Effects Of Bobath Exercises Combined With Gasotransmitter On Spastic Diplegic CP

December 13, 2024 updated by: Muhammad Naveed Babur, Superior University
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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

47

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Pakistan
    • Punjab
      • Gujrānwāla, Punjab, Pakistan
        • Ilaj Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Bobath exercises
Diagnostic test: 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.
Active Comparator: Gasotransmitters
Combination product: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
12 Months
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:
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Superior University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2024

Primary Completion (Actual)

September 1, 2024

Study Completion (Estimated)

February 28, 2025

Study Registration Dates

First Submitted

December 13, 2024

First Submitted That Met QC Criteria

December 13, 2024

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

December 13, 2024

Last Verified

December 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MSRSW/Batch-Fall22/752

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Subscribe