Testing a physiotherapy programme to improve motor skills and quality of life in children with autism
| ISRCTN | ISRCTN34436540 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN34436540 |
| Secondary identifying numbers | UKM PPI/111/8 |
- Submission date
- 23/07/2025
- Registration date
- 24/09/2025
- Last edited
- 24/09/2025
- Recruitment status
- No longer recruiting
- Overall study status
- Ongoing
- Condition category
- Mental and Behavioural Disorders
Plain English summary of protocol
Background and study aims
Autism Spectrum Disorder (ASD) is a neurodevelopmental condition that affects communication, social interaction, motor coordination, and behavior. This condition results in reduced physical activity and poor quality of life (QoL). Children with ASD frequently experience motor impairments that hinder daily functioning, participation in play, and social engagement. Although structured physiotherapy interventions have gained attention for improving motor and psychosocial outcomes, most existing programs remain unstructured, lack theoretical grounding and are not tailored to the unique sensory and behavioral needs of children with ASD. Moreover, many interventions are developed in high-resource Western contexts, raising questions about their relevance and applicability in Malaysian community-based rehabilitation settings. Addressing this gap requires a structured and contextually grounded physiotherapy intervention that is both scalable and evidence-based. This study aims to evaluate the effectiveness of a 12-week structured physiotherapy program in improving motor skills, physical activity, behavior, and quality of life in children with mild to moderate ASD.
Who can participate?
Children aged 6 to 10 years who have been diagnosed with mild to moderate Autism Spectrum Disorder (ASD) based on the Gilliam Autism Rating Scale – Third Edition (GARS-3) and who demonstrate motor difficulties as assessed by the Bruininks-Oseretsky Test of Motor Proficiency – Second Edition (BOT-2) are eligible to participate.
What does the study involve?
Participants will be randomly assigned to one of two groups: an intervention or control group. The intervention group will receive the 12-week structured physiotherapy program in addition to usual care. The control group will continue with usual care alone. The structured intervention will include warm-up activities, three structured motor skill circuits, which cover strength, endurance, coordination, balance, and flexibility and a cool-down phase. The structured physiotherapy program will be conducted over 12 weeks with sessions held twice per week. Each session will last for one hour and will be delivered in a paired format where two children participate together under guided supervision. Assessments will take place before and after the intervention using validated tools to measure motor skills, autism symptom severity, physical activity, behavior, and quality of life.
What are the possible benefits and risks of participating?
Participants in the intervention group may experience improvements in motor skills, physical activity, behavior and overall well-being. There is minimal risk associated with participation. Some children may feel fatigued or frustrated during exercises but all sessions will be supervised by trained physiotherapists and activities will be adapted to suit individual needs. Participation is voluntary, and parents may withdraw their child at any time without any consequences.
Where is the study run from?
The study is coordinated by the Faculty of Health Sciences, Universiti Kebangsaan Malaysia (UKM). Data collection will take place at PDK centres in Terengganu and Klang Valley, Children's Specialist Hospital UKM and selected community centres.
When is the study starting and how long is it expected to run for?
The overall study start date was September 2024. The study's first enrollment started in May 2025 and will run for approximately 8 months, including recruitment, intervention and data analysis phases. The completion date is projected to be January 2026.
Who is funding the study?
This study is funded through a university research grant by Universiti Kebangsaan Malaysia (UKM).
Who is the main contact?
