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Active, Not Recruiting

NCT Number: NCT06739538

Effects Of Bobath Exercises Combined With Gasotransmitter On Spastic Diplegic CP

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Cerebral Palsy Brain Damage, Chronic Brain Diseases Central Nervous System Diseases Nervous System Diseases

Age range

6 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ilaj Hospital

Guiranwala, Punjab Province, Pakistan

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

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.

Primary outcomes

  1. 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.

  2. 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:

Sponsors and collaborators

Lead sponsor

Superior University

Other

Registry information

Important dates

Study start
2024
Primary completion
2024
Study completion
2025
First posted
Dec 18, 2024
Registry last updated
Dec 18, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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