ReadingPLAYMORENCT04618822
Play-based Motor-Cognitive Training for Improved Reading
A study testing Teaching involving whole-body movements and Teaching involving hand movements in people with Reading, run by University of Copenhagen at 1 site in Denmark.
Trial summary
The PLAYMORE study aims to investigate the effects of two interventions focusing on a close and meaningful coupling between bodily movement and academic content on early pre-reading and word recognition skills in children. Further, the study aims to compare two interventions involving either hand movements (i.e. Read more about this study
- Who is it for?
- Ages 5 to 7 yearsHealthy volunteers can take part
- Conditions the study is for
- Reading
- What is being tested?
- Teaching involving whole-body movements and Teaching involving hand movements
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 149 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Sep 2020to 14 Apr 2021
- Phase
- Interventional
- 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
Who may be able to join
- Children five to six years old who have just started school
Who cannot join
- Children who do not speak any Danish
- Children with cognitive or physical disabilities hindering participation in the project activities
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Motor-enriched Learning for Improving Pre-reading and Word Recognition Skills in Preschool Children Aged 5-6 Years
The PLAYMORE study aims to investigate the effects of two interventions focusing on a close and meaningful coupling between bodily movement and academic content on early pre-reading and word recognition skills in children. Further, the study aims to compare two interventions involving either hand movements (i.e. using arms and hands) or whole-body movements (i.e. using the whole body). Potential mediating factors underlying the potential effect of bodily movement on early pre-reading and word recognition skills will be explored. The PLAYMORE study will be conducted as a three-armed randomized controlled trial including children aged five to six years recruited from four schools in the Copenhagen area, Denmark. Stratified by class, children will be randomly allocated to one of three 8-week intervention/control periods: 1) teaching involving whole-body movements, 2) teaching involving hand movements (i.e. arms and hands) or 3) teaching involving minimal motor movements (i.e. seated on a chair using paper and pencil). Outcome measurements, including pre-reading and word recognition skills, will be collected before and after the intervention period to assess the intervention effects. This study protocol follows the SPIRIT guidelines.
- Conditions
- Reading
- Being tested
- Teaching involving whole-body movements, Teaching involving hand movements, Teaching involving minimal motor movements (control)
- Keywords
- motor-enriched learning, embodied learning, physically active lessons, pre-reading skills, word recognition, preschool children
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Teaching involving whole-body movementsBehavioural
The intervention consist of three 30 minutes sessions per week for eight weeks. Activities are conducted in small groups of six children and focus on the acquisition of letterforms, letter-sound correspondences and reading and spelling of short words. Activities involve whole-body movements and have been developed with the embodied learning theory in mind, linking movement closely to the learning content.
Teaching involving hand movementsBehavioural
The intervention consist of three 30 minutes sessions per week for eight weeks. Activities are conducted in small groups of six children and focus on the acquisition of letterforms, letter-sound correspondences and reading and spelling of short words. Activities involve movements using hands and arms and have been developed with the embodied learning theory in mind, linking movement closely to the learning content.
Teaching involving minimal motor movements (control)Behavioural
The control condition consist of three 30 minutes sessions per week for eight weeks. Activities are conducted in groups of app. twelve children and focus on the acquisition of letterforms, letter-sound correspondences and reading and spelling of short words. Activities are completed seated on a chair using paper and pencil.
| Study group | Role | What they receive |
|---|---|---|
| Teaching involving whole-body movements | Experimental | Not described Receives: Behavioral: Teaching involving whole-body movements |
| Teaching involving hand movements | Experimental | i.e. arms and hands Receives: Behavioral: Teaching involving hand movements |
| teaching involving minimal motor movements | Active comparator | i.e. seated on a chair using paper and pencil Receives: Behavioral: Teaching involving minimal motor movements (control) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in word reading speed and accuracy (reading of 18 trained words) at 8 weeks, computer-based test
This word reading test consist of 18 presentations of targets words; one target word per presentation. Below the target word are placed four pictures of which one illustrates the target word. For the children to give a correct answer, they will have to touch the picture matching the target word on the touch screen. They are asked to touch the correct picture as fast as possible. The three remaining pictures represents words (distractors) that have either the initial (two pictures) or the final (one picture) sound in common with the target word. The presentations of target words and the order of the four pictures are randomized between subjects and time points. During the test, children are allowed to ask questions concerning the pictures (e.g. what is shown on this picture?) but not regarding the target word (e.g. what is the sound of this letter?). The results from the test constitute mean response time for correct answers and number of correct answers.
Measured: Baseline and 8-weeks
Change from baseline in trained letter-sound correspondences accuracy (15 trials) at 8 weeks, paper and pencil test
The test consists of 15 trials. In each trial, a sound corresponding to a standard or a conditional pronunciation of a letter is said out loud by the assessor. Children are instructed to identify the correct letter matching the sound from a row of four letters. Before the test trials, children will be provided with one practice trial. The 15 sounds represent both standard and conditional pronunciations of the letters a, e, o, r, u and v. Results are numbers of correct letter-sound correspondences.
Measured: Baseline and 8-weeks
Secondary outcomes (12)
Change from baseline in word reading accuracy (reading of 12 untrained words) at 8 weeks, computer-based test
This test consists of 12 presentations of untrained words; one word per presentation. The 12 words consist of four 2-letter words, four 3-letter words and four 4-letter words.
Measured: Baseline and 8-weeks
Change from baseline in letter naming fluency accuracy at 8 weeks
This Danish version of the Letter Naming test is based on the same principles as DIBELS Letter Naming Fluency (Good \& Kaminski, 2002). The test consists of a piece of paper (A4) with 12 rows of 10 letters (mixed upper- and lower case).
Measured: Baseline and 8-weeks
Change from baseline in letter-sound correspondence accuracy, Bogstaveprøve 2 ['Letter test 2'] at 8 weeks
This test has been widely used in the Danish school system. The test consists of two subtests assessing simple letter-sound knowledge and vowel identification, respectively. For the purpose of the present study, only the first subtest will be administered to assess standard letter-sound knowledge.
Measured: Baseline and 8-weeks
Change from baseline in word reading accuracy and speed, Ordlæseprøve 1 ['Word reading test 1'] at 8 weeks
This test is widely used in the Danish school system. The test consists of 78 items (preceded by two practice items) and evaluates word reading accuracy as well as efficiency.
Measured: Baseline and 8-weeks
Change from baseline in word reading speed and accuracy (reading of 18 trained words) at 18 weeks, computer-based test
This word reading test consist of 18 presentations of targets words; one target word per presentation. Below the target word are placed four pictures of which one illustrates the target word. For the children to give a correct answer, they will have to touch the picture matching the target word on the touch screen. They are asked to touch the correct picture as fast as possible. The three remaining pictures represents words (distractors) that have either the initial (two pictures) or the final (one picture) sound in common with the target word. The presentations of target words and the order of the four pictures are randomized between subjects and time points. During the test, children are allowed to ask questions concerning the pictures (e.g. what is shown on this picture?) but not regarding the target word (e.g. what is the sound of this letter?). The results from the test constitute mean response time for correct answers and number of correct answers.
Measured: Baseline and 18-weeks
Change from baseline in trained letter-sound correspondences accuracy (15 trials) at 18 weeks, paper and pencil test
The test consists of 15 trials. In each trial, a sound corresponding to a standard or a conditional pronunciation of a letter is said out loud by the assessor. Children are instructed to identify the correct letter matching the sound from a row of four letters. Before the test trials, children will be provided with one practice trial. The 15 sounds represent both standard and conditional pronunciations of the letters a, e, o, r, u and v. Results are numbers of correct letter-sound correspondences.
Measured: Baseline and 18-weeks
Change in word reading speed and accuracy (reading of 18 trained words) between 8 weeks and 18 weeks, computer-based test
This word reading test consist of 18 presentations of targets words; one target word per presentation. Below the target word are placed four pictures of which one illustrates the target word. For the children to give a correct answer, they will have to touch the picture matching the target word on the touch screen. They are asked to touch the correct picture as fast as possible. The three remaining pictures represents words (distractors) that have either the initial (two pictures) or the final (one picture) sound in common with the target word. The presentations of target words and the order of the four pictures are randomized between subjects and time points. During the test, children are allowed to ask questions concerning the pictures (e.g. what is shown on this picture?) but not regarding the target word (e.g. what is the sound of this letter?). The results from the test constitute mean response time for correct answers and number of correct answers.
Measured: 8-weeks and 18-weeks
Change in trained letter-sound correspondences accuracy (15 trials) between 8 weeks and 18 weeks, paper and pencil test
The test consists of 15 trials. In each trial, a sound corresponding to a standard or a conditional pronunciation of a letter is said out loud by the assessor. Children are instructed to identify the correct letter matching the sound from a row of four letters. Before the test trials, children will be provided with one practice trial. The 15 sounds represent both standard and conditional pronunciations of the letters a, e, o, r, u and v. Results are numbers of correct letter-sound correspondences.
Measured: 8-weeks and 18-weeks
Change in word reading accuracy (reading of 12 untrained words) between 8 weeks and 18 weeks, computer-based test
This test consists of 12 presentations of untrained words; one word per presentation. The 12 words consist of four 2-letter words, four 3-letter words and four 4-letter words.
