- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06943274
SWOC Activities on Balance, Gait and Endurance in Children With Autism Spectrum Disorder
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.
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.
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: IMRAN AMJAD, PhD
- Phone Number: 9233224390125
- Email: imran.amjad@riphah.edu.pk
Study Contact Backup
- Name: Muhammad Asif Javed, MS-PT
- Phone Number: 923224209422
- Email: a.javed@riphah.edu.pk
Study Locations
-
-
Punjab
-
Lahore, Punjab, Pakistan, 54900
- Recruiting
- Rising Sun Institute
-
Contact:
- Muhammad Asif Javed, MS-PT(Neuro)
- Phone Number: 923224209422
- Email: a.javed@riphah.edu.pk
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- Severe physical impairment.
- Severe intellectual impairment.
- Comorbid conditions that could prevent participation.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Group A
For Group A Standardized Walking Obstacle Course Activities at least 2-3 times a week during a 4-week period.
|
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.
|
|
Active Comparator: Group B
For Group B other physical activities at least 2-3 times a week during a 4-week period.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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. |
Baseline, 4th week
|
|
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).
|
Baseline, 4th week
|
|
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.
|
Baseline, 4th week
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Kainat Subtain, MS-PPT, Riphah International University
Publications and helpful links
General 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.
- Rhiel 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- REC/RCR/AHS/25/Kainat Subtain
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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