Mrs Nazurah Alwi, nazurah@moh.gov.my
Contact information
Principal Investigator
Physiotherapy Programme, National University of Malaysia, Faculty of Health Sciences, Jalan Raja Muda Abdul Aziz
Kuala Lumpur
50300
Malaysia
| Phone | +603-9289 7602 |
|---|---|
| asfarina.zanudin@ukm.edu.my |
Public, Scientific
Marang District Health Office (Pejabat Kesihatan Daerah Marang)
Marang
21080
Malaysia
| Phone | +609-6182545 |
|---|---|
| nazurah@moh.gov.my |
Public
Clinical Psychology Programme, Faculty of Health Sciences, The National University of Malaysia, Jalan Raja Muda Abdul Aziz
Kuala Lumpur
50300
Malaysia
| Phone | +603-2687 8168 |
|---|---|
| mahadir@ukm.edu.my |
Scientific
Hospital Tunku Ampuan Besar Tuanku Aishah Rohani, Children's Specialist Hospital UKM, Jalan Yaacob Latif, Bandar Tun Razak
Kuala Lumpur
56000
Malaysia
| Phone | +603-91748104 |
|---|---|
| azizahmd@ppukm.ukm.edu.my |
Study information
| Study design | Single-blind two-arm parallel-group randomized controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Childcare/pre-school, Community, School |
| Study type | Quality of life, Efficacy |
| Participant information sheet | 47718_PIS.pdf |
| Scientific title | Effectiveness of a structured physiotherapy intervention on psychomotor and quality of life in children with mild to moderate autism spectrum disorder |
| Study acronym | STEP-ASD |
| Study objectives | To evaluate the effectiveness of a structured physiotherapy intervention on the psychomotor (motor skills, physical activity, behavior problems) and QoL among children with ASD. |
| Ethics approval(s) |
Approved 23/01/2025, Research Ethics Secretariat of the National University of Malaysia (Tingkat 1, Blok Klinikal, Hospital Canselor Tuanku Muhriz Jalan Yaacob Latif, Bandar Tun Razak, Kuala Lumpur, 56000, Malaysia; +603-9145 5046 / 9145 5048; sepukm@ukm.edu.my), ref: JEP-2024-1127 |
| Health condition(s) or problem(s) studied | Motor skills problem among children with Autism Spectrum Disorder (ASD). |
| Intervention | Randomization of participants will be conducted using randomization.com, with stratification by age (6–10 years), ASD severity (GARS-3) and gender. Group allocation will be handled by an independent research team member not involved in assessments. Outcome assessors will be blinded to group allocation to ensure single-blinded evaluation. The intervention group will receive a structured physiotherapy intervention in addition to usual care. This intervention will be delivered by the main researcher, following the FITT principle (Frequency, Intensity, Time, Type) over 12 weeks, with two sessions per week and each session lasting for 1 hour. The program is designed to improve motor skills, physical activity, behavior, and quality of life in children with mild to moderate Autism Spectrum Disorder (ASD). Each session will consist of a warm-up, three structured motor skill circuits targeting strength, endurance, coordination, balance and flexibility and a cool-down phase. Exercise intensity will be set at 10 repetitions for motor skills and strength exercises, with aerobic activity guided by a Borg scale rating of 13 in accordance with ACSM (2003) guidelines. Sessions will be conducted in pairs, incorporating child preferences and rewarding effort with cognitive play activities. Progress will be monitored through attendance tracking and performance logs. The control group will continue receiving usual care only, which may include consultations with pediatricians, therapists and educational services. The type and frequency of usual care will be documented and monitored throughout the study to ensure consistency in comparison. |
| Intervention type | Other |
| Primary outcome measure | Motor skills measured using the Bruininks-Oseretsky Test of Motor Proficiency – Second Edition (BOT-2) at baseline at Week 0 and again post-intervention at approximately Week 12 with a permissible window of up to one week after the intervention ends |
| Secondary outcome measures | The following secondary outcome measures will be assessed at baseline (Week 0) and after the 12-week intervention period (Week 12) with a permissible window of up to one week after the intervention ends: 1. Autism symptom severity will be measured using the Gilliam Autism Rating Scale – Third Edition (GARS-3) 2. Physical activity level will be assessed using the parent-reported Godin-Shephard Leisure Time Exercise Questionnaire (GLTEQ) 3. Behavioural problems will be measured using the parent-reported Child Behavior Checklist (CBCL) 4. Health-related quality of life will be evaluated using the parent-reported Pediatric Quality of Life Inventory (PedsQL) |
| Overall study start date | 17/09/2024 |
| Completion date | 03/01/2026 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Lower age limit | 6 Years |
| Upper age limit | 10 Years |
| Sex | Both |
| Target number of participants | 64 |
| Key inclusion criteria | 1. Children aged 6 to 10 years 2. Diagnosed with Autism Spectrum Disorder (ASD) of mild to moderate severity, based on the Gilliam Autism Rating Scale – Third Edition (GARS-3) 3. Exhibiting motor difficulties, as assessed by the Bruininks-Oseretsky Test of Motor Proficiency – Second Edition (BOT-2) 4. Parent or legal guardian able to provide written informed consent |
| Key exclusion criteria | 1. Presence of other neurological or developmental conditions such as epilepsy, Attention-Deficit/Hyperactivity Disorder (ADHD) or cerebral palsy 2. Physical disabilities resulting from head injuries or other acquired conditions that interfere with participation in motor-based interventions 3. Currently involved in another clinical trial or intensive motor-based programme 4. Unstable medical condition or recent changes in medical treatment that may affect participation |
| Date of first enrolment | 16/05/2025 |
| Date of final enrolment | 16/08/2025 |
Locations
Countries of recruitment
- Malaysia
Study participating centres
Kuala Lumpur
56000
Malaysia
Terengganu
21400
Malaysia
Terengganu
21100
Malaysia
Kuala Lumpur
50300
Malaysia
Sponsor information
University/education
Faculty of Health Sciences, Jalan Raja Muda Abdul Aziz
Kuala Lumpur
50300
Malaysia
| Phone | +603-9289 7000 |
|---|---|
| dfsk@ukm.edu.my | |
| Website | https://www.ukm.my/portalukm/ |
"ROR" |
https://ror.org/00bw8d226 |
Funders
Funder type
University/education
Government organisation / Local government
- Alternative name(s)
- Universiti Kebangsaan Malaysia (UKM), Universiti Kebangsaan Malaysia (UKM), Malaysia, ukminsta, Universiti Kebangsaan Malaysia - UKM, Universiti Kebangsaan Malaysia (Malaysia), University Kebangsaan (Malaysia), UKM
- Location
- Malaysia
Results and Publications
| Intention to publish date | 03/01/2027 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Planned publication in a peer-reviewed journal |
| IPD sharing plan | The datasets generated and analyzed during the current study will be available upon request from nazurah@gmail.com. • Type of data to be shared: identified individual participant data (IPD) underlying the main outcomes (e.g., GARS-3, BOT-2, GLTEQ, CBCL, PedsQL), along with a data dictionary, annotated case report forms, protocol, and statistical analysis plan (SAP). • Timing of availability: Upon publication of the primary outcomes, with availability within 6 months of publication and for at least 5 years thereafter. • Access criteria & process: Available upon reasonable request for non-commercial research purposes. Requests will be reviewed by the study PI and sponsor; approved requestors will sign a data access agreement outlining scope of use, security, and no re-identification. • Participant consent: Informed consent includes permission to share identified data for ethically approved research. • Anonymization: Removal of direct identifiers; generalisation/offsetting of dates; suppression where needed to prevent re-identification. • Ethical/legal restrictions: Sharing will comply with local regulations (Malaysia PDPA 2010) and institutional policies; no attempts at re-identification; no onward sharing without permission. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Other files | 13/08/2025 | No | No | ||
| Participant information sheet | 13/08/2025 | No | Yes | ||
| Protocol file | 13/08/2025 | No | No | ||
| Statistical Analysis Plan | 13/08/2025 | No | No |
Additional files
Editorial Notes
13/08/2025: Study's existence confirmed by the Research Ethics Secretariat of the National University of Malaysia