Measured: 8-weeks and 18-weeks
Change in letter naming fluency accuracy between 8 weeks and 18 weeks
This Danish version of the Letter Naming test is based on the same principles as DIBELS Letter Naming Fluency (Good \& Kaminski, 2002). The test consists of a piece of paper (A4) with 12 rows of 10 letters (mixed upper- and lower case).
Measured: 8-weeks and 18-weeks
Change in letter-sound correspondence accuracy, Bogstaveprøve 2 ['Letter test 2'] between 8 weeks and 18 weeks
This test has been widely used in the Danish school system. The test consists of two subtests assessing simple letter-sound knowledge and vowel identification, respectively. For the purpose of the present study, only the first subtest will be administered to assess standard letter-sound knowledge.
Measured: 8-weeks and 18-weeks
Change in word reading accuracy and speed, Ordlæseprøve 1 ['Word reading test 1'] between 8 weeks and 18 weeks
This test is widely used in the Danish school system. The test consists of 78 items (preceded by two practice items) and evaluates word reading accuracy as well as efficiency.
Measured: 8-weeks and 18-weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2020
- Study start1 Sep 2020
- Primary completion19 Feb 2021
- Study completion14 Apr 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ReadingStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A three-armed randomized controlled trial
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 149 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Copenhagen
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jacob Wienecke, University of Copenhagen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04618822
- Sponsor's protocol ID
- 8018-00132B
- Acronym
- PLAYMORE
- Status last verified
- Nov 2022
- First submitted
- 26 Oct 2020
- Last updated
- 8 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Gejl AK, Malling ASB, Damsgaard L, Veber-Nielsen AM, Wienecke J. Motor-enriched learning for improving pre-reading and word recognition skills in preschool children aged 5-6 years - study protocol for the PLAYMORE randomized controlled trial. BMC Pediatr. 2021 Jan 4;21(1):2. doi: 10.1186/s12887-020-02430-0.
PubMed 33397297
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Motor-enriched Learning for Improving Pre-reading and Word Recognition Skills in Preschool Children Aged 5-6 Years
- ClinicalTrials.gov ID
- NCT04618822
- Acronym / sponsor ID
- PLAYMORE / 8018-00132B
- Conditions
- Reading
- Keywords
- motor-enriched learning, embodied learning, physically active lessons, pre-reading skills, word recognition, preschool children
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 149 participants (actual)
- Lead sponsor
- University of CopenhagenUniversity, hospital or other
- Study start
- 1 Sep 2020 (actual)
- Primary completion
- 19 Feb 2021 (actual)
- Study completion
- 14 Apr 2021 (actual)
- First posted
- 6 Nov 2020 (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 PLAYMORE study aims to investigate the effects of two interventions focusing on a close and meaningful coupling between bodily movement and academic content on early pre-reading and word recognition skills in children. Further, the study aims to compare two interventions involving either hand movements (i.e. using arms and hands) or whole-body movements (i.e. using the whole body). Potential mediating factors underlying the potential effect of bodily movement on early pre-reading and word recognition skills will be explored. The PLAYMORE study will be conducted as a three-armed randomized controlled trial including children aged five to six years recruited from four schools in the Copenhagen area, Denmark. Stratified by class, children will be randomly allocated to one of three 8-week intervention/control periods: 1) teaching involving whole-body movements, 2) teaching involving hand movements (i.e. arms and hands) or 3) teaching involving minimal motor movements (i.e. seated on a chair using paper and pencil). Outcome measurements, including pre-reading and word recognition skills, will be collected before and after the intervention period to assess the intervention effects. This study protocol follows the SPIRIT guidelines.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- A three-armed randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| Teaching involving whole-body movements | Experimental | Behavioral: Teaching involving whole-body movements |
| Teaching involving hand movements | Experimental | Behavioral: Teaching involving hand movementsi.e. arms and hands |
| teaching involving minimal motor movements | Active comparator | Behavioral: Teaching involving minimal motor movements (control)i.e. seated on a chair using paper and pencil |
Who may qualify
- Ages
- 5 to 7 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Children five to six years old who have just started school
Key exclusion criteria (2 listed)
- Children who do not speak any Danish
- Children with cognitive or physical disabilities hindering participation in the project activities
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 |
|---|---|---|
| Teaching involving whole-body movementsThe intervention consist of three 30 minutes sessions per week for eight weeks. Activities are conducted in small groups of six children and focus on the acquisition of letterforms, letter-sound correspondences and reading and spelling of short words. Activities involve whole-body movements and have been developed with the embodied learning theory in mind, linking movement closely to the learning content. | Behavioural | Teaching involving whole-body movements |
| Teaching involving hand movementsThe intervention consist of three 30 minutes sessions per week for eight weeks. Activities are conducted in small groups of six children and focus on the acquisition of letterforms, letter-sound correspondences and reading and spelling of short words. Activities involve movements using hands and arms and have been developed with the embodied learning theory in mind, linking movement closely to the learning content. | Behavioural | Teaching involving hand movements |
| Teaching involving minimal motor movements (control)The control condition consist of three 30 minutes sessions per week for eight weeks. Activities are conducted in groups of app. twelve children and focus on the acquisition of letterforms, letter-sound correspondences and reading and spelling of short words. Activities are completed seated on a chair using paper and pencil. | Behavioural | teaching involving minimal motor movements |
Primary outcome
Change from baseline in word reading speed and accuracy (reading of 18 trained words) at 8 weeks, computer-based test
Time frame: Baseline and 8-weeks
This word reading test consist of 18 presentations of targets words; one target word per presentation. Below the target word are placed four pictures of which one illustrates the target word. For the children to give a correct answer, they will have to touch the picture matching the target word on the touch screen. They are asked to touch the correct picture as fast as possible. The three remaining pictures represents words (distractors) that have either the initial (two pictures) or the final (one picture) sound in common with the target word. The presentations of target words and the order of the four pictures are randomized between subjects and time points. During the test, children are allowed to ask questions concerning the pictures (e.g. what is shown on this picture?) but not regarding the target word (e.g. what is the sound of this letter?). The results from the test constitute mean response time for correct answers and number of correct answers.
