- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07799051
Examining the Effects of Group Versus Individual Based Exercise Program on Balance and Coordination in Children With Autism
Examining the Effects of Group Versus Individual-Based Exercise Programs on Balance and Coordination in Children With Autism: A Randomized Controlled Trial
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Background: Autism Spectrum Disorder (ASD) is a complex neurodevelopmental condition affecting motor function, including balance and coordination. Physical activity interventions showed promise in improving motor outcomes, but comparative evidence between group-based and individual-based formats was limited.
Study Design: Randomized Controlled Trial with parallel assignment. Participants: 16 children (aged 3-12 years) with ASD Level 1 severity were recruited from rehabilitation centers and special education institutions in Islamabad, Pakistan, using purposive sampling and random allocation via lottery method.
Interventions: Group A (Individual-Based): Each child received a personalized 40-minute physiotherapy exercise session including warm-up (movement to music, trampoline jumping, stair climbing), balance and coordination exercises (single-leg stance, animal walks, wobble board, ball games, tug of war, obstacle course), and cool-down (bubble blowing, block building). Sessions were delivered 3 times per week for 6 weeks. Group B (Group-Based): The same exercise protocol was delivered in group, incorporating peer interaction, social modeling, and group dynamics.
Outcome Measures: Pediatric Balance Scale (PBS; score 0-56) and neurological coordination tests (Finger-to-Nose, Heel-to-Shin, Past-Pointing) were administered pre- and post-intervention.
Data Analysis: Data were analyzed using SPSS v21. Normality was assessed and tests were applied accordingly.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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KPK
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Abbottābād, KPK, Pakistan
- Primal Support Rehabilitation Centers and Special Education Institutions
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
Description
Inclusion Criteria:
Diagnosed with Autism Spectrum Disorder (level one severity). Age 3-12 years. Ability to understand simple instructions. No participation in previous physiotherapy balance programs.
Exclusion Criteria:
Co-existing intellectual disability or ADHD. Visual impairments. Chronic medical disorders affecting mobility or postural control. Inability to participate consistently in sessions.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Group A - Individual-Based Exercise Program
Individual-Based Physiotherapy Exercise Program (40 min/session, 3×/week, 6 weeks): Warm-up, balance and coordination exercises (single-leg stance, animal walks, wobble board, ball games, obstacle course), cool-down activities.
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Individual-Based Physiotherapy Exercise Program (40 min/session, 3×/week, 6 weeks): Warm-up, balance and coordination exercises (single-leg stance, animal walks, wobble board, ball games, obstacle course), cool-down activities.
|
|
Active Comparator: Group B - Group-Based Exercise Program
Group-Based Physiotherapy Exercise Program (40 min/session, 3×/week, 6 weeks): Same protocol as Group A but delivered in group, incorporating peer interaction and social modeling.
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Group-Based Physiotherapy Exercise Program (40 min/session, 3×/week, 6 weeks): Same protocol as Group A but delivered in group, incorporating peer interaction and social modeling.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Pediatric Balance Scale (PBS)
Time Frame: Assessed at Baseline (Week 0) and Post-intervention (Week 6).
|
It is a comprehensive and effective scale evaluating the balance in the following three dimensions: static balance, anticipatory balance, and functional movement transitions.
The scale comprises 14 items including sitting balance, standing balance, sitting to standing/standing to sitting, transfers, stepping, reaching forward with outstretched arm, reaching the floor, turning, and placing foot on stool items.
Each item ranked from 0 to 4. 0 shows inability to perform the instruction, while 4 shows the ability to perform without any difficulty.
Maximum total score is 56.
The intraobserver agreement of the PBS total score was high, perfectly (ICC=0.927).(15,
16) PBS can be considered a simple, valid scale for examining functional balance capacity in children with neurological disorders.
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Assessed at Baseline (Week 0) and Post-intervention (Week 6).
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Finger-to-Nose Test
Time Frame: Assessed at Baseline and Week 6
|
A widely used neurological test for evaluating cerebellar function and upper limb coordination, the finger-to-nose test involves the patient alternately touching the examiner's finger and their nose in a smooth, controlled manner.
Its reliability is generally moderate to good.
Its validity is thought to be good for detecting gross cerebellar dysfunction, coordination, intention tremor, and dysmetria.
Sensitivity roughly 60-85% and specificity around 70-90, while its reliability is usually moderate to good, with inter-rater reliability coefficients (ICC or kappa) commonly reported in the range of 0.60-0.85.
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Assessed at Baseline and Week 6
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Heel-to-Shin Test
Time Frame: Assessed at Baseline and Week 6
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The heel-to-shin test is a neurological examination used to evaluate lower-limb coordination and cerebellar function.
The patient is asked to place the heel of one foot on the opposite knee and smoothly slide it down the shin to the ankle.
Normal performance is smooth and accurate; abnormal findings, such as irregular movement, side-to-side wavering, inability to maintain contact, or intention tremor, suggest cerebellar dysfunction, sensory ataxia.
Studies report sensitivity ranging approximately from 65-90% and specificity around 70-95% for detecting significant cerebellar dysfunction, depending on standardization and patient population, while its reliability is generally moderate to good, with reported inter-rater and intra-rater reliability coefficients (ICC or kappa) typically between 0.60 and 0.85.
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Assessed at Baseline and Week 6
|
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Past-Pointing Test
Time Frame: Assessed at Baseline and Week 6
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When a person consistently overshoots or undershoots a target during voluntary, goal-directed movements, it is a sign of impaired cerebellar coordination.
It reflects defective error correction and timing of agonist-antagonist muscle activity normally regulated by the cerebellum, leading to dysmetria.
It becomes more pronounced when visual guidance is removed, which worsens primarily with eyes closed, multiple sclerosis, and autism.
Sensitivity (~60-80%) and good specificity (~70-90%).
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Assessed at Baseline and Week 6
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Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
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
Additional Relevant MeSH Terms
Other Study ID Numbers
- IIUI/RERC/ADT/2026/01/213
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
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