Clinical trial NCT04894799: Vestibular Stimulation and Neurodevelopmental Technique on Hypotonic Cerebral Palsy While Controlling the Gender
Official title: Effects of Vestibular Stimulation and Neurodevelopmental Technique on Hypotonic Cerebral Palsy While Controlling the Gender
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cerebral Palsy
Hypotonia
Keywords: developmental milestones
hypotonia
vestibular stimulation
Lead sponsor: Riphah International University
Sponsor class: OTHER
First posted: 2021-05-20
Enrollment: 24
Sex: ALL
Minimum age (years): 6
Maximum age (years): 4
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: there is no such article found who specifies the effects of sensory integration therapies like vestibular stimulation technique or developmental milestone while controlling the gender of children with cerebral palsy. So, there is a need to do more research work on this in future to find out best treatment approach for children with cerebral palsy of their respective gender. That is why this study will focus on the results of vestibular stimulation and neurodevelopmental technique while controlling the Gender distribution of both intervention groups to find out the effects of these interventions that wither, they have some influence on the participants or not.

Detailed description: Bobath concept of neurodevelopment in children with cerebral palsy, is a problem-solving approach to the assessment and treatment of individuals with disturbances of tone, movement, and function due to a lesion of CNS, the goal of treatment is to optimize function by improving postural control and selective movement through facilitation. But also, no study found which specifically focuses the improvements on boys and girl's ratio or their gender-based improvements of tone or developmental milestones.

Different swings such as Infant Swing, frog swing, platform swing will be included as mode of Vestibular stimulation treatment. On the other side, Stimulation of vestibular system improved child's postural control and motor function in many studies.

Eligibility criteria: Inclusion Criteria:

* Hypotonic CP
* GMFM-88 ranges: With true score of zero (0) = does not initiates i.e., head control absent at age of 6 months
* Tone: 6 months infants total scoring ≤ 54 and 8 month or more total scoring ≤ 68 on Infant Neurological international Battery Scoring Sheet will be included.

Exclusion Criteria:

* Children with other Abnormalities and pathologies like Down syndrome, Joubert Syndrome

  * Children Undergone any kind of surgery like reconstruction surgeries for congenital defects of eyes, head, neck or all four limbs of the body
  * Children with other type of Cerebral Palsy (CP) like Spastic (Hypertonic), Choreoathetoid, Dystonic, Ataxia, Athetoid and mixed CP
  * Children with any other neurological deficits, Mentally Challenged.

Primary outcomes:
measure: Infant Neurological International Battery
timeFrame: 10 weeks
measure: GMFM-88
timeFrame: 10 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Chakwāl
country: Pakistan
facility: Helping Hand Comprehensive Rehabilitation Center
state: Punjab
Study officials:
affiliation: Riphah International University
name: Mirza Obaid Baig
role: PRINCIPAL_INVESTIGATOR
References: