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CTRI Number  CTRI/2018/01/011096 [Registered on: 02/01/2018] Trial Registered Retrospectively
Last Modified On: 29/12/2017
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Physiotherapy (Not Including YOGA) 
Study Design  Other 
Public Title of Study   EFFECTS OF RHYTHMIC AUDITORY CUEING ALONG WITH TASK ORIENTED ACTIVITIES ON UPPER LIMB FUNCTIONS IN STROKE PATIENTS 
Scientific Title of Study   EFFECTS OF RHYTHMIC AUDITORY CUEING ALONG WITH TASK ORIENTED ACTIVITIES ON UPPER LIMB FUNCTIONS IN STROKE PATIENTS 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  NEHA KUMARI 
Designation  MPT STUDENT 
Affiliation  chitkara university 
Address  CHITKARA UNIVERSITY,RAJPURA

Patiala
PUNJAB
140401
India 
Phone  8054184634  
Fax    
Email  nehamanhas785@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr G K Balaji 
Designation  Prinicipal 
Affiliation  chitkara university 
Address  CHITKARA UNIVERSITY,RAJPURA

Patiala
PUNJAB
140401
India 
Phone  9041428339  
Fax    
Email  gkbalaji80@gmail.com  
 
Details of Contact Person
Public Query  
Name  NEHA KUMARI 
Designation  MPT STUDENT 
Affiliation  chitkara university 
Address  CHITKARA UNIVERSITY,RAJPURA

Patiala
PUNJAB
140401
India 
Phone  8054184634  
Fax    
Email  nehamanhas785@gmail.com  
 
Source of Monetary or Material Support  
chitkara university 
 
Primary Sponsor  
Name  chitkara university 
Address  chitkara university,rajpura,punjab 
Type of Sponsor  Other [university] 
 
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 
neha kumari  chitkara university  rajpura,punjab
Patiala
PUNJAB 		 8054184634
8054184634
nehamanhas785@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
institutional ethics committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  stroke ,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  TASK ORIENTED ACTIVITIES ALONG WITH RHYTHMIC AUDITORY STIMULATION  TASK ORIENTED ACTIVITIES ALONG WITH RAS FOR 6 WEEKS/5 DAYS/WEEK 
Comparator Agent  TASK ORIENTED ACTIVITIES ONLY  TASK ORIENTED ACTIVITIES ONLY FOR 6 WEEKS,5 DAYS /WEEK 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1 Age group 18-60 yrs
 
2 . Female and Male Stroke patients
 
3 . Between 3 months to 5 years post stroke

4 . Able to lift paretic hand onto a table , without assistance from unaffected hand and some finger movement
 
5 . Patients able to stand independently
 
6 . Not receiving any other treatment for upper limb paresis during the course of this study.
 
 
 
ExclusionCriteria 
Details  1 No hemineglect

2 Taking any medication that could influence balance or gait.

3 Significant cognitive deficit (MMSE <20/30)

4 Any orthopaedic disorder of the affected limb.

5 Cerebellar stroke
 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
finger dexterity,manual dexterity  0 week and 6th week 
 
Secondary Outcome  
Outcome  TimePoints 
muscle strenghth,functional movements and coordination  0 week and 6th week 
 
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   Phase 1 
Date of First Enrollment (India)   25/09/2017 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  25/09/2017 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="0"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details   not any 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary   Rythmic auditory stimulation has been to be beneficial for improving upper limb functions.But few studies is available on the effects of RAS on upper limb functions in stroke.There was no study has been found on task oriented therapy using rhythmic auditory stimulation on upper limb functional activities in stroke.In stroke patients very slow,late recovery of upper extremity occur and very less concern given to upper extremity.This study has been undertaken to see the effects of task oriented training along with rhythmic auditory stimulation so that a better and effective treatment for improving upper limb functions in stroke. 
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