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
Studienübersicht
Status
Bedingungen
Intervention / Behandlung
Detaillierte Beschreibung
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.
Studientyp
Einschreibung (Tatsächlich)
Phase
- Unzutreffend
Kontakte und Standorte
Studienorte
-
-
KPK
-
Abbottābād, KPK, Pakistan
- Primal Support Rehabilitation Centers and Special Education Institutions
-
-
Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
- Kind
Akzeptiert gesunde Freiwillige
Beschreibung
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.
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Behandlung
- Zuteilung: Zufällig
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Keine (Offenes Etikett)
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
|---|---|
|
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.
|
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.
|
|
Aktiver Komparator: 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.
|
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.
|
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Pediatric Balance Scale (PBS)
Zeitfenster: 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.
|
Assessed at Baseline (Week 0) and Post-intervention (Week 6).
|
|
Finger-to-Nose Test
Zeitfenster: 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.
|
Assessed at Baseline and Week 6
|
|
Heel-to-Shin Test
Zeitfenster: Assessed at Baseline and Week 6
|
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
Zeitfenster: Assessed at Baseline and Week 6
|
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
|
Mitarbeiter und Ermittler
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn (Tatsächlich)
Primärer Abschluss (Tatsächlich)
Studienabschluss (Tatsächlich)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Tatsächlich)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- IIUI/RERC/ADT/2026/01/213
Plan für individuelle Teilnehmerdaten (IPD)
Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?
Arzneimittel- und Geräteinformationen, Studienunterlagen
Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt
Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .