NCT05742451

Brief Summary

Purpose: To determine the effect of 8-week kids yoga training on balance, reaction time and agility on children diagnosed with attention deficit hyperactivity disorder (ADHD). Method: A randomized controlled trial. The intervention (kids yoga) was an 8-week program administered to children attending a special education center by a yoga instructor occupational therapist. Outcomes included Pediatric Balance Scale, Bruininks-Oseretsky Motor Proficiency Test-Short Form, and Microgate Witty SEM System assessed at baseline and at the end of 8th week.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
17

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2022

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 15, 2022

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 17, 2022

Completed
13 days until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2022

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

December 30, 2022

Completed
2 months until next milestone

First Posted

Study publicly available on registry

February 24, 2023

Completed
Last Updated

February 27, 2023

Status Verified

February 1, 2023

Enrollment Period

2 months

First QC Date

December 30, 2022

Last Update Submit

February 24, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • Pediatric Balance Scale (PBS)

    The Pediatric Balance Scale is an assessment that is used to assess functional balance skills in school-aged children. The scale consists of 14 items that are scored from 0 points (lowest function) to 4 points (highest function) with a maximum score of 56 points. The scale consists of sitting to standing, standing to sitting, transfers, standing unsupported, sitting unsupported, standing with eyes closed, standing with feet together, standing with one foot in front, standing on one foot, turning 360 degrees, turning to look behind, retrieving object from floor, placing alternate foot on stool, reaching forward with outstretched arm. In the study; ın the pedıatrıc balance scale standing with one foot in front, standing on one foot, turning 360 degrees, and placing alternate foot on stool sub-scales was applıed.

    20 minutes

Secondary Outcomes (1)

  • Bruininks-Oseretsky Test of Motor Proficiency-Short Form (BOT-SF)

    20 minutes

Other Outcomes (1)

  • Microgate Witty SEM System

    5 minutes

Study Arms (2)

intervention group

ACTIVE COMPARATOR

The kids yoga was applied to the intervention group for 8 weeks, once a week (8 sessions), 40 minutes per session, by a yoga instructor occupational therapist.

Other: kids yoga

Control group

NO INTERVENTION

The control group was evaluated at 8-week intervals.

Interventions

The kids yoga was applied to the intervention group for 8 weeks, once a week (8 sessions), 40 minutes per session, by a yoga instructor occupational therapist. Kids yoga training included: 5-minute warm-up consisting of jogging, jumping, stretching, relaxation exercises; 20 minutes of asanas (positions) consisting of standing, sitting, prone, supine postures and pranayamas (breathing exercises) consisting of vigorous inspiration and expiration, slow and rhythmic alternating nostril breathing; 10-minute yogic games about balance, reaction time and agility; meditation with focus for 5 minutes with resuscitation techniques.

intervention group

Eligibility Criteria

Age6 Years - 10 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • The participants were between the ages of 6-10
  • Received an occupational therapy treatment program

You may not qualify if:

  • Participants had a different diagnosis such as autism spectrum disorder, asperger's syndrome, pervasive developmental disorder.
  • Participants had an additional psychiatric problem
  • Participants had a serious medical condition (for example, severe cerebral palsy) or intellectual disability (IQ \< 70) sought specialist help for sleep problems was determined as having a positive screening test for obstructive sleep apnea.
  • Participants had excessive behavioral disorders incompatible with group participation.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cemre Bafralı

Ankara, Altındağ, 6050, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior DisordersNeurodevelopmental DisordersMental Disorders

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: A Randomized Controlled Trial
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer

Study Record Dates

First Submitted

December 30, 2022

First Posted

February 24, 2023

Study Start

April 15, 2022

Primary Completion

June 17, 2022

Study Completion

June 30, 2022

Last Updated

February 27, 2023

Record last verified: 2023-02

Data Sharing

IPD Sharing
Will not share

Locations