Clinical trial NCT06739538: Effects Of Bobath Exercises Combined With Gasotransmitter On Spastic Diplegic CP
Official title: Effects Of Bobath Exercises Combined With Gasotransmitter On Spastic Diplegic CP
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Cerebral Palsy
Lead sponsor: Superior University
Sponsor class: OTHER
First posted: 2024-12-18
Enrollment: 47
Sex: ALL
Minimum age (years): 6
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief 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.

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.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Gross Motor Function Classification System (GMFCS)
timeFrame: 12 Months
measure: Manual Muscle Testing Manual Muscle Testing (MMT)
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Gujrānwāla
country: Pakistan
facility: Ilaj Hospital
state: Punjab
Study officials:
References: