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Effects Of Bobath Exercises Combined With Gasotransmitter On Spastic Diplegic CP

S

Superior University

Status

Active, not recruiting

Conditions

Cerebral Palsy

Treatments

Combination Product: Gasotransmitters
Diagnostic Test: Bobath exercises

Study type

Interventional

Funder types

Other

Identifiers

NCT06739538
MSRSW/Batch-Fall22/752

Details and patient eligibility

About

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.

Full 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.

Enrollment

47 patients

Sex

All

Ages

6 to 18 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Health Services Research

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

47 participants in 2 patient groups

Bobath exercises
Experimental group
Treatment:
Diagnostic Test: Bobath exercises
Gasotransmitters
Active Comparator group
Treatment:
Combination Product: Gasotransmitters

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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