Clinical trial NCT06477224: Scooter Board Activities on Neck Control and Dysphagia in Children With Cerebral Palsy
Official title: Effects of Scooter Board Activities on Neck Control and Dysphagia in Children With Cerebral Palsy
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Cerebral Palsy (CP)
Keywords: Cerebral Palsy (CP)
Dysphagia
Neck Muscles
Scooter Board Activities
Pediatric Physical Therapy
Motor Function
Lead sponsor: Riphah International University
Sponsor class: OTHER
First posted: 2024-06-27
Enrollment: 22
Sex: ALL
Minimum age (years): 6
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: It will be Randomized control trial in which Purposive sampling technique will be used. Two groups of 6-10 age will be formed in which participants will be randomly divided. Group A will only receives the experimental treatment, which in this case involves scooter board activities designed to improve neck control and potentially alleviate dysphagia symptoms and group B will receives conventional care, which typically involves standard physical therapy practices, serving as a baseline to evaluate the effects of the experimental treatment.
Primary purpose: TREATMENT

Brief summary: This study is a randomized control trial exploring the therapeutic effects of scooter board activities on neck control and dysphagia in children with cerebral palsy (CP). Part of a Master of Science in Physical Therapy program, the research focuses on innovative uses of scooter boards-flat, wheeled platforms that allow children to propel themselves while lying or sitting. This activity is hypothesized to improve neck stability and swallowing functions, which are crucial for posture, movement, and reducing health risks such as malnutrition and aspiration pneumonia.

The trial will employ validated tools like the Eating and Drinking Ability Classification System (EDACS), Schedule for Oral Motor Assessment (SOMA), and Gross Motor Function Measure (GMFM) to assess changes in participants. Conducted over six months at facilities including Rehab Care, Rich Care, and Royal College Hospital, it will involve 22 children, aged 6-10, diagnosed with spastic CP and exhibiting symptoms of dysphagia.

The outcomes of this research could revolutionize therapeutic practices by providing a playful, engaging approach to therapy that enhances both motor and social skills.

Detailed description: This randomized control trial investigates the effects of scooter board activities on neck control and dysphagia in children with cerebral palsy (CP), focusing on a group of children aged 6 to 10 years diagnosed with spastic CP. The core hypothesis is that scooter board activities, which involve using a flat, wheeled platform where children can propel themselves using their limbs, can improve neck stability and swallowing functions-critical areas that affect posture, movement, and health risks such as malnutrition and aspiration pneumonia.

The study is structured as a controlled experiment with two groups: one receiving the innovative scooter board treatment and the other undergoing traditional physical therapy as a control. The effectiveness of these interventions will be measured using three validated assessment tools:

Eating and Drinking Ability Classification System (EDACS) - This tool classifies the eating and drinking abilities of individuals with CP, focusing on the safety, efficiency, and level of assistance required.

Schedule for Oral Motor Assessment (SOMA) - This assesses oral motor function, evaluating the ability to use lips, tongue, and jaw, which are crucial for eating and communication.

Gross Motor Function Measure (GMFM) - Used to observe changes in gross motor function, it helps quantify improvements in motor skills that may relate directly to the therapies administered.

The research will take place over six months, following the approval from an advanced research committee and institutional review board. Data will be collected from multiple locations, including Rehab Care, Rich Care, and Royal College Hospital. A total of 22 children will be randomly assigned to either the intervention group or the control group.

This trial aims to not only validate the effectiveness of scooter board activities in improving neck control and reducing dysphagia symptoms but also to enhance the quality of life for children with CP by integrating play into therapeutic practices. The potential for significant findings could lead to innovative, engaging therapy options that align with children's natural tendencies towards play, thereby enhancing therapy adherence and effectiveness.

Eligibility criteria: Inclusion Criteria:

* Age: Participants must be between 6 to 10 years old.
* Diagnosis: Must be diagnosed with spastic cerebral palsy.
* Symptoms of Dysphagia: Must exhibit symptoms of dysphagia, as confirmed by clinical assessment.
* Ability to Follow Instructions: Must be able to follow simple instructions to participate in the therapeutic activities effectively.

Exclusion Criteria:

* Severe Cognitive or Sensory Impairments: Children with severe cognitive or sensory impairments that prevent participation in the intervention are excluded. This is to ensure that participants can engage effectively in the therapy sessions and follow the instructions required for the scooter board activities and assessments.
* Previous Neck Muscle Strengthening Interventions: Children who have previously undergone specific interventions aimed at strengthening neck muscles are excluded to maintain a baseline uniformity among participants. This criterion helps in assessing the pure effect of the scooter board activities without interference from prior similar treatments.

Primary outcomes:
measure: Gross Motor Function Measure (GMFM)
timeFrame: 6 weeks
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Riphah International University Lahore
name: Arnab Altaf, PP-DPT
role: PRINCIPAL_INVESTIGATOR
References:
citation: Oskoui M, Coutinho F, Dykeman J, Jette N, Pringsheim T. An update on the prevalence of cerebral palsy: a systematic review and meta-analysis. Dev Med Child Neurol. 2013 Jun;55(6):509-19. doi: 10.1111/dmcn.12080. Epub 2013 Jan 24.
citation: Graham HK, Rosenbaum P, Paneth N, Dan B, Lin JP, Damiano DL, Becher JG, Gaebler-Spira D, Colver A, Reddihough DS, Crompton KE, Lieber RL. Cerebral palsy. Nat Rev Dis Primers. 2016 Jan 7;2:15082. doi: 10.1038/nrdp.2015.82.
citation: Benfer KA, Weir KA, Bell KL, Ware RS, Davies PSW, Boyd RN. Oropharyngeal Dysphagia and Cerebral Palsy. Pediatrics. 2017 Dec;140(6):e20170731. doi: 10.1542/peds.2017-0731.