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CTRI Number  CTRI/2022/02/039899 [Registered on: 01/02/2022] Trial Registered Prospectively
Last Modified On: 01/02/2022
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Physiotherapy (Not Including YOGA) 
Study Design  Single Arm Study 
Public Title of Study   Comparative study of Neuro-Developmental Treatment and Electrical stimulation in cerebral palsy children. 
Scientific Title of Study   Effectiveness of Neuro-Developmental Treatment and Electrical stimulation on posture control and balance in children with Cerebral Palsy. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Nupur Jain 
Designation  Student 
Affiliation  Amity Institute of Physiotherapy 
Address  Amity Institute of Physiotherapy,Lower ground floor Amity University, Sector-125, Noida, Uttar Pradesh, India.

Gautam Buddha Nagar
UTTAR PRADESH
201313
India 
Phone  9461075670  
Fax    
Email  nupurjain390@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Pooja Sharma 
Designation  Assistant Professor 
Affiliation  Amity Institute of Physiotherapy 
Address  Amity Institute of Physiotherapy, Lower Ground Floor, Amity University, Sector-125, Noida, Uttar Pradesh, India.

Gautam Buddha Nagar
UTTAR PRADESH
201313
India 
Phone  9911472722  
Fax    
Email  psharma1@amity.edu  
 
Details of Contact Person
Public Query
 
Name  Nupur Jain 
Designation  Student 
Affiliation  Amity Institute of Physiotherapy 
Address  Amity Institute of Physiotherapy,Amity University, Sector-125, Noida, Uttar Pradesh, India.

Gautam Buddha Nagar
UTTAR PRADESH
201313
India 
Phone  9461075670  
Fax    
Email  nupurjain390@gmail.com  
 
Source of Monetary or Material Support  
Amity Institute of Physiotherapy 
 
Primary Sponsor  
Name  NA 
Address  NA 
Type of Sponsor  Other [NA] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Himandri Kapil  Reborn Physiotherapy & Neuro Rehab Centre.  238, basment, Subdhra Joshi Marg, Niti Khand I, Indirapuram, Ghaziabad, Uttar Pradesh 201014
Ghaziabad
UTTAR PRADESH 
9560809242

himandri.k@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee, Amity University, Noida, Uttar Pradesh  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: G809||Cerebral palsy, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Neuro-Developmental Treatment and Electrical Stimulation   Frequency- Neuro-developmental Treatment And Electrical Stimulation Duration- 4 days a week for 6 weeks 
Comparator Agent  Neuro-Developmental Treatment.  Frequency-Neuro-Developmental Treatment Only. Duration- 4 days a week for 6 weeks 
 
Inclusion Criteria  
Age From  5.00 Year(s)
Age To  15.00 Year(s)
Gender  Both 
Details  1. Acceptance of child’s participation in the study (by parents and/or their legal representatives)
2. CP diagnosed
3. Ages between 5-15 years
4. Cooperative
5. Walking independently or with a walking aid (Gross Motor Function Classification System (GMFCS) Level I, II or III)
 
 
ExclusionCriteria 
Details  1. Different diagnosis from CP
2. Children who cannot walk independently or at least with a walking aid (GMFCS Level IV or V)
3. To be not attended the assessments or the therapy sessions regularly. But all the participants were attended every session properly
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Postural control and Balance  Week-0, Week-6 
 
Secondary Outcome  
Outcome  TimePoints 
Motor Performance  Week-0, Week-6 
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   N/A 
Date of First Enrollment (India)   07/02/2022 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="0"
Months="2"
Days="15" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   NIL 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

A total of 30 subjects will be recruited in the study. An informed consent form will be given to all participants or parents. The motive of the study will be explained to the participants and parents. Participants will be divided into 2 groups: experimental and control.

Experimental group will be of cerebral palsy patients receiving Neuro-Developmental Treatment (Bobath Concept) combined with Electrical stimulation, Control group will include cerebral palsy patients receiving Neuro-Developmental Treatment (Bobath Concept) alone. In each group, an equal division of participants will be taken, with a ratio of 15:15.

A registration form will be filled for the subjects defining their demographics, CP clinical type, limb involvement, medical histories, walking aid use, surgical operation history, and NDT history.
Subjects will be assessed before and after the intervention through face-to-face interaction. Physiotherapist will assess the patient using the various scales like GMFCS and GMFM-88 for Gross motor function, Paediatric Balance Scale and Modified timed Up and Go Test (MTUGT) for balance. 

Experimental groups will receive training 1 hour. For 4 days for 6 weeks. Experimental Group will receive the NDT+ES. NDT includes Vestibular and proprioceptive training on balance board, Vestibular and proprioceptive training on exercise balls in different sizes. Dynamic balance training in sitting, kneeling, and standing position (eyes open and closed). Balance exercises in front of the mirror. Standing on one foot for improving the proprioceptive input (eyes open and closed). Balance training on the trampoline. Sensory stimulation for foot soles with various materials. Weight bearing exercises in sitting, crawling, kneeling, and standing position. Functional reaching and ball throwing-keeping exercises in various positions. Multi-task trainings. Walking trainings in different types. Climbing up & stepping down the stairs (supported-unsupported, symmetric, reciprocal etc.)

Electrical stimulation will be given over the paravertebral muscles when the subject is in sitting position. Pulse duration will be established as 14.65 microseconds with frequency of 60 Hz, and current strength will determine to form a tetanic contraction. Application duration will 10 minutes and the application frequency was 4 weeks/day for 6 weeks.

Electrical stimulation will be given inside lying position for gluteus maximus and in sitting position for quadriceps. During the application of neuromuscular electrical stimulation, child was positioned with the knee flexed (70-80 degree) and the hamstring will not in the lengthened position to reduce the amount of stimulation required to attain a forceful contraction and therefore improve comfort. The intervention period was of 6 weeks duration, electrical stimulation for 10 minutes each muscle, 4 days/week. Parameters used: Waveform- balance, symmetrical, biphasic; Pulse duration - 300 ms; Frequency 50 pulse/sec; Stimulation time: Rest time on:off 15:5, Ramp up – 1 sec, Ramp down- sec; Intensity - maximum tolerable intensity by the child. 

Control Group will receive only the Neurodevelopmental Treatment Protocol For 35 minutes for 4 day/week for 6 weeks.

 
 

 

 
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