跳至主要内容
临床试验/NCT06943274
NCT06943274招募中不适用

Effects of Standardized Walking Obstacle Course (SWOC) Activities on Balance, Gait and Endurance in Children With Autism Spectrum Disorder

Riphah International University1 个研究点 分布在 1 个国家目标入组 44 人开始时间: 2025年4月15日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
44
试验地点
1
主要终点
Pediatric Berg's balance scale for balance assessment

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
Single (Participant)

盲法说明

The participants were blinded throughout the session but therapist and assessor were not be so it was a single blinded session.

入排标准

年龄范围
8 Years 至 12 Years(Child)
性别
All
接受健康志愿者
否

入选标准

  • •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.

排除标准

  • •Severe physical impairment.
  • •Severe intellectual impairment.
  • •Comorbid conditions that could prevent participation.

研究组 & 干预措施

Group A

Experimental

For Group A Standardized Walking Obstacle Course Activities at least 2-3 times a week during a 4-week period.

干预措施: Standardized Walking Course Activities (Other)

Group B

Active Comparator

For Group B other physical activities at least 2-3 times a week during a 4-week period.

干预措施: Common Physical Activities (Other)

结局指标

主要结局

Pediatric Berg's balance scale for balance assessment

时间窗: 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

时间窗: 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

时间窗: 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.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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