NCT05067361

Brief Summary

Autism spectrum disorder (ASD) is a neurodevelopmental disorder manifesting stereotypic behaviors and problem in communication and social interaction. Different physical therapy interventions like aerobics help to improve recurrent behaviors and task performance of autistic children. This study was focused to see the effect of jogging on the stereotypic behaviors and task performance of autistic children. A single blinded randomized study was conducted on 38 autistic children, randomly allocated to two groups, performing jogging and ball exercises. Repetitive Behavior Scale-revised(RBS-R) and Jebsen Hand Function Test (JHFT) was used for assessment. Exercise was performed for 3 weeks and 4 sessions per week.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
38

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2020

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 3, 2020

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 8, 2020

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 26, 2020

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

September 23, 2021

Completed
12 days until next milestone

First Posted

Study publicly available on registry

October 5, 2021

Completed
Last Updated

October 5, 2021

Status Verified

October 1, 2021

Enrollment Period

5 months

First QC Date

September 23, 2021

Last Update Submit

October 4, 2021

Conditions

Keywords

Autism spectrum disorderPhysical therapyStereotypic behaviorsASDRepetitive behaviorsAerobic exercisesJoggingBall exercises.

Outcome Measures

Primary Outcomes (1)

  • Repetitive behavior scale revised (RBS-R)

    RBS-R was used to assess the stereotypic behaviors of autistic children. It is 43 items questionnaire that is placed under six subscales. The sub-scales are Stereotyped Behavior Subscale Self-Injurious Behavior Subscale Compulsive Behavior Subscale Ritualistic Behavior Subscale Sameness Behavior Subscale Restricted Behavior Subscale Each subscale has different characteristics, which are classified from 0 to 3 (behavior is severe). Moreover, each behavior is also rated that how much this behavior occurs, cause interruption in activity and how much a child become agitated when he was interrupted. Global score rating was used by calculating the scores of all the six subscales and total score was given in range of 1 to 100.

    3 weeks

Secondary Outcomes (1)

  • Jebsen Hand Function Test (JHFT)

    3 weeks

Study Arms (2)

Experimental Group

EXPERIMENTAL
Procedure: Aerobic ExerciseProcedure: Ball Exercises

Active control Group

ACTIVE COMPARATOR
Procedure: Ball Exercises

Interventions

Jogging was performed for 20 minutes. Jogging was performed by experimental group for 3 weeks and 4 sessions per week.

Experimental Group

Ball exercises like stability ball roll, stability ball hug, stability ball catching, ball throwing and ball tapping exercises were for 10 minutes. Ball exercises was performed by both groups for 3 weeks and 4 times per week .

Active control GroupExperimental Group

Eligibility Criteria

Age6 Years - 20 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Diagnosed children of autism spectrum disorder (ASD) by experts
  • Have recognized stereotypic behaviors
  • Age 6 to 20 years
  • Independent to walk
  • Both genders
  • Parent and teachers willing to give consent

You may not qualify if:

  • Unable to understand commands
  • Have co-morbidities like schizophrenia or ADHD
  • Having respiratory or cardiovascular problems
  • Severe ASD
  • Lower limb injury and disability

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Faisalabad

Faisalābad, Punjab Province, 38000, Pakistan

Location

MeSH Terms

Conditions

Autism Spectrum DisorderStereotypic Movement Disorder

Interventions

Exercise

Condition Hierarchy (Ancestors)

Child Development Disorders, PervasiveNeurodevelopmental DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Dr Sidra Majeed;PT, MSPP

    University of Faisalabad

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Physical Therapist

Study Record Dates

First Submitted

September 23, 2021

First Posted

October 5, 2021

Study Start

March 3, 2020

Primary Completion

August 8, 2020

Study Completion

October 26, 2020

Last Updated

October 5, 2021

Record last verified: 2021-10

Data Sharing

IPD Sharing
Will not share

Locations