NCT07799051

Brief Summary

This study compared the effects of group-based versus individual-based exercise programs on balance and coordination in children aged 3-12 years who were diagnosed with Autism Spectrum Disorder (ASD) Level 1. A total of 16 children were recruited and randomly allocated into two groups (n=8 each): Group A (individual-based) and Group B (group-based). Both groups received 40-minute exercise sessions, 3 days per week, for 6 weeks. Outcomes were assessed at baseline and after 6 weeks using the Pediatric Balance Scale (PBS) and neurological coordination tests (Finger-to-Nose, Heel-to-Shin, Past-Pointing).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
16

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2026

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

January 6, 2026

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 6, 2026

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 10, 2026

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

August 28, 2026

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 2, 2026

Completed
Last Updated

September 24, 2026

Status Verified

September 1, 2026

Enrollment Period

2 months

First QC Date

August 28, 2026

Last Update Submit

September 23, 2026

Conditions

Outcome Measures

Primary Outcomes (4)

  • Pediatric Balance Scale (PBS)

    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.

    Assessed at Baseline (Week 0) and Post-intervention (Week 6).

  • Finger-to-Nose Test

    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.

    Assessed at Baseline and Week 6

  • Heel-to-Shin Test

    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.

    Assessed at Baseline and Week 6

  • Past-Pointing Test

    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%).

    Assessed at Baseline and Week 6

Study Arms (2)

Group A - Individual-Based Exercise Program

EXPERIMENTAL

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.

Other: Individual based

Group B - Group-Based Exercise Program

ACTIVE COMPARATOR

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.

Other: Group Based Exercise

Interventions

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.

Group A - Individual-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.

Group B - Group-Based Exercise Program

Eligibility Criteria

Age3 Years - 12 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Diagnosed with Autism Spectrum Disorder (level one severity).
  • Age 3-12 years.
  • Ability to understand simple instructions.
  • No participation in previous physiotherapy balance programs.

You may not qualify if:

  • Co-existing intellectual disability or ADHD.
  • Visual impairments.
  • Chronic medical disorders affecting mobility or postural control.
  • Inability to participate consistently in sessions.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Primal Support Rehabilitation Centers and Special Education Institutions

Abbottābād, KPK, Pakistan

Location

MeSH Terms

Conditions

Autistic Disorder

Condition Hierarchy (Ancestors)

Autism Spectrum DisorderChild Development Disorders, PervasiveNeurodevelopmental DisordersMental Disorders

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 28, 2026

First Posted

September 2, 2026

Study Start

January 6, 2026

Primary Completion

March 6, 2026

Study Completion

June 10, 2026

Last Updated

September 24, 2026

Record last verified: 2026-09

Data Sharing

IPD Sharing
Will not share

Locations