Home » Trials » SLCTR/2019/022


Effect of Fine Motor Skill competence training on classroom activity performance of children with Down syndrome: A cluster randomized controlled trial

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SLCTR Registration Number

SLCTR/2019/022


Date of Registration

10 Jul 2019

The date of last modification

Jul 10, 2019



Application Summary


Scientific Title of Trial

Effect of Fine Motor Skill competence training on classroom activity performance of children with Down syndrome: A cluster randomized controlled trial


Public Title of Trial

Effect of hand skill competence training on classroom activity performance of children with Down syndrome


Disease or Health Condition(s) Studied

Down syndrome


Scientific Acronym

None


Public Acronym

None


Brief title

Parent administered intervention to improve fine motor skills of children with Down syndrome


Universal Trial Number

U1111-1224-5991


Any other number(s) assigned to the trial and issuing authority

p/217/12/2018:ERC Ragama


Trial Details


What is the research question being addressed?

‘Does Fine Motor Skill competence training of children with Down syndrome affect their performance on classroom activities?’


Type of study

Interventional


Study design

Allocation

Randomized controlled trial


Masking

Masking not used


Control

Standard therapy/practice


Assignment

Other


Purpose

Supportive care


Study Phase

Not Applicable


Intervention(s) planned

The study setting will be government schools in Matara district where children with Down syndrome are studying but the intervention will be administered in child’s own home.

A cluster will be defined as ‘a government school having children with Down syndrome in Matara district’

Method of randomization is cluster randomization. The clusters will be assigned as intervention and control groups by simple randomization using a random number table.

The intervention will include two major activity areas as warm-up activities and fine motor activities. Warm up activities will be practiced prior to fine motor activities.

There will be two sets of warm up activities and four fine motor activities to be practiced as follows.

There will be three sets of activities for two weeks each as mentioned below.

1st and 2nd week: Two warm up activities and four fine motor activities

3rd and 4th week: Two warm up activities and four fine motor activities

5th and 6th weeks: Two warm up activities and four fine motor activities

The above activities will be repeated for the intervention group for a further 6 weeks.

Parents will be trained on how to administer the intervention during a half-day session.

Parent (Principal caregiver) will deliver the intervention to the child by practice of the above activities with the child once a day for 30 min each. The intervention will be administered four days per week on a one-to-one basis for 12 weeks for intervention group and 6 weeks for control group.

Standard therapy will be the usual school activities conducted in the classroom by teachers and will include:

1.Pencil work- write letters and numbers, draw pictures

2.Scissor work- cut a paper along a line/circle/square 3.Glue work-paste pieces of paper inside the given pictures 4.Reading and singing. 5.Colouring pictures

Standard therapy is common to both groups in the classrooms by the class teacher.

In addition to the standard activities the intervention group will receive exercises to be done at home under the supervision of the caregiver to improve fine motor skills. The activities in the intervention of fine motor skills will improve: Finger strength, finger opposition, in-hand manipulation, finger extension & flexion, reaching, coordination, wrist stability and arches Fine Motor activities in the intervention include: 1.Make a clay ball 2.Drawing on the wall 3.Tightly hold the ribbon 4.Putting coins into a box 5.Squeezing a sponge 6.Clay work (basic) 7.Rubber band hand 8.Making a string beads 9.Clay work (Advance) 10.Put cloth pegs around the paper plate 11.Cut the paper using the scissor 12.Use pencil sharpener

During the first six weeks of the trial, intervention group will receive both the intervention and standard therapy while the control group will only receive standard therapy.

During the second six weeks both intervention group and the control group will receive the intervention and standard therapy.


Inclusion criteria

  • Children with a confirmed diagnosis of Down Syndrome and having fine motor deficiency

  • Children aged between 6-9 years

  • Both male and female children.

  • Children with no visual impairments, medical or genetic conditions beyond those associated with Down Syndrome.

  • Absence of a diagnosis of a co-existing autism spectrum disorder as reported by the parents

  • Student who attends a regular or special education class in a government school in the Matara district

  • Children with a principal caregiver who is willing to get involved actively in implementation of the intervention.


Exclusion criteria

  • Children with DS who do not have fine motor deficiency.


Primary outcome(s)

1.

Improvement of fine motor skills after 12 weeks of intervention application using Outcome measure: Peabody Developmental Motor Scale-2 (PDMS-2) Follow-up assessment (during the period of intervention) which is a different assessment carried out to check and compare the progress of the two group once the intervention has started.

[

PDMS-2: At the beginning of the trial (at recruitment), at the end of the 6th week after introducing the intervention and at the end of the intervention (12th week).

Follow-up Assessment at the end of 4th, 6th,10th and 12th weeks of introducing the intervention

]

Secondary outcome(s)

1.

Improvement of classroom activity performances using Classroom Activity Performance Assessment (CAPA)

[

CAPA: At recruitment, 6th week and 12th week after introducing the intervention

]

Target number/sample size

60 (30 in each arm)


Countries of recruitment

Sri Lanka


Anticipated start date

2019-08-15


Anticipated end date

2019-12-01


Date of first enrollment


Date of study completion


Recruitment status

Pending


Funding source

Self funding


Regulatory approvals

not applicable



State of Ethics Review Approval


Status

Approved


Date of Approval

2019-03-12


Approval number

P/217/12/2018


Details of Ethics Review Committee

Name: Ethics Review Committee of the Faculty of Medicine, University of Kelaniya.
Institutional Address:Ethics Review Committee, Faculty of Medicine, University of Kelaniya, PO Box 06, Thalagolla Road, Ragama, Sri Lanka
Telephone:+94-112961267, +94-112961000
Email: erckelaniva@gmail.com

Contact & Sponsor Information


Contact person for Scientific Queries/Principal Investigator

Sajee Anuradha Gamage
Occupational therapist
1. General hospital, Matara
041 2222261-190
+94-777527341

anuotsg@gmail.com

Contact Person for Public Queries

Prof. Rajitha Wickremasinghe
Professor
Department of Public Health, Faculty of Medicine, University of Kelaniya, Ragama, Sri Lanka
+94-11-2953411 +94-11-2961000 ext 40

+94-11-2958337
arwicks@sltnet.lk


Primary study sponsor/organization

Sajee Anuradha Gamage
Occupational therapist
General hospital, Matara
0777527341

anuotsg@gmail.com

Secondary study sponsor (If any)

None





Trial Completion details


Do the investigators plan to share identified individual clinical trial participant-level data (IPD)?

No


IPD sharing plan description


Study protocol available

No


Protocol version and date

Not Available


Protocol URL

Not Available


Results summary available

No


Date of posting results


Date of study completion


Final sample size


Date of first publication


Link to results


Brief summary of results