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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
149

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

  • Denmark
      • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Teaching involving whole-body movements
Behavioral: 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
Behavioral: Teaching involving hand 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 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
Behavioral: 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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Copenhagen

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.

General Publications

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 1, 2020

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 19, 2021

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 14, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 26, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 1, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 6, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 8, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 7, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2022

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

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