- 10 Sep 2017
- Last updated
- 2 Apr 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reliability and Validity of a Computerized Tool to Assess Proprioception Among Children With Coordination Disorders
- ClinicalTrials.gov ID
- NCT03285776
- Acronym / sponsor ID
- MMC170038-17kCTIL
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Jay ZuckermanUniversity, hospital or other
- Study start
- 5 Dec 2017 (actual)
- Primary completion
- 1 Jan 2019 (actual)
- Study completion
- 1 Jun 2019 (actual)
- First posted
- 18 Sep 2017 (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.
Coordination disorders are common among children that arrive to child development services. Children with coordination disorders have impaired proprioceptive sensation and motor planning. It is important to carry out a comprehensive assessment of these children in order to design an appropriate and effective treatment. There is a lack of an objective and standard assessment tools for proprioception and motor planning. Technology based assessment tools might offer a solution, as they enable automated and accurate measurement. The purpose of this study is to examine the validity and reliability of a new diagnostic computerized kit, which was developed for assessment of proprioception and motor planning among children with coordination disorders. The hypothesis includes:
- Examine the construct validity of the new diagnostic computerized kit (the known group procedure). Whether there is a difference in the outcomes between children with typical development and children with coordination disorders.
- Examine the construct validity of the new diagnostic computerized kit outcomes - correlation with the following associated variables: (a) motor skills; (b) sensory function; (c) participation in daily activities.
- Examine of test-retest reliability of the new diagnostic computerized kit. Whether the outcomes are stable in repeated measurements.
The participants will include fifty children between the ages of 5 to 7 years: 25 children with coordination disorders (study group), and 25 children with typical development (control group).
Each child will arrive for an evaluation meeting that includes: (a) the new diagnostic computerized kit; (b) standard and routine tests for motor skills (Movement Assessment Battery for Children-2-MABC-2, and two sub-test of the Beery-Buktenica developmental test of visual-motor integration- Beery VMI). In addition, the children's parents will complete two questionnaires: (a) Sensory Processing Measurement (SPM) for sensory function assessment; (b) Participation in Childhood Occupations Questionnaire (PICO-Q) for daily participation assessment. After two weeks, ten children from the control group will be evaluated once again by the new diagnostic computerized kit for examine test-retest reliability.
Detailed description
Coordination disorders are common among children that arrive to child development services. Children with coordination disorders have impaired proprioceptive sensation and motor planning. It is important to carry out a comprehensive assessment of these children in order to design an appropriate and effective treatment. There is a lack of an objective and standard assessment tools for proprioception and motor planning. Technology based assessment tools might offer a solution, as they enable automated and accurate measurement. The purpose of this study is to examine the validity and reliability of a new diagnostic computerized kit, which was developed for assessment of proprioception and motor planning among children with coordination disorders.
The new diagnostic computerized kit consists a computerized thumb- fingers matching test (for proprioception).
The hypothesis includes:
- Examine the construct validity of the new diagnostic computerized kit (the known group procedure). Whether there is a difference in the outcomes between children with typical development and children with coordination disorders.
- Examine the construct validity of the new diagnostic computerized kit outcomes - correlation with the following associated variables: (a) motor skills; (b) sensory function; (c) participation in daily activities.
- Examine of test-retest reliability of the new diagnostic computerized kit. Whether the outcomes are stable in repeated measurements.
The participants will include fifty children between the ages of 5 to 7 years: 25 children with coordination disorders (study group) in a waiting list for an occupational therapy evaluation (in Orlansky Children's Development Center, Dan -Petah Tikva Region, Clalit Health Services), and 25 children with typical development (control group).
The participants will be recruited by a convenience sample. Participation in the study will be offered by telephone to parents of children who may meet the inclusion /exclusion criteria. For the study group the recruitment will be to children in a waiting list for an occupational therapy evaluation (in Orlansky Children's Development Center). For the control group, the recruitment will be by a snowball sample (a friend brings a friend), through acquaintances of the investigators. Children whose parents agree to participate in the study will attend one meeting, accompanied by at least one parent. At the beginning of the meeting, the parents will receive a detailed explanation about the purpose and the study process. The new diagnostic computerized kit will be presented and explained how to use it. Parents will be assured total privacy. In addition, parents of children from the study group will be told that their child's medical record will be used to ensure inclusion and exclusion criteria. Parents who express their consent to participate in the study will sign an informed consent form and then complete a demographic questionnaire and a screening questionnaire. Children that will be find suitable for the study will Be evaluated by: (a) the new diagnostic computerized kit; (b) standard and routine tests for motor skills (Movement Assessment Battery for Children-2-MABC-2, and two sub-test of the Beery-Buktenica developmental test of visual-motor integration- Beery VMI). In addition, the children's parents will complete two questionnaires: (a) Sensory Processing Measurement (SPM) for sensory function assessment; (b) Participation in Childhood Occupations Questionnaire (PICO-Q) for daily participation assessment. After two weeks, ten children from the control group will be evaluated once again by the new diagnostic computerized kit for examine test-retest reliability.
Analysis of the data will be done using the SPSS version 32. Descriptive statistics will be used for description of the population and the variables. Shapiro-wilks test will be used to examine the type of distribution of the dependent variables. According to the type of distribution will use t-test for two independent samples or Mann-Whitney test to examine the differences between groups (hypothesis 1). Pearson Correlation Coefficient test or Spearman's Rank Correlation Coefficient test will be used to examine correlation between the outcomes of the assessment tools (hypothesis 2 and 3). The significance level for all the statistical tests will be p<0.05.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Study group | – | –Children with coordination disorder between the ages of 5 to 7 years. |
| control group | – | –children with typical development between the ages of 5 to 7 years. |
Who may qualify
- Ages
- 5 to 7 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- The participants will include fifty children between the ages of 5 to 7 years: the study group - 25 children in a waiting list for an occupational therapy evaluation (in Orlansky Children's Development Center, Dan -Petah Tikva Region, Clalit Health Services), the control group - 25 children with typical development.
