Cerebral Palsy (CP)NCT06477224
Scooter Board Activities on Neck Control and Dysphagia in Children With Cerebral Palsy
A study testing Scooter Board Activities and Routine Physical Therapy in people with Cerebral Palsy (CP), run by Riphah International University.
Trial 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… Read more about this study
- Who is it for?
- Ages 6 to 10 years
- Conditions the study is for
- Cerebral Palsy (CP)
- What is being tested?
- Scooter Board Activities and Routine Physical Therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- No sites listed yet
- Study dates
- Jun 2024to 25 Jul 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 10 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: 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.
Read the 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.
- Conditions
- Cerebral Palsy (CP)
- Being tested
- Scooter Board Activities, Routine Physical Therapy
- Keywords
- Cerebral Palsy (CP), Dysphagia, Neck Muscles, Scooter Board Activities, Pediatric Physical Therapy, Motor Function
- Medical subject headings
- Cerebral Palsy, Deglutition Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Scooter Board ActivitiesOther
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.
Routine Physical TherapyOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Scooter Board Activities | Experimental | Participants in this arm receive treatment involving scooter board activities, which are hypothesized to improve neck control and alleviate symptoms of dysphagia. Receives: Other: Scooter Board Activities |
| Routine Physical Therapy | Experimental | Participants in this arm receive conventional physical therapy treatments, which serve as the control group for comparing the effectiveness of the scooter board activities. Receives: Other: Routine Physical Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gross Motor Function Measure (GMFM)
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.
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2024
- Study startJun 2024 (estimated)
- Primary completion20 Jul 2024 (estimated)
- Study completion25 Jul 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Cerebral Palsy (CP)Studies of the same condition, open and under way.
- More trials run by Riphah International UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 22 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Arnab Altaf, PP-DPT, Principal investigator, Riphah International University Lahore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06477224
- Sponsor's protocol ID
- REC/RCR&AHS/23/0787
- Status last verified
- Jun 2024
- First submitted
- 11 Jun 2024
- Last updated
- 27 Jun 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 23346889Graham 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.
PubMed 27188686Benfer 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.
PubMed 29167377
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Scooter Board Activities on Neck Control and Dysphagia in Children With Cerebral Palsy
- ClinicalTrials.gov ID
- NCT06477224
- Acronym / sponsor ID
- REC/RCR&AHS/23/0787
- Conditions
- Cerebral Palsy (CP)
- Keywords
- Cerebral Palsy (CP), Dysphagia, Neck Muscles, Scooter Board Activities, Pediatric Physical Therapy, Motor Function
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 22 participants (estimated)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- Jun 2024 (estimated)
- Primary completion
- 20 Jul 2024 (estimated)
- Study completion
- 25 Jul 2024 (estimated)
- First posted
- 27 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Scooter Board Activities | Experimental | Other: Scooter Board ActivitiesParticipants in this arm receive treatment involving scooter board activities, which are hypothesized to improve neck control and alleviate symptoms of dysphagia. |
| Routine Physical Therapy | Experimental | Other: Routine Physical TherapyParticipants in this arm receive conventional physical therapy treatments, which serve as the control group for comparing the effectiveness of the scooter board activities. |
Who may qualify
- Ages
- 6 to 10 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Scooter Board ActivitiesParticipants 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. | Other | Scooter Board Activities |
| Routine Physical TherapyParticipants 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. | Other | Routine Physical Therapy |
Primary outcome
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jun 2024.
- Background: PubMed 23346889Oskoui 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.
- Background: PubMed 27188686Graham 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.
- Background: PubMed 29167377Benfer 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.
- Individual participant dataSharing planned: No
Related trials for Cerebral Palsy (CP)
Recruiting
Additional Effects on tDCS With AOT on Lower Limb Functions on Children With Diplegic CP
Diplegic Cerebral Palsy
Recruiting
Comparison of Vestibular Stimulation and Core Stability Training on Sitting Balance in Hypotonic CP
Hypotonic Cerebral Palsy
Not yet recruiting
Video-based Visual Feedback Combined With Task-oriented Physiotherapy Among Cerebral Palsy
Cerebral Palsy (CP)
RecruitingObservational study
Turkish Translation, Cross-Cultural Adaptation, Validity, and Reliability of the ABILHAND-Kids Young CP Scale
Cerebral Palsy
Active, not recruiting
Local Vibration for Drooling in Children With Cerebral Palsy
Cerebral Palsy (CP)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Arnab Altaf, PP-DPT principal investigator
Riphah International University Lahore
Questions about this trial
What is this clinical trial studying?
A study testing Scooter Board Activities and Routine Physical Therapy in people with Cerebral Palsy (CP), run by Riphah International University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 27 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Imran Amjad, Phd (03324390125, imran.amjad@riphah.edu.pk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Gross Motor Function Measure (GMFM) (time frame: 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06477224, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jun 2024.