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CTRI Number  CTRI/2017/09/009698 [Registered on: 11/09/2017] Trial Registered Retrospectively
Last Modified On: 24/11/2019
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Physiotherapy (Not Including YOGA) 
Study Design  Randomized, Parallel Group, Multiple Arm Trial 
Public Title of Study   Find out the role of Transcutaneus electrical nerve stimulation to enhancing upper limb function in spastic hemiplegic cerebral palsy children. 
Scientific Title of Study   Effects of Transcutaneous Electrical Nerve Stimulation on Upper Limb Functions in Spastic Cerebral Palsy Children - Randomized Controlled Study. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Satheeskumar Durairaj 
Designation  Assistant Professor 
Affiliation  P.P.G. College of Physiotherapy 
Address  9/1, Keeranatham Road, Saravanampatti, Coimbatore.

Coimbatore
TAMIL NADU
641 035
India 
Phone  04222669562  
Fax  04224221117  
Email  satheesdj@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dhaneshkumar 
Designation  Professor 
Affiliation  Nitte Institute of Physiotherapy 
Address  Principal, department of physiotherapy, Derlakatte, Mangalore.

Dakshina Kannada
KARNATAKA
575018
India 
Phone  08242202443  
Fax  08242204495  
Email  dhaneshphysio@yahoo.co.in  
 
Details of Contact Person
Public Query  
Name  Satheeskumar Durairaj 
Designation  Assistant Professor 
Affiliation  P.P.G College of Physiotherapy 
Address  9/1, Keeranatham Road, Saravanampatti, Coimbatore.

Coimbatore
TAMIL NADU
641 035
India 
Phone  04222669562  
Fax  04224221117  
Email  satheesdj@gmail.com  
 
Source of Monetary or Material Support  
K.S.Hegde Medical college hospital, Derlakatte, Mangalore, Karnataka, India. 575018. 
P.P.G College of Physiotherapy hospital, 9/1, Keeranatham road, Saravanampatti, Coimbatore, Tamilnadu, India, 641065 
 
Primary Sponsor  
Name  PPG College of physiotherapy 
Address  9/1, Keeranatham road, Saravanampatti, Coimbatore. 
Type of Sponsor  Private hospital/clinic 
 
Details of Secondary Sponsor  
Name  Address 
Dhanesh Kumar KU  Professor, Principal, Nitte Institute of Physiotherapy, Affiliated to Nitte University K.S.Hegde Medical Academy campus, Nithyandand nagr (po), Derlakatte, Mangalore, Karnataka. 
Rajasenthil  Professor, Principal, P.P.G College of Physiotherapy, Affiliated to the Tamilnadu Dr.MGR medical University 9/1, Keeranatham road, Saravanampatti, Coimbatore. 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 2  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dhaneshkumar  K.S.Hegde Medical college hospital  Physiotherapy department, Derlakatte, Mangalore, Karnataka – 575018
Dakshina Kannada
KARNATAKA 		 08242202443

dhaneshphysio@yahoo.co.in 
Satheeskumar  P.P.G College of Physiotherapy hospital  Physiotherapy Department, 9/1, Keeranatham road, Saravanampatti, Coimbatore.
Coimbatore
TAMIL NADU 		 04222669562

satheesdj@gmail.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Nitte University Central ethics committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied
Modification(s)  
Health Type  Condition 
Patients  (1) ICD-10 Condition: G811||Spastic hemiplegia, spastic hemiplegic cerebral palsy,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  active control   Conventional Physiotherapy consisted group stretching and strengthening exercise for upper limb muscle followed task oriented training for 90 minutes for 3 sessions per week for 8 weeks 
Comparator Agent  placebo  Placebo - Transcutaneous electrical nerve stimulation – no current delivered through electrode on selected upper limb motor points followed task oriented training for 90 minutes for 3 sessions per week for 8 weeks 
Intervention  Transcutaneous electrical nerve stimulation  Transcutaneous electrical nerve stimulation - pulse frequency 100 Hz, pulse width 200 µs current delivered through electrode on selected upper limb motor points followed task oriented training for 90 minutes for 3 sessions per week for 8 weeks 
 
Inclusion Criteria  
Age From  3.00 Year(s)
Age To  11.00 Year(s)
Gender  Both 
Details  Hemiplegic type of spastic cerebral palsy children with Gross Motor Function Classification System: level II – III and Manual ability classification system for children with cerebral palsy level less then IV.
 
 
ExclusionCriteria 
Details  other than spastic children with recent history of epilepsy and antispastic management with in 12 months 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   On-site computer system 
Blinding/Masking   Participant and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Mean of Quality of Upper Extremity Skill Test Score  8 weeks 
 
Secondary Outcome  
Outcome  TimePoints 
Mean of Modified Tardieus Scale Score   8 weeks 
Mean of ABILHAND-Kids Questionnaire Score  8 weeks 
Mean of Tactile Registration Score  8 weeks 
Mean of Two Point Discrimination Test Score  8 weeks 
Mean of Pickup Test Score  8 weeks 
 
Target Sample Size   Total Sample Size="120"
Sample Size from India="120" 
Final Enrollment numbers achieved (Total)= "90"
Final Enrollment numbers achieved (India)="90" 
Phase of Trial   N/A 
Date of First Enrollment (India)   01/03/2016 
Date of Study Completion (India) 07/07/2017 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) 07/07/2017 
Estimated Duration of Trial   Years="1"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details
Modification(s)  		 Satheeskumar Durairaj, Dhanesh Kumar K U, Rajasenthil K. The effects and safety of Transcutaneous Electrical Nerve Stimulation to improve upper limb function in Hemiplegic Cerebral Palsy – a Preliminary report. Indian journal of physiotherapy and occupational therapy – an international journal. 2017; 11(4): 124-129. Durairaj Satheeskumar , K.U. Dhaneshkumar, K Rajasenthil. A Comparative Study to Identify the Effects of Transcutaneous Electrical Nerve Stimulation Combined with Sensorimotor Task Oriented Training to Improve the Hand Function in Hemiplegic Cerebral Palsy Children. Journal of Clinical and Diagnostic Research. 2018; 12(1): YC17-YC21. Satheeskumar Durairaj, Dhaneshkumar K.U., Rajasenthil K, Ajay Thakur A. A study to find the effectiveness of cryotherapy with task oriented training in improving upper limb function in hemiplegic cerebral palsy. Int J Physiother Res. 2018; 6(1):2595-99 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary
Modification(s)  		 This study is randomized, single blind, placebo –controlled, parallel – group, multi-centre trial identifying efficacy of Transcutaneous Electrical Nerve Stimulation followed Task Oriented Training for 90 minutes per session for 3 days in a week for 8 weeks in 90 children with spastic hemiplegic cerebral palsy that was conducted in 2 centers in India. The primary outcome measures was the mean modified Tardieu scale Score at 8 weeks. The secondary outcomes were mean score of Quality of Upper Extremity Skill Test Score, ABILHAND-Kids questionnaire, single point tactile registration Score,  two point discrimination Score and Pickup Test Score  at 8 weeks. It showed significant improvement in the Quality of Upper Extremity Skill Test Score, ABILHAND-Kids questionnaire. moderate improvement noticed on modified Tardieu scale Score and Pickup Test Score. and very minimal improvment found on single point tactile registration Score, and two point discrimination Score. 
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