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
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Descrição detalhada
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.
Tipo de estudo
Inscrição (Real)
Estágio
- Não aplicável
Contactos e Locais
Locais de estudo
-
-
KPK
-
Abbottābād, KPK, Paquistão
- Primal Support Rehabilitation Centers and Special Education Institutions
-
-
Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
- Filho
Aceita Voluntários Saudáveis
Descrição
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.
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
|
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.
|
|
Comparador Ativo: 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.
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Pediatric Balance Scale (PBS)
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
|
Colaboradores e Investigadores
Patrocinador
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Real)
Conclusão Primária (Real)
Conclusão do estudo (Real)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- IIUI/RERC/ADT/2026/01/213
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
Informações sobre medicamentos e dispositivos, documentos de estudo
Estuda um medicamento regulamentado pela FDA dos EUA
Estuda um produto de dispositivo regulamentado pela FDA dos EUA
Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .