Cerebral PalsyNCT06739538
Effects Of Bobath Exercises Combined With Gasotransmitter On Spastic Diplegic CP
A study testing Bobath exercises and Gasotransmitters in people with Cerebral Palsy, run by Superior University at 1 site in Pakistan.
Trial summary
This study examines the effects of combining Bo bath neurodevelopmental exercises with gasotransmitter in children with spastic diplegic cerebral palsy, a condition marked by muscle stiffness and coordination challenges in the legs. Read more about this study
- Who is it for?
- Ages 6 to 18 years
- Conditions the study is for
- Cerebral Palsy
- What is being tested?
- Bobath exercises and Gasotransmitters
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 47 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Mar 2024to 28 Feb 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- A Confirmed diagnosis of spastic diplegic cerebral palsy
- Participants aged 6 to 18 years.
- Moderate to severe spasticity in the lower limbs, as measured by the Modified Ashworth Scale.
- Ability to follow simple instructions and participate in the stretching exercises.
- Written informed consent obtained from the participant's legal guardian or the participant if of legal consenting age.
- No significant changes in medication or therapy for cerebral palsy in the three months prior to the study.
Who cannot join
- Presence of other neurological conditions apart from spastic diplegic cerebral palsy.
- History of major orthopaedic surgery in the past year or planned surgery during the study period.
- Receipt of botulinum toxin injections in the lower limbs within the last six months.
- Severe joint contractures that limit the range of motion necessary for the stretching exercises.
- Any medical condition that contraindicates participation in the study, such as uncontrolled epilepsy, severe cardiovascular disorders, or acute infections.
- Inability or unwillingness to comply with the study protocol and scheduled visits.
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
Ilaj Hospital
Chak One Hundred Seventy-five Nine Left, Punjab Province
About this study
This study examines the effects of combining Bo bath neurodevelopmental exercises with gasotransmitter in children with spastic diplegic cerebral palsy, a condition marked by muscle stiffness and coordination challenges in the legs.
Read the detailed description
The primary objective is to enhance motor learning by reinforcing weak movement patterns while reducing excessive muscle activity. Additionally, this combination aims to improve postural control, movement coordination, and overall functional abilities.The randomized controlled trial includes 47 children aged 6-18, divided into three groups: one receiving only Bo bath exercises, another receiving gasotransmitter alone, and a third receiving both interventions. Baseline assessments were conducted, and ethical approval along with informed consent was obtained. The interventions target spasticity reduction and gross motor improvement, with outcomes measured using the Gross Motor Function Classification System (GMFCS) for motor skills and the Modified Ashworth Scale for spasticity. Findings suggest that combining Bo bath therapy with gasotransmitters effectively reduces spasticity, enhances motor control, and supports activities of daily living, highlighting its potential as an effective therapeutic approach.
- Conditions
- Cerebral Palsy
- Being tested
- Bobath exercises, Gasotransmitters
- Medical subject headings
- Cerebral Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bobath exercisesDiagnostic test
Bobath concept, are therapeutic techniques designed to improve motor control and function in individuals with neurological conditions, particularly those with cerebral palsy. These exercises focus on facilitating normal movement patterns, enhancing postural stability, and reducing muscle spasticity. The approach emphasizes individualized treatment, utilizing hands-on techniques to promote movement awareness and encourage the development of functional skills. By reinforcing weak movements and inhibiting overactive ones, Bobath exercises aim to enhance overall motor abilities and improve the quality of life for affected individuals.
GasotransmittersCombination product
such as nitric oxide (NO), carbon monoxide (CO), and hydrogen sulfide (H₂S), are small gaseous signaling molecules that play key roles in various physiological functions, including the regulation of muscle tone and neuroinflammation. In the context of spastic diplegic cerebral palsy (CP), gasotransmitters may help reduce spasticity and pain. Gasotransmitters help reduce spasticity and pain in children with spastic diplegic cerebral palsy through multiple mechanisms: Muscle relaxation and improved blood flow reduce muscle tightness, Anti-inflammatory and neuroprotective properties help minimize the damage that exacerbates spasticity.They also modulate pain pathways, both centrally and peripherally, reducing pain perception.
| Study group | Role | What they receive |
|---|---|---|
| Bobath exercises | Experimental | Not described Receives: Diagnostic Test: Bobath exercises |
| Gasotransmitters | Active comparator | Not described Receives: Combination Product: Gasotransmitters |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gross Motor Function Classification System (GMFCS)
The Gross Motor Function Classification System (GMFCS) is a five-level clinical classification tool that categorizes the gross motor function of children and young people with cerebral palsy (CP) based on their self-initiated movement abilities, particularly sitting, walking, and mobility. The GMFCS is used to understand and predict the mobility needs and functional capabilities of individuals, aiding in treatment planning, goal setting, and tracking functional changes over time.
Measured: 12 Months
Manual Muscle Testing Manual Muscle Testing (MMT)
It is a clinical assessment technique used to evaluate and grade the strength of individual muscles or muscle groups based on their ability to resist force. In MMT, the clinician applies pressure to a muscle while the patient resists, allowing for a standardized rating, typically on a scale from 0 to 5:
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Dec 2024
- Study start1 Mar 2024
- Primary completion1 Sep 2024
- Study completion28 Feb 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cerebral PalsyStudies of the same condition, open and under way.
