- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04618822
Play-based Motor-Cognitive Training for Improved Reading (PLAYMORE)
November 7, 2022 updated by: Jacob Wienecke, University of Copenhagen
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.
Study Overview
Status
Completed
Conditions
Study Type
Interventional
Enrollment (Actual)
149
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Copenhagen, Denmark, 2200
- University of Copenhagen
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
5 years to 7 years (Child)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Children five to six years old who have just started school
Exclusion Criteria:
- Children who do not speak any Danish
- Children with cognitive or physical disabilities hindering participation in the project activities
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Teaching involving whole-body movements
|
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.
|
|
Experimental: Teaching involving hand movements
i.e. arms and hands
|
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.
|
|
Active Comparator: teaching involving minimal motor movements
i.e. seated on a chair using paper and pencil
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
Baseline and 8-weeks
|
|
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.
|
Baseline and 8-weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change from baseline in word reading accuracy (reading of 12 untrained words) at 8 weeks, computer-based test
Time Frame: Baseline and 8-weeks
|
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.
|
Baseline and 8-weeks
|
|
Change from baseline in letter naming fluency accuracy at 8 weeks
Time Frame: Baseline and 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).
|
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
|
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.
|
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
|
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.
|
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
|
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.
|
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
|
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.
|
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
|
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.
|
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
|
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.
|
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
|
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.
|
8-weeks and 18-weeks
|
|
Change in letter naming fluency accuracy between 8 weeks and 18 weeks
Time Frame: 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).
|
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
|
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.
|
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
|
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.
|
8-weeks and 18-weeks
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in 1-back task accuracy and reaction time
Time Frame: Baseline, 8-weeks and 18-weeks
|
This 1-back task is constructed of representations of symbols (car, cloud, globe, note, headphones, airplane, plate, key, eye and bicycle); one symbol is presented at the time.
|
Baseline, 8-weeks and 18-weeks
|
|
Change in digit span forwards and backwards accuracy (number of correctly remembered sequences and the number of digits in the longest correctly remembered sequence)
Time Frame: Baseline, 8-weeks and 18-weeks
|
The digit span task is a subtest of the Wechsler Intelligence Scale for Children - fourth edition (WISC-IV) (Wechsler, 2003) and is used to assess auditory working memory, attention, and concentration.
The test consists of two subtests; digit span forward and digit span backwards.
|
Baseline, 8-weeks and 18-weeks
|
|
Intrinsic motivation questionnaire
Time Frame: Four times during study completion, immediately after one session in week two, four, six and eight
|
Modified version of Intrinsic Motivation Inventory (IMI) (McAuley, Duncan, & Tammen, 1989).
The original items of the IMI are translated into Danish using a translation-backtranslation process (Streiner & Norman, 2008).
The inventory is reduced to six questions related to intrinsic motivation (question 1-3) and feeling of competences (question 4-6).
|
Four times during study completion, immediately after one session in week two, four, six and eight
|
|
Change in Flamingo balance test, balance on one leg (sum of attempts with both legs; lower scores indicate better performance)
Time Frame: Baseline, 8-weeks and 18-weeks
|
The flamingo balance test is a standardized test that assesses the ability to balance successfully on one leg (Adam, C., Klissouras, V., Ravazzolo, M., Renson, R., & Tuxworth, 1988).
|
Baseline, 8-weeks and 18-weeks
|
|
Change in 9-hole pegboard (speed)
Time Frame: Baseline, 8-weeks and 18-weeks
|
The 9-hole pegboard test is a standardized test which has previously been used in children to evaluate fine motor skills (Longcamp et al., 2005; Smith, Hong, & Presson, 2000).
|
Baseline, 8-weeks and 18-weeks
|
|
Flamingo balance test, balance on one leg (sum of attempts with both legs; lower scores indicate better performance)
Time Frame: Baseline
|
The flamingo balance test is a standardized test that assesses the ability to balance successfully on one leg (Adam, C., Klissouras, V., Ravazzolo, M., Renson, R., & Tuxworth, 1988).
|
Baseline
|
|
9-hole pegboard (speed)
Time Frame: Baseline
|
The 9-hole pegboard test is a standardized test which has previously been used in children to evaluate fine motor skills (Longcamp et al., 2005; Smith, Hong, & Presson, 2000).
|
Baseline
|
|
Letter-sound correspondence accuracy, Bogstaveprøve 2 ['Letter test 2']
Time Frame: Baseline
|
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.
|
Baseline
|
|
Word reading accuracy and speed, Ordlæseprøve 1 ['Word reading test 1']
Time Frame: Baseline
|
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.
|
Baseline
|
|
Letter naming fluency accuracy
Time Frame: Baseline
|
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).
|
Baseline
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
September 1, 2020
Primary Completion (Actual)
February 19, 2021
Study Completion (Actual)
April 14, 2021
Study Registration Dates
First Submitted
October 26, 2020
First Submitted That Met QC Criteria
November 1, 2020
First Posted (Actual)
November 6, 2020
Study Record Updates
Last Update Posted (Actual)
November 8, 2022
Last Update Submitted That Met QC Criteria
November 7, 2022
Last Verified
November 1, 2022
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 8018-00132B
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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