Effects Of Bobath Exercises Combined With Gasotransmitter On Spastic Diplegic CP

NCT ID: NCT06739538

Last Updated: 2024-12-18

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 47 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-03-01
• Study Completion Date: 2025-02-28

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.

Conditions

Cerebral Palsy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

Bobath exercises

Group Type: EXPERIMENTAL

Bobath exercises

Intervention Type: DIAGNOSTIC_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.

Gasotransmitters

Group Type: ACTIVE_COMPARATOR

Gasotransmitters

Intervention Type: COMBINATION_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.

Interventions

Bobath exercises

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.

Intervention Type: DIAGNOSTIC_TEST

Gasotransmitters

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.

Intervention Type: COMBINATION_PRODUCT

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.

• Minimum Eligible Age: 6 Years
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Superior University

OTHER

Sponsor Role: lead

Responsible Party

Muhammad Naveed Babur

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Ilaj Hospital

Chak One Hundred Seventy-five Nine Left, Punjab Province, Pakistan

Countries

Pakistan

Other Identifiers

MSRSW/Batch-Fall22/752

Identifier Type: -

Identifier Source: org_study_id