To evaluate Gut Brain Axis on cerebral Palsy childre
- Conditions
- Health Condition 1: Q663- Other congenital varus deformitiesof feet
- Registration Number
- CTRI/2022/10/046338
- Lead Sponsor
- DrSuman Jain
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
1.Age 5-15 years.
2.All type of cerebral palsy Spastic CP or 3.Dyskinetic CP or Ataxic CP or Mixed CP with 4.Hemiplegia and Diplegia.
5.Intelligence quotient >50 (Binet Kamat test/ Malinââ?¬•s Intelligence scale for children).
6.Modified Ashworth scoring 1-3 for affected limb .
7.Can sit independently or with support (GMFCS stage: 1-4 and Manual ability classification system stage:1-3) .
7.Preserved vision and hearing (with or without correction).
8.Ability to follow instructions and complete testing or Task.
9.No formal cognitive assessment was performed in past 6 months.
1.Uncontrolled epilepsy as defined by seizure 2.frequency > 1/month for preceding 3 months.
3.� Severe concurrent illness of disease not 4.associated with CP or unstable medical conditions like pneumonia
5.Genetic or syndromic associations.
6.Children diagnosed with autistic spectrum disorders.
7.Modified Ashworth scale score >3 at shoulder/elbow/wrist.
8.Contractures of affected limb.
9.Severe movement disorder like dystonia, choreo-athetosis or ballismus interfering with purposeful limb movement.
10.Any congenital brain malformation detected on conventional MRI brain.
11.Any Malignancy/Cyst formation in the brain CT Scan or MRI Scan.
12.Recent orthopaedic surgery/ cast/splint in affected limb or any metallic implant.
13.Those receiving tone modifying agents.
On proton pump inhibitors 2 weeks before sample collection.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1.To investigate the alterations in gut motility, cognitive functions and cortical excitability in Cerebral Palsy Children. <br/ ><br>2.To correlate the impairment in gut motility, Autonomic Functions with severity of motor and cognitive deficits in CP. <br/ ><br>3.To compare the impairment of gut ââ?¬â??brain axis among All CP Patients. <br/ ><br>Timepoint: just before the intervention and after the intervention
- Secondary Outcome Measures
Name Time Method 1.To investigate the effect of probiotic on Gut motility ,motor ,cognitive deficits and cortical excitability in CP children. <br/ ><br> <br/ ><br>2.To assess metabolomic profiling of CP children by using LC MSMS. <br/ ><br> <br/ ><br>Timepoint: 1.To investigate the effect of probiotic on Gut motility ,motor ,cognitive deficits and cortical excitability in CP children. <br/ ><br> <br/ ><br>2.To assess metabolomic profiling of CP children by using LC MSMS. <br/ ><br> <br/ ><br>;1.To investigate the effect of probiotic on Gut motility ,motor ,cognitive deficits and cortical excitability in CP children. <br/ ><br> <br/ ><br>2.To assess metabolomic profiling of CP children by using LC MSMS. <br/ ><br> <br/ ><br>Timepoint: 1.To investigate the effect of probiotic on Gut motility ,motor ,cognitive deficits and cortical excitability in CP children. <br/ ><br> <br/ ><br>2.To assess metabolomic profiling of CP children by using LC MSMS. <br/ ><br> <br/ ><br>