Key inclusion criteria (3 listed)
- Children aged 5-7, insured by "Clalit Health Services", and their parents. Inclusion into groups will be done according to the DCDQ'07 Developmental Questionnaire (DCDQ'07).
- Inclusion to study group: children in a waiting list for an occupational therapy evaluation due to difficulties in fine or gross motor difficulties in performing daily activities as self-treatment, Play and recreation, and suspicion of developmental delay and DCD. children are able to communicate and understand instructions in Hebrew, and their parents know the Hebrew language at the level of reading and writing. A score of 15-46 indicating DCD or suspected DCD in the DCDQ'07 questionnaire.
- Inclusion into control group: healthy children with a typical development who are able to communicate and understand Hebrew instructions, and whose parents know the Hebrew language at the level of reading and writing. A score of 47-75 indicates that there is no DCD in the DCDQ'07 questionnaire.
Key exclusion criteria (1 listed)
- Children with developmental syndromes such as autism, cerebral palsy, orthopedic or neurological diseases, including sensory systems, such as impaired vision, will not be included in the study (according to parents' questioning, if no information will be available in the medical record). Children who study in special education frames (according to parental questioning) will not be included in the study. Children who have previously been treated in occupational therapy will not included.
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
Total time- outcome of the new diagnostic computerized kit - computerized thumb fingers matching test.
Time frame: Time duration for this test is 5 minutes.
Time is one of the outcome measures of the computerized thumb fingers matching test, that is measured in a ratio scale.
Standard Deviation (SD) of touch time- outcome of the new diagnostic computerized kit - computerized thumb fingers matching test.
Time frame: Time duration for this test is 5 minutes.
Standard Deviation (SD) of touch time is one of the outcome measures of the computerized thumb fingers matching test, that is measured in a ratio scale by sensors of the touches.
Correct sequence- outcome of the new diagnostic computerized kit - computerized thumb fingers matching test.
Time frame: Time duration for this test is 5 minutes.
Correct sequence is one of the outcome measures of the computerized thumb fingers matching test, that is measured in a ratio scale by sensors of the touches.
13 secondary outcomes
Visual-motor integration outcome of the Beery-Buktenica developmental test of visual-motor integration (Beery VMI).
Time frame: Time duration for this test is 10 minutes. only one time point
Motor coordination outcome of the Beery-Buktenica developmental test of visual-motor integration (Beery VMI).
Time frame: Time duration for this test is 5 minutes. only one time point
Physical awareness outcome of the Sensory Processing Measurement (SPM).
Time frame: Time duration for this questionaire is 20 minutes. only one time point
Balance and movement outcome of the Sensory Processing Measurement (SPM) .
Time frame: Time duration for this questionaire is 20 minutes. only one time point
Planning and ideation outcome of the Sensory Processing Measurement (SPM).
Time frame: Time duration for this questionaire is 20 minutes. only one time point
Total sensory systems outcome of the Sensory Processing Measurement (SPM).
Time frame: Time duration for this questionaire is 20 minutes. only one time point
Difficulty in performance outcome of the Participation in Childhood Occupations Questionaire (PICO-Q).
Time frame: Time duration for this questionaire is 15 minutes. only one time point
Frequency of performance outcome of the Participation in Childhood Occupations Questionaire (PICO-Q).
Time frame: Time duration for this questionaire is 15 minutes. only one time point
Enjoyment outcome of the Participation in Childhood Occupations Questionaire (PICO-Q).
Time frame: Time duration for this questionaire is 15 minutes. only one time point
Movement Assessment Battery for Children-2 (MABC-2)- general grade.
Time frame: Time duration for this test is 30 minutes. only one time point
Balance outcome of the Movement Assessment Battery for Children-2 (MABC-2).
Time frame: Time duration for this test is 10 minutes. only one time point
Ball skills outcome of the Movement Assessment Battery for Children-2 (MABC-2).
Time frame: Time duration for this test is 10 minutes. only one time point
Fine manual skills outcome of the Movement Assessment Battery for Children-2 (MABC-2).
Time frame: Time duration for this test is 10 minutes. only one time point
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 2 Apr 2020.
- Individual participant dataSharing planned: Undecided
Related trials for Developmental Coordination Disorder
RecruitingObservational study
Rare Disease Patient Registry & Natural History Study - Coordination of Rare Diseases at Sanford
Rare Disorders, Undiagnosed Disorders
Enrolling by invitation
BEhavioral Health Stratified Treatment (BEST) Study for Youth With Intellectual and/or Developmental Disabilities (IDD)
Depression, Anxiety
Not yet recruiting
Video-Assisted Core Stabilization Exercises in Children With Developmental Coordination Disorder
Developmental Coordination Disorder (DCD)
Not yet recruitingObservational study
Wearable Sensor Toolkit for Infant Motor Development
Motor Delay, Infant Development
Not yet recruiting
Neuromotor Task Training in Autistic Children With Motor Difficulties
Autism Spectrum Disorder (ASD)
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.
jay zuckerman, DR principal investigator
Israel: Clalit Health Services
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 Developmental Coordination Disorder and Developmental Dyspraxia, run by Jay Zuckerman at 1 site in Israel.
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 3 inclusion and 1 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 2 Apr 2020. 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 Israel. 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?
Total time- outcome of the new diagnostic computerized kit - computerized thumb fingers matching test. (time frame: Time duration for this test is 5 minutes.). The study lists 3 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 2 Apr 2020.