Effects Of Bobath Exercises Combined With Gasotransmitter On Spastic Diplegic CP

NCT06739538 | Active Not Recruiting DMC

• 1 other identifier: MSRSW/Batch-Fall22/752
• Study Type: interventional
• Target: 47
• Locations: 1 country
• Sites: 1

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.

Conditions

Cerebral Palsy

Outcome Measures

Primary Outcomes (2)

• 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.

  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:

  12 months

Study Arms (2)

Bobath exercises

EXPERIMENTAL

Diagnostic Test: Bobath exercises

Gasotransmitters

ACTIVE COMPARATOR

Combination Product: Gasotransmitters

Interventions

Bobath exercises 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.

Bobath exercises

Gasotransmitters 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.

Gasotransmitters

Eligibility Criteria

• Age: 6 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Superior University: lead

Study Sites (1)

Ilaj Hospital

Gujranwala, Punjab Province, Pakistan

Location

MeSH Terms

Conditions

Cerebral Palsy

Interventions

Gasotransmitters

Condition Hierarchy (Ancestors)

Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Gases; Inorganic Chemicals; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 13, 2024
• First Posted: December 18, 2024
• Study Start: March 1, 2024
• Primary Completion: September 1, 2024
• Study Completion: February 28, 2025
• Last Updated: December 18, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)