Autism Spectrum DisorderNCT06943274
SWOC Activities on Balance, Gait and Endurance in Children With Autism Spectrum Disorder
A study testing Standardized Walking Course Activities and Common Physical Activities in people with Autism Spectrum Disorder, run by Riphah International University at 1 site in Pakistan.
Trial summary
Autism Spectrum Disorder (ASD) is a developmental disorder characterized by challenges in social communication, social interaction, repetitive behaviors, and restrictive interests. Affecting 0.2-2% of children, ASD often includes motor growth retardation, which worsens over time. Read more about this study
- Who is it for?
- Ages 8 to 12 years
- Conditions the study is for
- Autism Spectrum Disorder
- What is being tested?
- Standardized Walking Course Activities and Common Physical Activities
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 sitePakistan
- Study dates
- 15 Apr 2025to 31 May 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children with confirmed diagnosis of ASD.
- Age of patients 8 to 12 year.
- Both male and female.
- Fall less than 15 times in 30 seconds in Flamingo balance scale test.
Who cannot join
- Severe physical impairment.
- Severe intellectual impairment.
- Comorbid conditions that could prevent participation.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Pakistan1 site, 1 recruiting
- Recruiting
Rising Sun Institute
Lahore, Punjab Province, 54900
Muhammad Asif Javed, MS-PT(Neuro), 923224209422, a.javed@riphah.edu.pk
About this study
Official title: Effects of Standardized Walking Obstacle Course (SWOC) Activities on Balance, Gait and Endurance in Children With Autism Spectrum Disorder
Autism Spectrum Disorder (ASD) is a developmental disorder characterized by challenges in social communication, social interaction, repetitive behaviors, and restrictive interests.
Affecting 0.2-2% of children, ASD often includes motor growth retardation, which worsens over time. The disorder is more commonly diagnosed in boys, and its cause is believed to be genetic, with environmental stimuli potentially activating certain genes. This study aims to explore the effects of Standardized Walking Obstacle Course (SWOC) activities on balance, gait, and endurance in children with ASD, seeking to discover novel treatment techniques that could enhance clinical practices and improve motor skills in these children.
Read more
This randomized controlled trial will be conducted over 10 months, with data collected from the Lahore Autism Center and PSRD hospital in Lahore, Punjab. The sample will include 44 children with confirmed ASD, aged 8 to 12 years, divided into two groups: one undergoing SWOC activities and the other receiving conventional physiotherapy. Interventions will occur 4 days a week for 30-40 minutes each day. Pre- and post-treatment measurements will be taken using the Pediatric Balance Scale (PBS), the 6-Minute Walk Test (6MWT), and Functional Gait Assessment (FGA).
Data will be analyzed using SPSS version 24, with statistical significance set at P = 0.05.
Read the detailed description
4 weeks treatment plan.
Group A: A randomized controlled trial investigate the effect of a standard walking obstacle course activities on balance, gait and endurance in children with ASD. Activity could include navigating obstacles of varying height and width balancing on beam, stepping over hurdles and walking on different surfaces. 2-3 times for 4 weeks. Balance beam Stepping stones Hurdle Markers Soft Mats Balance activities Gait and Endurance activities
Group B: Either receive no interventions or engages in a different form of physical activities that doesn't focus on balance gait and endurance e.g standard physical education activities like walking, running climbing, jumping along with applied behavioral therapy, speech therapy and customized physical therapy. 2-3 times for 4 weeks.
- Conditions
- Autism Spectrum Disorder
- Being tested
- Standardized Walking Course Activities, Common Physical Activities
- Keywords
- Autism Spectrum Disorder, Balance, Standardized Obstacle Course, Pediatric balance scale, 6-minute walk test
- Medical subject headings
- Autism Spectrum Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standardized Walking Course ActivitiesOther
A randomized controlled trial investigate the effect of a standard walking obstacle course on balance, gait and endurance in children with ASD. Activity could include navigating obstacles of varying height and width balancing on beam, stepping over hurdles and walking on different surfaces.
- Balance activities
- Gait activities
- Endurance activities Start with easier task and end with difficulties. SWOC activities performs 2 to 3 times a week for 4weeks.
Common Physical ActivitiesOther
Either receive no interventions or engages in a different form of physical activities that doesn't focus on balance gait and endurance e.g standard physical education activities like walking, running, climbing, jumping along with applied behavioral therapy, speech therapy and customized physical therapy.
| Study group | Role | What they receive |
|---|---|---|
| Group A | Experimental | For Group A Standardized Walking Obstacle Course Activities at least 2-3 times a week during a 4-week period. Receives: Other: Standardized Walking Course Activities |
| Group B | Active comparator | For Group B other physical activities at least 2-3 times a week during a 4-week period. Receives: Other: Common Physical Activities |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pediatric Berg's balance scale for balance assessment
The Pediatric Balance Scale (PBS), a modification of Berg's Balance Scale, was developed as a balance measure for school-age children with mild to moderate motor impairments.