Change from baseline in trained letter-sound correspondences accuracy (15 trials) at 8 weeks, paper and pencil test
Time frame: Baseline and 8-weeks
The test consists of 15 trials. In each trial, a sound corresponding to a standard or a conditional pronunciation of a letter is said out loud by the assessor. Children are instructed to identify the correct letter matching the sound from a row of four letters. Before the test trials, children will be provided with one practice trial. The 15 sounds represent both standard and conditional pronunciations of the letters a, e, o, r, u and v. Results are numbers of correct letter-sound correspondences.
12 secondary outcomes
Change from baseline in word reading accuracy (reading of 12 untrained words) at 8 weeks, computer-based test
Time frame: Baseline and 8-weeks
Change from baseline in letter naming fluency accuracy at 8 weeks
Time frame: Baseline and 8-weeks
Change from baseline in letter-sound correspondence accuracy, Bogstaveprøve 2 ['Letter test 2'] at 8 weeks
Time frame: Baseline and 8-weeks
Change from baseline in word reading accuracy and speed, Ordlæseprøve 1 ['Word reading test 1'] at 8 weeks
Time frame: Baseline and 8-weeks
Change from baseline in word reading speed and accuracy (reading of 18 trained words) at 18 weeks, computer-based test
Time frame: Baseline and 18-weeks
Change from baseline in trained letter-sound correspondences accuracy (15 trials) at 18 weeks, paper and pencil test
Time frame: Baseline and 18-weeks
Change in word reading speed and accuracy (reading of 18 trained words) between 8 weeks and 18 weeks, computer-based test
Time frame: 8-weeks and 18-weeks
Change in trained letter-sound correspondences accuracy (15 trials) between 8 weeks and 18 weeks, paper and pencil test
Time frame: 8-weeks and 18-weeks
Change in word reading accuracy (reading of 12 untrained words) between 8 weeks and 18 weeks, computer-based test
Time frame: 8-weeks and 18-weeks
Change in letter naming fluency accuracy between 8 weeks and 18 weeks
Time frame: 8-weeks and 18-weeks
Change in letter-sound correspondence accuracy, Bogstaveprøve 2 ['Letter test 2'] between 8 weeks and 18 weeks
Time frame: 8-weeks and 18-weeks
Change in word reading accuracy and speed, Ordlæseprøve 1 ['Word reading test 1'] between 8 weeks and 18 weeks
Time frame: 8-weeks and 18-weeks
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 8 Nov 2022.
- Derived from this study: PubMed 33397297Gejl AK, Malling ASB, Damsgaard L, Veber-Nielsen AM, Wienecke J. Motor-enriched learning for improving pre-reading and word recognition skills in preschool children aged 5-6 years - study protocol for the PLAYMORE randomized controlled trial. BMC Pediatr. 2021 Jan 4;21(1):2. doi: 10.1186/s12887-020-02430-0.
- 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?
A study testing Teaching involving whole-body movements and Teaching involving hand movements in people with Reading, run by University of Copenhagen at 1 site in Denmark.
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 1 inclusion and 2 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 8 Nov 2022. 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 Denmark. 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?
Change from baseline in word reading speed and accuracy (reading of 18 trained words) at 8 weeks, computer-based test (time frame: Baseline and 8-weeks). 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?
On the ClinicalTrials.gov record for NCT04618822, which also lists 1 linked publication.
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 8 Nov 2022.