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To evaluate Gut Brain Axis on cerebral Palsy childre

Not Applicable
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
Inclusion Criteria

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.

Exclusion Criteria

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
NameTimeMethod
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
NameTimeMethod
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>
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