NCT07729163

Brief Summary

We tested whether adding a simple, structured Body Awareness Training (BAT) program to conventional physiotherapy improves motor skills, everyday activity performance, and participation (goal achievement and satisfaction) in children with mild to moderate intellectual disability.41 children aged 8-15 years with mild or moderate intellectual disability completed the study. They were randomly assigned to receive either standard physiotherapy (control) or the same physiotherapy plus Body Awareness Training (intervention).All children received conventional physiotherapy three times per week for six weeks (18 sessions total). The physiotherapy included warm-up, range-of-motion, stretching, strengthening exercises and electrotherapy. The intervention group received an additional 30 minutes per session of Body Awareness Training during the same period. BAT activities were simple, rhythmic, and child-friendly. Both groups improved in some fine motor domains, but improvements were larger in the group that received Body Awareness Training. The BAT group showed additional significant gains in manual dexterity, balance, and running speed/agility that were not observed in the control group. Children in the BAT group reported greater improvements in everyday activity performance and higher satisfaction. The BAT group also achieved better outcomes on individualized functional goals (GAS) for several prioritized activities. Most improvements were maintained at the 10-week follow-up. Adding short, structured Body Awareness Training to routine physiotherapy may provide extra benefits for motor coordination, balance, and meaningful everyday functioning in children with mild-moderate intellectual disability. BAT exercises are low-cost, adaptable, and can be integrated into regular therapy sessions; they may help bridge improvements in motor skills to better performance and participation in daily life. Clinicians should individualize intensity and progression according to each child's abilities and stop or adapt activities if pain, excessive fatigue, or breathlessness occurs.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
41

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2025

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

August 4, 2025

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 24, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 24, 2025

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

July 22, 2026

Completed
5 days until next milestone

First Posted

Study publicly available on registry

July 27, 2026

Completed
Last Updated

July 27, 2026

Status Verified

July 1, 2026

Enrollment Period

5 months

First QC Date

July 22, 2026

Last Update Submit

July 24, 2026

Conditions

Keywords

ActivityBody awarenessIntellectual disabilityMotor performanceParticipation

Outcome Measures

Primary Outcomes (3)

  • Motor skills

    Motor skills were evaluated using the Bruininks-Oseretsky Test of Motor Proficiency, Second Edition-Short Form (BOT-2 SF). This standardized instrument assesses eight domains: fine motor precision, fine motor integration, manual dexterity, bilateral coordination, balance, running speed and agility, upper-limb coordination, and strength. Total scores are calculated based on subtest performance, where higher scores represents superior motor proficiency and better physical coordination.

    Baseline (T0), immediately post-intervention at 6 weeks (T1), and 10-week follow-up (T2).

  • Activity performance

    Self-perceived performance and satisfaction in everyday activities were evaluated using the Canadian Occupational Performance Measure (COPM). Through a collaborative clinician-led interview, children and parents identified five priority tasks in the domains of self-care, productivity, or leisure. Each activity was rated on a scale from 1 (lowest) to 10 (highest), where higher scores indicate greater perceived performance and higher satisfaction with the ability to perform meaningful daily routines.

    Baseline (T0), immediately post-intervention at 6 weeks (T1), and 10-week follow-up (T2).

  • Participation

    Individualized participation goals were collaboratively set by the child, parents, and the evaluating physiotherapist prior to the intervention. Goal achievement was rated on a 5-point scale from -2 (much less than expected) to +2 (much better than expected), with 0 representing the expected level of attainment. GAS provides a standardized method to quantify meaningful, individualized changes in participation and functional goal achievement following the intervention.

    Baseline (T0), immediately post-intervention at 6 weeks (T1), and 10-week follow-up (T2).

Study Arms (2)

Control Group

ACTIVE COMPARATOR

Participants in this arm received a conventional physiotherapy program consisting of strengthening, stretching, and range-of-motion (ROM) exercises, along with electrotherapy as clinically indicated. The program was delivered in 60-minute sessions, three times per week for six weeks (18 sessions total). All exercises were individualized by a licensed physiotherapist based on each child's age, functional capacity, and tolerance.

Other: Conventional Physiotherapy

Intervention group

EXPERIMENTAL

Participants in this arm received the same conventional physiotherapy program as the control group (strengthening, stretching, ROM exercises, and electrotherapy), augmented with a structured Body Awareness Training (BAT) module. The BAT protocol included body scanning, breathing awareness, cross-body coordination, rhythmic tactile stimulation, postural alignment, and weight-shifting activities. The program was delivered in 90-minute sessions (60 minutes conventional + 30 minutes BAT), three times per week for six weeks (18 sessions total), individualized by a licensed physiotherapist.

Other: Body Awareness Training and Conventional Physiotherapy

Interventions

This intervention combines a 60-minute conventional physiotherapy protocol (range of motion, stretching, strengthening, and electrotherapy) with a 30-minute structured Body Awareness Training (BAT) module. The BAT component consists of six specific elements: body scanning in the supine position, rhythmic opening/closing coordination exercises, tactile "catwalk" massage for skin-brain connection, standing body alignment practice focused on the vertical midline, weight-transfer activities within stability limits, and breathing-wave integration. The total session duration is 90 minutes, delivered three times per week for six weeks (18 sessions), and is individualized based on the participant's functional capacity and clinical tolerance.

Intervention group

This intervention consists of a 60-minute individualized physiotherapy program including active and active-assisted range of motion (ROM) exercises, static stretching of major muscle groups (held for 20-30 seconds), and functional strengthening exercises (e.g., glute bridges, mini-squats, and step-ups). Electrotherapy is applied as needed for muscle activation or circulatory support. The protocol is delivered three times per week for six weeks (18 sessions total), with exercises progressed from 1 set of 8-10 repetitions to 2 sets of 10-15 repetitions based on the child's performance and fatigue levels.

