NCT05998083

Brief Summary

The aim of the study is to examine the effect of purposeful balance and coordination exercises on attention and quality of life in children diagnosed with special learning disabilities.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
45

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2021

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2021

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2022

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

August 9, 2023

Completed
9 days until next milestone

First Posted

Study publicly available on registry

August 18, 2023

Completed
Last Updated

August 18, 2023

Status Verified

August 1, 2023

Enrollment Period

2 months

First QC Date

August 9, 2023

Last Update Submit

August 16, 2023

Conditions

Outcome Measures

Primary Outcomes (4)

  • The Quality of Life Scale for Children (QoL-C)

    Quality of Life Scale for Children, parent form for children or adolescents 2-4, 5-7, 8-12, 13-18 years old, and self for children or adolescents 5-7, 8-12, 13-18 years old It consists of a total of 7 forms, including a notification form. This scale questions the last month of children and adolescents. It was developed as a Likert-type scale with 3 options for children aged 5-7 and 5 options for children and adolescents aged 8-18. Items are scored between 0-100. The answer to the question is scored 100 if it is marked as never, 75 if it is marked as rarely, 50 if it is marked as sometimes, 25 if it is marked as often, and 0 if it is marked as almost always. The total score is obtained by summing the scores and dividing by the number of items filled. The score obtained is directly proportional to the quality of life.

    10 weeks

  • Leisure Activity Questionnaire for Children (CPAQ)

    The form was filled by the children and their exercise levels were determined by calculations. MET values were classified as low, medium, high and moderately high. Low-intensity activities of 3 METs or less per hour are moderate and high-intensity activities of 3 METs and above. It is considered as moderate (3-5.9 MET), high intensity (6 MET and above), and medium-high intensity (3 MET and above).

    10 weeks

  • bourdon attention test

    Bourdon Test (also dubbed a/b/q Test, ABQ) is an approach to measure focus and attentiveness that requires its taker to spot and cross out the query chars a, b and q in a potpourri of letters. The test consists of two forms. The first is to find and mark certain letters among mixed book letters; the second one is in the form of finding and marking certain figures among the figures given as mixed. There are a total of 660 letters in the letter form of the test. In the letter form, certain letters are required to be found among the letters. There is no template created, and the practitioner can choose the letters or shapes he wants and ask the children to mark them, so that the practitioner can create his own template.

    10 weeks

  • bruninks oserertsky engine proficiency test-2(BOT-2)

    BOT-2 measures fine and gross motor proficiency, with subtests that focus on stability, mobility, strength, coordination, and object manipulation. The test is tailored to school-aged children and young adults among the ages of 4-21 years, who have varying motor control abilities ranging from normal to mild or moderate.In both the BOT-2 short form (SF) this scale is used to transform the standard score to final categories (1 - well below average; 2 - below average; 3 - average; 4 - above average; 5 - well above average).The four motor-area composite standard scores, discussed below, range from 27 on Manual Coordination to 61 on Fine Manual Control.

    10 weeks

Study Arms (2)

control group

ACTIVE COMPARATOR

continued their normal education and physiotherapy

Other: control

experimental group

EXPERIMENTAL

they continued their normal training and physiotherapy, in addition, purposeful balance and coordination exercises were given for 40 minutes a day, 2 days a week for 8 weeks.

Other: exercise

Interventions

In addition to the individual support training program, the exercise group was given a balance and coordination exercise protocol including 40 minutes, 2 days a week. These exercises are: It consisted of warm-up (10 minutes), purposeful balance and coordination exercises (20 minutes), and cool-down (10 minutes) exercises. Balance and coordination exercises with purpose were created with a series of exercises based on copying the shape of the blocks on the cards placed at the beginning of a track consisting of stations at the end of the track. The stations were composed of "hopscotch station", "tandem walking station in one line", "bounce station", "bucketing ping pong balls station" and "eight running stations".

experimental group
controlOTHER

The control group continued only the individual support education program.

control group

Eligibility Criteria

Age7 Years - 15 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Being diagnosed with Special Learning Disabilities
  • To be between the ages of 7-15
  • To attend the special education and rehabilitation center and individual support training program regularly.
  • Not having exercise intolerance or any disease that prevents exercise
  • The child's willingness to participate in the study and the consent of the parent to participate in the study

You may not qualify if:

  • Having physical or psychological disorders in addition to the diagnosis of Special Learning Disabilities (ADHD, etc.)
  • Being diagnosed with Special Learning Disabilities and not complying with the age range
  • Not attending the individual training program regularly
  • Parents not giving consent for the child to participate in the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Özel Eğitim Merkezi

Istanbul, Turkey (Türkiye)

Location

Related Publications (6)

  • Blanchet M, Assaiante C. Specific Learning Disorder in Children and Adolescents, a Scoping Review on Motor Impairments and Their Potential Impacts. Children (Basel). 2022 Jun 15;9(6):892. doi: 10.3390/children9060892.

    PMID: 35740829BACKGROUND
  • Hallawell B, Stephens J, Charnock D. Physical activity and learning disability. Br J Nurs. 2012 May 24-Jun 13;21(10):609-12. doi: 10.12968/bjon.2012.21.10.609.

    PMID: 22875298BACKGROUND
  • Bluechardt MH, Wiener J, Shephard RJ. Exercise programmes in the treatment of children with learning disabilities. Sports Med. 1995 Jan;19(1):55-72. doi: 10.2165/00007256-199519010-00005.

    PMID: 7740247BACKGROUND
  • Fathi Azar E, Mirzaie H, Jamshidian E, Hojati E. Effectiveness of perceptual-motor exercises and physical activity on the cognitive, motor, and academic skills of children with learning disorders: A systematic review. Child Care Health Dev. 2023 Nov;49(6):1006-1018. doi: 10.1111/cch.13111. Epub 2023 Mar 7.

    PMID: 36872844BACKGROUND
  • Maiano C, Hue O, Morin AJS, Lepage G, Tracey D, Moullec G. Exercise interventions to improve balance for young people with intellectual disabilities: a systematic review and meta-analysis. Dev Med Child Neurol. 2019 Apr;61(4):406-418. doi: 10.1111/dmcn.14023. Epub 2018 Sep 19.

    PMID: 30230530BACKGROUND
  • Punar E, Sevgin O. Effect of goal-directed perceptual-motor exercise on children with specific learning difficulties: a randomized controlled trial. BMC Pediatr. 2024 Dec 19;24(1):820. doi: 10.1186/s12887-024-05309-6.

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Interventions

Exercise

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior DisordersNeurodevelopmental DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Elif PUNAR

    Uskudar University

    STUDY CHAIR
  • Turgay ALTUNALAN

    Karadeniz Technical University

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: In addition to the individual training program they received from the special training center, the experimental group was given goal-oriented balance and coordination exercises for 40 minutes, 2 days a week.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
assistant professor

Study Record Dates

First Submitted

August 9, 2023

First Posted

August 18, 2023

Study Start

September 1, 2021

Primary Completion

November 1, 2021

Study Completion

April 1, 2022

Last Updated

August 18, 2023

Record last verified: 2023-08

Data Sharing

IPD Sharing
Will not share

Locations