- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06477224
Scooter Board Activities on Neck Control and Dysphagia in Children With Cerebral Palsy
Effects of Scooter Board Activities on Neck Control and Dysphagia in Children With Cerebral Palsy
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.
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Imran Amjad, PhD
- Phone Number: 03324390125
- Email: imran.amjad@riphah.edu.pk
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Scooter Board Activities
Participants in this arm receive treatment involving scooter board activities, which are hypothesized to improve neck control and alleviate symptoms of dysphagia.
|
Participants in this arm engage in scooter board activities designed to improve neck control and address dysphagia.
These activities include moving the scooter board in various directions using their hands or feet, maneuvering through obstacle courses, and engaging in playful tasks that require reaching or turning, which can enhance neck muscle strength and stability.
|
|
Experimental: Routine Physical Therapy
Participants in this arm receive conventional physical therapy treatments, which serve as the control group for comparing the effectiveness of the scooter board activities.
|
Participants in this arm receive traditional physical therapy interventions, which might include range-of-motion exercises, muscle strengthening, stretching exercises, and postural control activities.
These exercises are aimed at improving overall motor function, with a focus on neck stability and control.
Standard physical therapy equipment such as therapy balls, balance boards, and resistance bands may also be used.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Gross Motor Function Measure (GMFM)
Time Frame: 6 weeks
|
The GMFM will help quantify the extent of improvement in neck control among participants, determining the effectiveness of the scooter board activities compared to routine physical therapy.
This measure is crucial as effective neck control is fundamental for posture, movement, and various daily activities, thereby impacting the quality of life and functional independence of children with cerebral palsy.
Total the scores from each category.
The maximum possible score will depend on the number of categories included and the scoring range for each.
A higher overall score generally indicates better oral motor functioning.
Low scores in specific areas may indicate the need for targeted intervention.
|
6 weeks
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Arnab Altaf, PP-DPT, Riphah International University Lahore
Publications and helpful links
General Publications
- 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. Erratum In: Dev Med Child Neurol. 2016 Mar;58(3):316.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
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
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- REC/RCR&AHS/23/0787
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
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Cerebral Palsy (CP)
-
IRCCS Fondazione Stella MarisUniversity of Siena, ItalyRecruitingCerebral Palsy (CP) | Motor Imagery | CP (Cerebral Palsy) | Action ObservationItaly
-
Ibadat International University, IslamabadRecruitingCerebral Palsy (CP) | Athetoid CPPakistan
-
Cairo UniversityCompletedCerebral Palsy (CP) | Unilateral Cerebral PalsyEgypt
-
Holland Bloorview Kids Rehabilitation HospitalCanadian Institutes of Health Research (CIHR)RecruitingCerebral Palsy (CP) | Hemiplegic Cerebral PalsyCanada
-
University of California, San FranciscoNot yet recruitingCerebral Palsy | Cerebral Palsy (CP) | Infant | Cerebral Palsy InfantileUnited States
-
International Clinic of Rehabilitation, UkraineElita Rehabilitation CenterRecruitingCerebral Palsy (CP)Ukraine
-
University of ThessalyNot yet recruiting
-
Centre Médico-Chirurgical de Réadaptation des Massues...Recruiting
-
Baylor UniversityEunice Kennedy Shriver National Institute of Child Health and Human Development...RecruitingCerebral Palsy (CP)United States
-
Istanbul University - CerrahpasaActive, not recruitingCerebral Palsy (CP)Turkey (Türkiye)
Clinical Trials on Scooter Board Activities
-
Badr UniversityEnrolling by invitation
-
National Taiwan University HospitalMinistry of Science and Technology, Taiwan; National Taiwan University; National...CompletedCognitive TrainingTaiwan
-
National Taiwan University HospitalRecruitingPromoting Active Inference of Healthy Older Adults With Language ActivityTaiwan
-
VA Office of Research and DevelopmentTerminated
-
Geisinger ClinicCompletedRadiation Exposure to OperatorUnited States
-
Ontario Clinical Oncology Group (OCOG)U.S. Army Medical Research and Development Command; Supportive Cancer Care...Completed
-
Dana-Farber Cancer InstituteBrigham and Women's HospitalCompleted
-
Louise FarrerWithdrawn
-
Riphah International UniversityCompletedGeriatric PopulationPakistan