Scoring of PBS is from 0 to 56 and more scores means balance is good and less scores indicated poor balance.intraclass correlation coefficient (ICC) model 3,1 = 0.998 or individual items Kappa Coefficients, k = 0.87 to 1.0; Spearman Rank Correlation Coefficients, r = 0.89 to 1.0 (21).
3.8.2.
Measured: Baseline, 4th week
6-minute walk test
The 6-minute walk test is a submaximal exercise test used to quantify the functional exercise capacity in clinical populations. Test-retest reliability was undertaken in 52 subjects, and the intraclass correlation coefficient (95% confidence interval) was calculated as 0.94 (0.89-0.96).
Measured: Baseline, 4th week
Gait outcome assessment list
Gait outcome assessment is used to measure and analyze an individual's walking ability, commonly employed in clinical settings for rehabilitation assessment or functional evaluation. It involves scoring parameters like speed, stride length, cadence, and balance during walking tests. The Intraclass Correlation Coefficient (ICC) is 0.89.
Measured: Baseline, 4th week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2025
- Study start15 Apr 2025
- Primary completion15 May 2025 (estimated)
- Study completion31 May 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Autism Spectrum DisorderStudies of the same condition, open and under way.
- More trials run by Riphah International UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A randomized controlled trial performed, in which 44 children with age of 8-12 years will be taken randomly after meeting inclusion criteria. Children will be divided into two groups. Group A will receive a standard walking obstacle course (e.g balance beam, stepping stones, hurdles, soft mats, gait and endurance activities) 2-3 times a week. Group B will receive other form of physical activities such as standard physical activities (e.g walking, running, climbing, jumping) 2-3 times a week. Pre values were taken at 1st week and post values of intervention will be taken after 4th week of intervention to measure the effects of both therapies.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 44 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Kainat Subtain, MS-PPT, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06943274
- Sponsor's protocol ID
- REC/RCR/AHS/25/Kainat Subtain
- Status last verified
- Apr 2025
- First submitted
- 17 Apr 2025
- Last updated
- 24 Apr 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Biffi E, Costantini C, Ceccarelli SB, Cesareo A, Marzocchi GM, Nobile M, Molteni M, Crippa A. Gait Pattern and Motor Performance During Discrete Gait Perturbation in Children With Autism Spectrum Disorders. Front Psychol. 2018 Dec 11;9:2530. doi: 10.3389/fpsyg.2018.02530. eCollection 2018.
PubMed 30618953Rhiel S, Klay A, Keller U, van Hedel HJA, Ammann-Reiffer C. Comparing Walking-Related Everyday Life Tasks of Children with Gait Disorders in a Virtual Reality Setup With a Physical Setup: Cross-Sectional Noninferiority Study. JMIR Serious Games. 2024 Mar 18;12:e49550. doi: 10.2196/49550.
PubMed 38498048
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Standardized Walking Obstacle Course (SWOC) Activities on Balance, Gait and Endurance in Children With Autism Spectrum Disorder
- ClinicalTrials.gov ID
- NCT06943274
- Acronym / sponsor ID
- REC/RCR/AHS/25/Kainat Subtain
- Conditions
- Autism Spectrum Disorder
- Keywords
- Autism Spectrum Disorder, Balance, Standardized Obstacle Course, Pediatric balance scale, 6-minute walk test
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 44 participants (estimated)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 15 Apr 2025 (actual)
- Primary completion
- 15 May 2025 (estimated)
- Study completion
- 31 May 2025 (estimated)
- First posted
- 24 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Autism Spectrum Disorder (ASD) is a developmental disorder characterized by challenges in social communication, social interaction, repetitive behaviors, and restrictive interests.
Affecting 0.2-2% of children, ASD often includes motor growth retardation, which worsens over time. The disorder is more commonly diagnosed in boys, and its cause is believed to be genetic, with environmental stimuli potentially activating certain genes. This study aims to explore the effects of Standardized Walking Obstacle Course (SWOC) activities on balance, gait, and endurance in children with ASD, seeking to discover novel treatment techniques that could enhance clinical practices and improve motor skills in these children.
This randomized controlled trial will be conducted over 10 months, with data collected from the Lahore Autism Center and PSRD hospital in Lahore, Punjab. The sample will include 44 children with confirmed ASD, aged 8 to 12 years, divided into two groups: one undergoing SWOC activities and the other receiving conventional physiotherapy. Interventions will occur 4 days a week for 30-40 minutes each day. Pre- and post-treatment measurements will be taken using the Pediatric Balance Scale (PBS), the 6-Minute Walk Test (6MWT), and Functional Gait Assessment (FGA).
Data will be analyzed using SPSS version 24, with statistical significance set at P = 0.05.
Detailed description
4 weeks treatment plan.
Group A: A randomized controlled trial investigate the effect of a standard walking obstacle course activities on balance, gait and endurance in children with ASD. Activity could include navigating obstacles of varying height and width balancing on beam, stepping over hurdles and walking on different surfaces. 2-3 times for 4 weeks. Balance beam Stepping stones Hurdle Markers Soft Mats Balance activities Gait and Endurance activities
Group B: Either receive no interventions or engages in a different form of physical activities that doesn't focus on balance gait and endurance e.g standard physical education activities like walking, running climbing, jumping along with applied behavioral therapy, speech therapy and customized physical therapy. 2-3 times for 4 weeks.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- A randomized controlled trial performed, in which 44 children with age of 8-12 years will be taken randomly after meeting inclusion criteria. Children will be divided into two groups. Group A will receive a standard walking obstacle course (e.g balance beam, stepping stones, hurdles, soft mats, gait and endurance activities) 2-3 times a week. Group B will receive other form of physical activities such as standard physical activities (e.g walking, running, climbing, jumping) 2-3 times a week. Pre values were taken at 1st week and post values of intervention will be taken after 4th week of intervention to measure the effects of both therapies.
| Arm | Type | Receives |
|---|---|---|
| Group A | Experimental | Other: Standardized Walking Course ActivitiesFor Group A Standardized Walking Obstacle Course Activities at least 2-3 times a week during a 4-week period. |
| Group B | Active comparator | Other: Common Physical ActivitiesFor Group B other physical activities at least 2-3 times a week during a 4-week period. |
Who may qualify
- Ages
- 8 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Children with confirmed diagnosis of ASD.
- Age of patients 8 to 12 year.
- Both male and female.
- Fall less than 15 times in 30 seconds in Flamingo balance scale test.
Key exclusion criteria (3 listed)
- Severe physical impairment.
- Severe intellectual impairment.
- Comorbid conditions that could prevent participation.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Standardized Walking Course ActivitiesA randomized controlled trial investigate the effect of a standard walking obstacle course on balance, gait and endurance in children with ASD. Activity could include navigating obstacles of varying height and width balancing on beam, stepping over hurdles and walking on different surfaces. * Balance activities * Gait activities * Endurance activities Start with easier task and end with difficulties. SWOC activities performs 2 to 3 times a week for 4weeks. | Other | Group A |
| Common Physical ActivitiesEither receive no interventions or engages in a different form of physical activities that doesn't focus on balance gait and endurance e.g standard physical education activities like walking, running, climbing, jumping along with applied behavioral therapy, speech therapy and customized physical therapy. | Other | Group B |
Primary outcome
Pediatric Berg's balance scale for balance assessment
Time frame: Baseline, 4th week
The Pediatric Balance Scale (PBS), a modification of Berg's Balance Scale, was developed as a balance measure for school-age children with mild to moderate motor impairments. Scoring of PBS is from 0 to 56 and more scores means balance is good and less scores indicated poor balance.intraclass correlation coefficient (ICC) model 3,1 = 0.998 or individual items Kappa Coefficients, k = 0.87 to 1.0; Spearman Rank Correlation Coefficients, r = 0.89 to 1.0 (21). 3.8.2.
6-minute walk test
Time frame: Baseline, 4th week
The 6-minute walk test is a submaximal exercise test used to quantify the functional exercise capacity in clinical populations. Test-retest reliability was undertaken in 52 subjects, and the intraclass correlation coefficient (95% confidence interval) was calculated as 0.94 (0.89-0.96).
Gait outcome assessment list
Time frame: Baseline, 4th week
Gait outcome assessment is used to measure and analyze an individual's walking ability, commonly employed in clinical settings for rehabilitation assessment or functional evaluation. It involves scoring parameters like speed, stride length, cadence, and balance during walking tests. The Intraclass Correlation Coefficient (ICC) is 0.89.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2025.
- Background: PubMed 30618953Biffi E, Costantini C, Ceccarelli SB, Cesareo A, Marzocchi GM, Nobile M, Molteni M, Crippa A. Gait Pattern and Motor Performance During Discrete Gait Perturbation in Children With Autism Spectrum Disorders. Front Psychol. 2018 Dec 11;9:2530. doi: 10.3389/fpsyg.2018.02530. eCollection 2018.
- Background: PubMed 38498048Rhiel S, Klay A, Keller U, van Hedel HJA, Ammann-Reiffer C. Comparing Walking-Related Everyday Life Tasks of Children with Gait Disorders in a Virtual Reality Setup With a Physical Setup: Cross-Sectional Noninferiority Study. JMIR Serious Games. 2024 Mar 18;12:e49550. doi: 10.2196/49550.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Kainat Subtain, MS-PPT principal investigator
Riphah International University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Standardized Walking Course Activities and Common Physical Activities in people with Autism Spectrum Disorder, run by Riphah International University at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 24 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact IMRAN AMJAD, PhD (9233224390125, imran.amjad@riphah.edu.pk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pediatric Berg's balance scale for balance assessment (time frame: Baseline, 4th week). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06943274, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Apr 2025.