Control Group

Eligibility Criteria

Age8 Years - 15 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Age between 8 and 15 years
  • Mild or moderate intellectual disability with sufficient cognitive and verbal communication ability to understand and follow instructions.

You may not qualify if:

  • Receiving any treatment other than conventional physiotherapy within the previous 6 months
  • Having any orthopedic disorder or history of orthopedic surgery
  • Communication problems in parents or caregivers
  • Absence from more than three treatment sessions.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cyprus International University

Mersin, Mersin, 99040, Turkey (Türkiye)

Location

Related Publications (9)

  • Ozkan Z, Kale R. Investigation of the effects of physical education activities on motor skills and quality of life in children with intellectual disability. Int J Dev Disabil. 2021 Sep 27;69(4):578-592. doi: 10.1080/20473869.2021.1978267. eCollection 2023.

    PMID: 37346264BACKGROUND
  • Wuang YP, Wang CC, Huang MH, Su CY. Profiles and cognitive predictors of motor functions among early school-age children with mild intellectual disabilities. J Intellect Disabil Res. 2008 Dec;52(12):1048-60. doi: 10.1111/j.1365-2788.2008.01096.x. Epub 2008 Jun 16.

    PMID: 18557969BACKGROUND
  • Vuijk PJ, Hartman E, Scherder E, Visscher C. Motor performance of children with mild intellectual disability and borderline intellectual functioning. J Intellect Disabil Res. 2010 Nov;54(11):955-65. doi: 10.1111/j.1365-2788.2010.01318.x. Epub 2010 Sep 20.

    PMID: 20854287BACKGROUND
  • Schalock RL, Luckasson R, Tasse MJ. An Overview of Intellectual Disability: Definition, Diagnosis, Classification, and Systems of Supports (12th ed.). Am J Intellect Dev Disabil. 2021 Nov 1;126(6):439-442. doi: 10.1352/1944-7558-126.6.439. No abstract available.

    PMID: 34700345BACKGROUND
  • Li Y, Wu X, Ye D, Zuo J, Liu L. Research progress on the relationship between fine motor skills and academic ability in children: a systematic review and meta-analysis. Front Sports Act Living. 2025 Jan 9;6:1386967. doi: 10.3389/fspor.2024.1386967. eCollection 2024.

    PMID: 39850871BACKGROUND
  • King G, Williams L, Hahn Goldberg S. Family-oriented services in pediatric rehabilitation: a scoping review and framework to promote parent and family wellness. Child Care Health Dev. 2017 May;43(3):334-347. doi: 10.1111/cch.12435. Epub 2017 Jan 12.

    PMID: 28083952BACKGROUND
  • Kavanagh H, Issartel J, Meegan S, Manninen M. Exploring the motor skill proficiency barrier among children with intellectual disabilities: Analysis at a behavioural component level. PLoS One. 2023 Nov 28;18(11):e0288413. doi: 10.1371/journal.pone.0288413. eCollection 2023.

    PMID: 38015908BACKGROUND
  • Eyssen IC, Steultjens MP, Oud TA, Bolt EM, Maasdam A, Dekker J. Responsiveness of the Canadian occupational performance measure. J Rehabil Res Dev. 2011;48(5):517-28. doi: 10.1682/jrrd.2010.06.0110.

    PMID: 21674402BACKGROUND
  • Ahn SN. A Systematic Review of Interventions Related to Body Awareness in Childhood. Int J Environ Res Public Health. 2022 Jul 22;19(15):8900. doi: 10.3390/ijerph19158900.

    PMID: 35897271BACKGROUND

MeSH Terms

Conditions

Intellectual DisabilityMotor Activity

Condition Hierarchy (Ancestors)

Neurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsNeurodevelopmental DisordersMental DisordersBehavior

Study Officials

  • Mehmet Miçooğulları, Prof. Dr.

    Cyprus International University

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
Outcome assessments were performed at baseline (T0), post-treatment (T1), and 10-week follow-up (T2) by a licensed physiotherapist who was completely blinded to group allocation and had no involvement in delivering the intervention protocols. To maintain the integrity of the blinding, the treating physiotherapist-who was responsible for delivering both the conventional and body awareness interventions-did not participate in any part of the assessment or data entry process. During the data analysis phase, the principal investigators conducted the statistical analysis on de-identified datasets to ensure that the evaluation of results remained independent of the treatment delivery.
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Asst. Prof. Dr.

Study Record Dates

First Submitted

July 22, 2026

First Posted

July 27, 2026

Study Start

August 4, 2025

Primary Completion

December 24, 2025

Study Completion

December 24, 2025

Last Updated

July 27, 2026

Record last verified: 2026-07

Data Sharing

IPD Sharing
Will share

Individual participant data that underlie the results reported in this study-including de-identified demographic information, anthropometric measurements, and pre- and post-intervention scores for motor skills (BOT-2 SF), activity performance (COPM), and participation (GAS)-will be shared. This includes data presented in the text, tables, and figures, along with the study protocol and intervention manual.

Shared Documents
STUDY PROTOCOL, SAP
Time Frame
Data and supporting documents will be made available beginning immediately following publication and will remain accessible for a period of three years.
Access Criteria
IPD and supporting documents will be shared with researchers who provide a methodologically sound proposal to achieve the aims of the approved proposal. Proposals should be directed to the corresponding author (mmicoogullari@ciu.edu.tr). To gain access, data requestors will be required to sign a data access agreement.

Locations