- More trials run by Superior 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 47 participants (actual)
Sponsor and investigators
- Lead sponsor
- Superior University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Muhammad Naveed Babur, Superior University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06739538
- Sponsor's protocol ID
- MSRSW/Batch-Fall22/752
- Status last verified
- Dec 2024
- First submitted
- 13 Dec 2024
- Last updated
- 18 Dec 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects Of Bobath Exercises Combined With Gasotransmitter On Spastic Diplegic CP
- ClinicalTrials.gov ID
- NCT06739538
- Acronym / sponsor ID
- MSRSW/Batch-Fall22/752
- Conditions
- Cerebral Palsy
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 47 participants (actual)
- Lead sponsor
- Superior UniversityUniversity, hospital or other
- Study start
- 1 Mar 2024 (actual)
- Primary completion
- 1 Sep 2024 (actual)
- Study completion
- 28 Feb 2025 (estimated)
- First posted
- 18 Dec 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 examines the effects of combining Bo bath neurodevelopmental exercises with gasotransmitter in children with spastic diplegic cerebral palsy, a condition marked by muscle stiffness and coordination challenges in the legs.
Detailed description
The primary objective is to enhance motor learning by reinforcing weak movement patterns while reducing excessive muscle activity. Additionally, this combination aims to improve postural control, movement coordination, and overall functional abilities.The randomized controlled trial includes 47 children aged 6-18, divided into three groups: one receiving only Bo bath exercises, another receiving gasotransmitter alone, and a third receiving both interventions. Baseline assessments were conducted, and ethical approval along with informed consent was obtained. The interventions target spasticity reduction and gross motor improvement, with outcomes measured using the Gross Motor Function Classification System (GMFCS) for motor skills and the Modified Ashworth Scale for spasticity. Findings suggest that combining Bo bath therapy with gasotransmitters effectively reduces spasticity, enhances motor control, and supports activities of daily living, highlighting its potential as an effective therapeutic approach.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Bobath exercises | Experimental | Diagnostic Test: Bobath exercises |
| Gasotransmitters | Active comparator | Combination Product: Gasotransmitters |
Who may qualify
- Ages
- 6 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (6 listed)
- A Confirmed diagnosis of spastic diplegic cerebral palsy
- Participants aged 6 to 18 years.
- Moderate to severe spasticity in the lower limbs, as measured by the Modified Ashworth Scale.
- Ability to follow simple instructions and participate in the stretching exercises.
- Written informed consent obtained from the participant's legal guardian or the participant if of legal consenting age.
Key exclusion criteria (6 listed)
- Presence of other neurological conditions apart from spastic diplegic cerebral palsy.
- History of major orthopaedic surgery in the past year or planned surgery during the study period.
- Receipt of botulinum toxin injections in the lower limbs within the last six months.
- Severe joint contractures that limit the range of motion necessary for the stretching exercises.
- Any medical condition that contraindicates participation in the study, such as uncontrolled epilepsy, severe cardiovascular disorders, or acute infections.
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 |
|---|---|---|
| Bobath exercisesBobath concept, are therapeutic techniques designed to improve motor control and function in individuals with neurological conditions, particularly those with cerebral palsy. These exercises focus on facilitating normal movement patterns, enhancing postural stability, and reducing muscle spasticity. The approach emphasizes individualized treatment, utilizing hands-on techniques to promote movement awareness and encourage the development of functional skills. By reinforcing weak movements and inhibiting overactive ones, Bobath exercises aim to enhance overall motor abilities and improve the quality of life for affected individuals. | Diagnostic test | Bobath exercises |
| Gasotransmitterssuch as nitric oxide (NO), carbon monoxide (CO), and hydrogen sulfide (H₂S), are small gaseous signaling molecules that play key roles in various physiological functions, including the regulation of muscle tone and neuroinflammation. In the context of spastic diplegic cerebral palsy (CP), gasotransmitters may help reduce spasticity and pain. Gasotransmitters help reduce spasticity and pain in children with spastic diplegic cerebral palsy through multiple mechanisms: Muscle relaxation and improved blood flow reduce muscle tightness, Anti-inflammatory and neuroprotective properties help minimize the damage that exacerbates spasticity.They also modulate pain pathways, both centrally and peripherally, reducing pain perception. | Combination product | Gasotransmitters |
Primary outcome
Gross Motor Function Classification System (GMFCS)
Time frame: 12 Months
The Gross Motor Function Classification System (GMFCS) is a five-level clinical classification tool that categorizes the gross motor function of children and young people with cerebral palsy (CP) based on their self-initiated movement abilities, particularly sitting, walking, and mobility. The GMFCS is used to understand and predict the mobility needs and functional capabilities of individuals, aiding in treatment planning, goal setting, and tracking functional changes over time.
Manual Muscle Testing Manual Muscle Testing (MMT)
Time frame: 12 months
It is a clinical assessment technique used to evaluate and grade the strength of individual muscles or muscle groups based on their ability to resist force. In MMT, the clinician applies pressure to a muscle while the patient resists, allowing for a standardized rating, typically on a scale from 0 to 5:
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Dec 2024.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bobath exercises and Gasotransmitters in people with Cerebral Palsy, run by Superior University at 1 site in Pakistan.
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 6 inclusion and 6 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: under way, not looking for participants, as of the sponsor's last update on 18 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Gross Motor Function Classification System (GMFCS) (time frame: 12 Months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 18 Dec 2024.